Cognitive Decline, Cardiovascular Diseases, Cognitive Dysfunction, Cognitive Impairment, Mild Cognitive Impairment
Conditions
Brief summary
Older women with cardiovascular disease (CVD) are at greater risk for memory loss, an important public health issue due to the negative effects to quality of life and health care costs. This research will be the first to examine the independent and combined effects of a lifestyle physical activity intervention and cognitive training on memory performance and memory-related serum biomarkers in this vulnerable population. The investigators will incorporate a practical lifestyle approach that can be delivered in the home and community settings to prevent or delay memory loss in older women with CVD.
Detailed description
Women experience disproportionately high rates of cognitive dysfunction, especially with increasing age, compared to men. Some research suggests that older women have a higher incidence of cognitive dysfunction with greater severity and more rapid decline.Furthermore, cardiovascular disease (CVD) increases the risk for cognitive dysfunction by 29-66% and affects 44 million women in the US. One particularly distressing type of cognitive dysfunction due to CVD is loss of memory. Memory loss leads to reduced independence, lower quality of life, and higher healthcare costs. To prevent or delay loss of memory among older women with CVD, there is an urgent need to develop lifestyle interventions that can be scaled. The long-term goal is to create and implement multi-modal lifestyle interventions (interventions that have multiple behavioral components) that will prevent or delay memory loss in older adults. The investigators initially focus on women with CVD due to their high risk. Physical activity interventions and cognitive training each prevent memory loss in healthy older adults. Thus, the investigators will evaluate the efficacy of MindMoves, a 24-week multi-modal intervention, on memory performance and memory-related serum biomarkers. The investigators will examine the serum biomarkers of brain-derived neurotrophic factor (BDNF), vascular endothelial growth factor (VEGF), and (c) insulin-like growth factor 1 (IGF-1). Data collection will occur at baseline, 24 weeks, 48 weeks, and 72 weeks. MindMoves is a combination of two evidence-based interventions. Mind is the cognitive training program BrainHQ modified to a lifestyle-focused electronic tablet format. Mind improves memory performance in healthy older adults and those with heart failure. Move is a modified lifestyle physical activity intervention from the Women's Lifestyle Physical Activity Program, which the investigators piloted in women with CVD. The investigators recently tested the feasibility of MindMoves. Using a 2x2 factorial design, the investigators will recruit 254 older women with CVD from cardiology clinics and randomize them to one of the following conditions: (1) Mind, (2) Move, (3) MindMoves, or (4) usual care control. This approach will allow us to evaluate main and interaction effects of Mind and/or Move on memory performance and memory-related biomarkers at 24, 48, and 72 weeks post-baseline. Specific Aim 1 (primary): Determine the independent and combined efficacies of Mind and Move on memory performance assessed by neurocognitive tests among women ≥ 65 years of age with CVD. Specific Aim 2 (secondary): Determine the independent and combined efficacies of Mind and Move on memory-related serum biomarkers (BDNF, VEGF, IGF-1) among women ≥ 65 years of age with CVD. Specific Aim 3 (exploratory): Evaluate depressive symptoms and genetic factors as potential moderators of the association between changes in target behaviors (physical activity and cognitive activity) and health outcomes (memory performance and relevant serum biomarkers). The investigators hypothesize that Mind and Move individually will each yield benefits to memory. However, it is hypothesized that the combined MindMoves will have a greater impact than the sum of the individual effects. Findings will provide key knowledge about the ability of practical multi-modal lifestyle interventions to target memory in older women with CVD.
Sponsors
Rush University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* self-identified as women * ≥ 65 years old * read/speak English * patient in the Rush Heart Center for Women * history of CVD (e.g., coronary artery disease, hypertension) and receiving guideline-directed medical therapy when appropriate * no regular moderate-vigorous physical activity (≥ 30 minutes ≥ 3 days per week in the past month) * no cognitive training program in the past month * no disabilities preventing regular physical activity (Physical Activity Readiness Questionnaire, which includes cardiac and lung disease symptoms) * written approval from cardiology provider (Physical Activity Readiness Medical Examination); no self-reported significant hearing loss that interferes with normal conversation * access to a Bluetooth-capable phone or tablet
Exclusion criteria
* symptoms of unstable cardiac or pulmonary disease in the past month (Physical Activity Readiness Questionnaire) * blood pressure (systolic ≥ 160 or diastolic ≥ 100 mm Hg) * cognitive status score \< 19 on the blind version (for phone administration) of the Montreal Cognitive Assessment (MoCA) consistent with significant cognitive impairment * diagnosis of a neurological disease found in the electronic health record (e.g., Alzheimer's disease dementia, Parkinson's disease, vascular dementia) * transient ischemic attack or small-vessel stroke in the past three months * taking anti-psychotic medication * diabetes with an A1C ≥ 9.0 within the past six months * end-stage renal disease on dialysis (Stage 5)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in East Boston Memory Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline | The East Boston Memory Test is a performance-based neurocognitive test. Participants are read a brief story with 12 key elements. The participants are asked to recall elements immediately and again after three-minute delay. Each score (immediate and delayed recall) has a scale of 0-12, with a higher score indicating better cognitive performance. The total score is an average of the two subscores for immediate and delayed recall. The total score has a scale of 0-12, with a higher score indicating better cognitive performance. |
| Change in Category Fluency Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline | The Category Fluency Test is a performance-based neurocognitive test. Participants are asked to generate examples for two semantic categories (animals, fruits/vegetables) in separate 60-second trials. There are two separate scores (number of animals generated, number of fruits/vegetables generated). A minimum possible score is 0, with an infinite possible maximum score, with a higher score indicating better cognitive performance. |
| Change in Digit Span Forwards and Backwards Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline | The Digit Span Forwards and Backwards Test is a performance-based neurocognitive test. The examiner says a string of numbers (digit span). For Digit Span Forwards, participant recites digit span, gradually increasing in length. Test stops when participant fails to recite digit span of same length twice. For Digit Span Backwards, participant recites digit span backwards. There are two separate scores (Digit Span Forwards correct responses, Digit Span Backwards correct responses). Digit Span Forwards scores can range from 0-16, with higher scores indicating higher cognitive performance. Digit Span Backwards Scores range from 0-14, with higher scores indicating higher cognitive performance. A total score is a sum of the two scores, with a range of 0-30, with higher scores indicating higher cognitive performance. |
| Change in Oral Trails A/B Tests Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline | First, participants are asked to count from 1 to 25 (Part A). For Part B, the person is asked to verbally recite alternating numbers and letters until they reach 13 and the letter M. The possible scores is a combined time to completion of both Part A and B summed. Possible minimum score is discontinued due to failure to complete the test (a zero score). The maximum score is 300 seconds. A lower score (fewer seconds) indicates higher cognitive performance. |
| Change in Digit Ordering Tests Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline | Participants are asked to memorize and immediately recall in ascending order a series of numbers that gradually increase in length with each trial. Possible scores range from 0-16, with a higher score indicating higher cognitive performance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Self-reported Physical Activity as Assessed by the Community Healthy Activities Model Program for Seniors (CHAMPS) Survey From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline | The Community Health Activities Model Program for Seniors (CHAMPS) is a 30-item self-report questionnaire that assesses the leisure time, household, and transportation physical activity in past two weeks. Participants are asked how long they participate in 30 different activities and at what frequency. Each activity is assigned intensity. Scores include mean minutes per week of light and moderate-vigorous physical activity for both leisure time and household scales (minimum score of 0 minutes and maximum score of 24 hours, with higher scores indicating more time spent in physical activity). |
| Change in Self-reported Cognitive Activity From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline | Self-report cognitive activity is a self-report questionnaire of participation in nine activities that involve information processing with minimal physical or social demands. Participants rate on a five-point scale. The score is an average of nine items (minimum score of 9, maximum score of 54 with higher scores indicating higher self-reported levels of cognitive activity). |
| Change in GT3XE-Plus Triaxial Accelerometer Minutes of Light Physical Activity From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline | The ActiGraph accelerometer is a motion sensor device that provides a valid assessment of physical activity in adult persons during treadmill Moveing/running and daily activity. The accelerometer records vertical accelerations as counts. Participants are instructed to wear on the hip for seven consecutive days during waking hours only, except while swimming or bathing. To analyze the accelerometer data, we will use the following physical activity intensity cut points: light 100-1,565 counts/min (\< 3 METS \[metabolic equivalent of task\]); moderate 1,566-6,139 (3.0-6.0 METS); vigorous ≥ 6,140 (≥ 6.1 METS). Findings are reported in mean daily minutes of light physical activity |
| Change in Brain-derived Neurotrophic Factor (BDNF) Levels From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline | We will obtain blood samples for BDNF. Pretreatment serum or plasma specimens will be prepared using standard techniques and archived at -80°C in aliquots with no specimen subjected to more than two freeze-thaw cycles. All assays performed in a blinded fashion and according to manufacturer's protocol using a 384-well modified method. Luminex FlexMAP 3D will be used with concentrations calculated based on 7-pt standard curves using a 5-parametric fit algorithm in xPONENT v4.0.3. Following recommendations, serum biomarkers will be obtained in the morning (8am-10am) following an 8-hour fast. |
| Change in Vascular Endothelial Growth Factor A (VEGF) Levels From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline | We will obtain blood samples for VEGF. Pretreatment serum or plasma specimens will be prepared using standard techniques and archived at -80°C in aliquots with no specimen subjected to more than two freeze-thaw cycles. All assays performed in a blinded fashion and according to manufacturer's protocol using a 384-well modified method. Luminex FlexMAP 3D will be used with concentrations calculated based on 7-pt standard curves using a 5-parametric fit algorithm in xPONENT v4.0.3. Following recommendations, serum biomarkers will be obtained in the morning (8am-10am) following an 8-hour fast. |
| Change in Insulin-like Growth Factor 1 (IGF-1) From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline | We will obtain blood samples for IGF-1. Pretreatment serum or plasma specimens will be prepared using standard techniques and archived at -80°C in aliquots with no specimen subjected to more than two freeze-thaw cycles. All assays performed in a blinded fashion and according to manufacturer's protocol using a 384-well modified method. Luminex FlexMAP 3D will be used with concentrations calculated based on 7-pt standard curves using a 5-parametric fit algorithm in xPONENT v4.0.3. Following recommendations, serum biomarkers will be obtained in the morning (8am-10am) following an 8-hour fast. |
| Change in GT3XE-Plus Triaxial Accelerometer Minutes of Moderate Vigorous Physical Activity From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline | The ActiGraph accelerometer is a motion sensor device that provides a valid assessment of physical activity in adult persons during treadmill Moveing/running and daily activity. The accelerometer records vertical accelerations as counts. Participants are instructed to wear on the hip for seven consecutive days during waking hours only, except while swimming or bathing. To analyze the accelerometer data, we will use the following physical activity intensity cut points: light 100-1,565 counts/min (\< 3 METS \[metabolic equivalent of task\]); moderate 1,566-6,139 (3.0-6.0 METS); vigorous ≥ 6,140 (≥ 6.1 METS). Findings are reported in mean daily minutes of moderate-vigorous physical activity |
| Change in the Two-minute Step Test of Aerobic Fitness Score From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline | This is a test of aerobic fitness that can be performed in a small space using minimal equipment. Participants step in place to a predesignated height for two minutes. This test is correlated with treadmill tests of aerobic fitness. The score is number of valid steps achieved reaching the predesignated height in two minutes. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Level and Change in Center for Epidemiologic Studies-Depression Scale Score From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks. | Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline | Depressive symptoms will be evaluated as a potential moderator. The Center for Epidemiologic Studies-Depression Scale (20 items scored 0-3) assesses symptoms of depressed mood, feelings of guilt and worthlessness, feelings of helplessness and hopelessness, psychomotor retardation, loss of appetite, and sleep disturbance. Participants who score ≥ 16 will be referred to their primary/ psychiatric provider for further evaluation and treatment. Scores range from 0-60, with higher score indicating more depressive symptoms. |
| Apolipoprotein [APOE]- ε4 Allele | Baseline | Potential moderator. Candidate gene analysis with DNA extraction from whole blood samples using an Autogen DNA isolation kit (Qiagen, Venlo, Netherlands). Participants will be characterized by APOE genotype and subdivided into two groups of patients in whom the APOE ε4 allele was absent or present. |
| Brain-derived Neurotrophic Factor (BDNF) Val66Met Polymorphism | Baseline | Potential moderator. Val66Met polymorphism in the BDNF gene assessed using candidate genotyping. The BDNF gene locus is located on Chromosome 11. BDNF Met positive genotypes are heterozygous Val/Met or homozygous Met/Met. Results will be reported as presence of Met allele or absence of Met allele |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from two cardiology clinics (one at an academic medical center and one at a nearby community hospital affiliated with the academic medical center) in an urban Midwest area. The study was conducted from 2020 to 2024 in Chicago, Illinois, with enrollment from October 2020 to May 2022 (planned target enrollment achieved), and a final follow-up January 2024.
Pre-assignment details
A total of 24 cohorts (12 cohorts per each of the two clinic sites) of 10-11 participants each were recruited sequentially prior to baseline assessment. Cluster randomization was used to assign cohorts to cells due to the Move intervention being group-based. Following randomization, the intervention condition was revealed and started at the intervention orientation.
Participants by arm
| Arm | Count |
|---|---|
| Mind - BrainHQ Cognitive Training Intervention The Mind intervention uses the evidence-based BrainHQ computerized cognitive training program. BrainHQ focuses on improving memory, attention, sensory function, and working memory, and has demonstrated efficacy in improving memory among healthy older adults and adults with heart failure. BrainHQ is tailored to the individual, and program difficulty automatically progresses based on performance. Training occurs during three 30-minute sessions per week, for a total of 36 hours. Participants will complete the BrainHQ program on an iPad tablet, which will be provided to them.
Mind: See arm description. | 64 |
| Move - Lifestyle Physical Activity Intervention The Move intervention is a 24-week evidence-based program based on social cognitive theory. It was originally developed for midlife women and successfully maintained increased physical activity. It has since been tailored for older women with CVD to prevent or delay cognitive decline, and includes: (1) education on the importance of lifestyle physical activity for brain health, (2) increasing lifestyle physical activity while considering CVD, and (3) including a goal for increasing Fitbit active minutes (≥ 3 METs or moderate-intensity physical activity) to ensure participants are obtaining the beneficial aerobic fitness effects during periods of lifestyle physical activity. Core elements include a personal lifestyle physical activity goal and five group meetings.
Move: See arm description. | 61 |
| MindMoves - Cognitive Training and Lifestyle Physical Activity Participants who are assigned to this condition will complete both the Move lifestyle physical activity program and the Mind BrainHQ cognitive training intervention simultaneously for 24 weeks (see Move and Mind descriptions). Participants will receive both a Fitbit and iPad tablet to complete the combined MindMoves intervention.
Mind: See arm description.
Move: See arm description. | 64 |
| Usual Care Participants in the usual care group do not receive any Mind- or Move-related intervention, and will receive their usual care from their cardiology provider. | 64 |
| Total | 253 |
Baseline characteristics
| Characteristic | Mind - BrainHQ Cognitive Training Intervention | Move - Lifestyle Physical Activity Intervention | MindMoves - Cognitive Training and Lifestyle Physical Activity | Usual Care | Total |
|---|---|---|---|---|---|
| Age, Continuous | 74.3 years STANDARD_DEVIATION 6.5 | 71.8 years STANDARD_DEVIATION 5.7 | 72.5 years STANDARD_DEVIATION 5.2 | 72.4 years STANDARD_DEVIATION 5.8 | 72.8 years STANDARD_DEVIATION 5.9 |
| Highest education level - College graduate | 44 Participants | 35 Participants | 37 Participants | 35 Participants | 151 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Latina/Hispanic | 2 Participants | 1 Participants | 3 Participants | 1 Participants | 7 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black or African American | 26 Participants | 26 Participants | 25 Participants | 23 Participants | 100 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 35 Participants | 34 Participants | 34 Participants | 40 Participants | 143 Participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Female | 64 Participants | 61 Participants | 64 Participants | 64 Participants | 253 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 64 | 2 / 61 | 1 / 64 | 1 / 64 |
| other Total, other adverse events | 4 / 64 | 6 / 61 | 6 / 64 | 5 / 64 |
| serious Total, serious adverse events | 1 / 64 | 1 / 61 | 0 / 64 | 2 / 64 |
Outcome results
Primary
Change in Category Fluency Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
The Category Fluency Test is a performance-based neurocognitive test. Participants are asked to generate examples for two semantic categories (animals, fruits/vegetables) in separate 60-second trials. There are two separate scores (number of animals generated, number of fruits/vegetables generated). A minimum possible score is 0, with an infinite possible maximum score, with a higher score indicating better cognitive performance.
Time frame: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline
Population: Intent to treat analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mind - BrainHQ Cognitive Training Intervention | Change in Category Fluency Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 72 weeks | 0.04 score on a scale | Standard Error 0.08 |
| Mind - BrainHQ Cognitive Training Intervention | Change in Category Fluency Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 24 weeks | -0.08 score on a scale | Standard Error 0.08 |
| Mind - BrainHQ Cognitive Training Intervention | Change in Category Fluency Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 48 weeks | 0.09 score on a scale | Standard Error 0.08 |
| Move - Lifestyle Physical Activity Intervention | Change in Category Fluency Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 48 weeks | 0.06 score on a scale | Standard Error 0.08 |
| Move - Lifestyle Physical Activity Intervention | Change in Category Fluency Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 24 weeks | 0.03 score on a scale | Standard Error 0.08 |
| Move - Lifestyle Physical Activity Intervention | Change in Category Fluency Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 72 weeks | 0.09 score on a scale | Standard Error 0.08 |
| MindMoves - Cognitive Training and Lifestyle Physical Activity | Change in Category Fluency Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 72 weeks | -0.05 score on a scale | Standard Error 0.09 |
| MindMoves - Cognitive Training and Lifestyle Physical Activity | Change in Category Fluency Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 24 weeks | 0.04 score on a scale | Standard Error 0.08 |
| MindMoves - Cognitive Training and Lifestyle Physical Activity | Change in Category Fluency Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 48 weeks | 0.08 score on a scale | Standard Error 0.09 |
| Usual Care | Change in Category Fluency Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 48 weeks | 0.03 score on a scale | Standard Error 0.08 |
| Usual Care | Change in Category Fluency Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 24 weeks | 0.18 score on a scale | Standard Error 0.08 |
| Usual Care | Change in Category Fluency Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 72 weeks | 0.09 score on a scale | Standard Error 0.08 |
Comparison: Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over timep-value: 0.179Mixed Models Analysis
Comparison: Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over timep-value: 0.91Mixed Models Analysis
Comparison: Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over timep-value: 0.159Mixed Models Analysis
Primary
Change in Digit Ordering Tests Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
Participants are asked to memorize and immediately recall in ascending order a series of numbers that gradually increase in length with each trial. Possible scores range from 0-16, with a higher score indicating higher cognitive performance.
Time frame: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline
Population: intent to treat analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mind - BrainHQ Cognitive Training Intervention | Change in Digit Ordering Tests Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 24 weeks | -0.14 score on a scale | Standard Error 0.09 |
| Mind - BrainHQ Cognitive Training Intervention | Change in Digit Ordering Tests Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 72 weeks | -0.06 score on a scale | Standard Error 0.1 |
| Mind - BrainHQ Cognitive Training Intervention | Change in Digit Ordering Tests Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 48 weeks | 0.02 score on a scale | Standard Error 0.09 |
| Move - Lifestyle Physical Activity Intervention | Change in Digit Ordering Tests Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 24 weeks | -0.04 score on a scale | Standard Error 0.09 |
| Move - Lifestyle Physical Activity Intervention | Change in Digit Ordering Tests Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 72 weeks | 0.18 score on a scale | Standard Error 0.09 |
| Move - Lifestyle Physical Activity Intervention | Change in Digit Ordering Tests Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 48 weeks | 0.12 score on a scale | Standard Error 0.09 |
| MindMoves - Cognitive Training and Lifestyle Physical Activity | Change in Digit Ordering Tests Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 48 weeks | 0.19 score on a scale | Standard Error 0.1 |
| MindMoves - Cognitive Training and Lifestyle Physical Activity | Change in Digit Ordering Tests Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 24 weeks | -0.01 score on a scale | Standard Error 0.09 |
| MindMoves - Cognitive Training and Lifestyle Physical Activity | Change in Digit Ordering Tests Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 72 weeks | -0.08 score on a scale | Standard Error 0.1 |
| Usual Care | Change in Digit Ordering Tests Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 24 weeks | -0.12 score on a scale | Standard Error 0.09 |
| Usual Care | Change in Digit Ordering Tests Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 72 weeks | -0.06 score on a scale | Standard Error 0.09 |
| Usual Care | Change in Digit Ordering Tests Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 48 weeks | -0.16 score on a scale | Standard Error 0.09 |
Comparison: Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over timep-value: 0.078Mixed Models Analysis
Comparison: Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over timep-value: 0.13Mixed Models Analysis
Comparison: Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over timep-value: 0.43Mixed Models Analysis
Primary
Change in Digit Span Forwards and Backwards Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
The Digit Span Forwards and Backwards Test is a performance-based neurocognitive test. The examiner says a string of numbers (digit span). For Digit Span Forwards, participant recites digit span, gradually increasing in length. Test stops when participant fails to recite digit span of same length twice. For Digit Span Backwards, participant recites digit span backwards. There are two separate scores (Digit Span Forwards correct responses, Digit Span Backwards correct responses). Digit Span Forwards scores can range from 0-16, with higher scores indicating higher cognitive performance. Digit Span Backwards Scores range from 0-14, with higher scores indicating higher cognitive performance. A total score is a sum of the two scores, with a range of 0-30, with higher scores indicating higher cognitive performance.
Time frame: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline
Population: Intent to treat analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mind - BrainHQ Cognitive Training Intervention | Change in Digit Span Forwards and Backwards Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 24 weeks | -0.14 score on a scale | Standard Error 0.09 |
| Mind - BrainHQ Cognitive Training Intervention | Change in Digit Span Forwards and Backwards Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 72 weeks | 0.06 score on a scale | Standard Error 0.1 |
| Mind - BrainHQ Cognitive Training Intervention | Change in Digit Span Forwards and Backwards Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 48 weeks | 0.02 score on a scale | Standard Error 0.09 |
| Move - Lifestyle Physical Activity Intervention | Change in Digit Span Forwards and Backwards Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 24 weeks | -0.04 score on a scale | Standard Error 0.09 |
| Move - Lifestyle Physical Activity Intervention | Change in Digit Span Forwards and Backwards Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 72 weeks | 0.18 score on a scale | Standard Error 0.09 |
| Move - Lifestyle Physical Activity Intervention | Change in Digit Span Forwards and Backwards Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 48 weeks | 0.12 score on a scale | Standard Error 0.09 |
| MindMoves - Cognitive Training and Lifestyle Physical Activity | Change in Digit Span Forwards and Backwards Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 48 weeks | 0.19 score on a scale | Standard Error 0.1 |
| MindMoves - Cognitive Training and Lifestyle Physical Activity | Change in Digit Span Forwards and Backwards Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 24 weeks | -0.01 score on a scale | Standard Error 0.09 |
| MindMoves - Cognitive Training and Lifestyle Physical Activity | Change in Digit Span Forwards and Backwards Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 72 weeks | -0.08 score on a scale | Standard Error 0.1 |
| Usual Care | Change in Digit Span Forwards and Backwards Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 24 weeks | -0.12 score on a scale | Standard Error 0.09 |
| Usual Care | Change in Digit Span Forwards and Backwards Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 72 weeks | -0.06 score on a scale | Standard Error 0.09 |
| Usual Care | Change in Digit Span Forwards and Backwards Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 48 weeks | -0.16 score on a scale | Standard Error 0.09 |
Comparison: Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over timep-value: 0.078Mixed Models Analysis
Comparison: Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over timep-value: 0.13Mixed Models Analysis
Comparison: Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over timep-value: 0.43Mixed Models Analysis
Primary
Change in East Boston Memory Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
The East Boston Memory Test is a performance-based neurocognitive test. Participants are read a brief story with 12 key elements. The participants are asked to recall elements immediately and again after three-minute delay. Each score (immediate and delayed recall) has a scale of 0-12, with a higher score indicating better cognitive performance. The total score is an average of the two subscores for immediate and delayed recall. The total score has a scale of 0-12, with a higher score indicating better cognitive performance.
Time frame: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline
Population: Intent to treat analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mind - BrainHQ Cognitive Training Intervention | Change in East Boston Memory Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 24 weeks | 0.03 score on a scale | Standard Error 0.13 |
| Mind - BrainHQ Cognitive Training Intervention | Change in East Boston Memory Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 72 weeks | 0.07 score on a scale | Standard Error 0.13 |
| Mind - BrainHQ Cognitive Training Intervention | Change in East Boston Memory Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 48 weeks | 0.00 score on a scale | Standard Error 0.13 |
| Move - Lifestyle Physical Activity Intervention | Change in East Boston Memory Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 24 weeks | -0.02 score on a scale | Standard Error 0.13 |
| Move - Lifestyle Physical Activity Intervention | Change in East Boston Memory Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 72 weeks | 0.15 score on a scale | Standard Error 0.13 |
| Move - Lifestyle Physical Activity Intervention | Change in East Boston Memory Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 48 weeks | 0.04 score on a scale | Standard Error 0.13 |
| MindMoves - Cognitive Training and Lifestyle Physical Activity | Change in East Boston Memory Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 48 weeks | 0.28 score on a scale | Standard Error 0.13 |
| MindMoves - Cognitive Training and Lifestyle Physical Activity | Change in East Boston Memory Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 24 weeks | 0.01 score on a scale | Standard Error 0.13 |
| MindMoves - Cognitive Training and Lifestyle Physical Activity | Change in East Boston Memory Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 72 weeks | 0.03 score on a scale | Standard Error 0.13 |
| Usual Care | Change in East Boston Memory Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 24 weeks | 0.05 score on a scale | Standard Error 0.13 |
| Usual Care | Change in East Boston Memory Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 72 weeks | 0.23 score on a scale | Standard Error 0.13 |
| Usual Care | Change in East Boston Memory Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 48 weeks | 0.06 score on a scale | Standard Error 0.13 |
Comparison: Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over timep-value: 0.409Mixed Models Analysis
Comparison: Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over timep-value: 0.456Mixed Models Analysis
Comparison: Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over timep-value: 0.692Mixed Models Analysis
Primary
Change in Oral Trails A/B Tests Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
First, participants are asked to count from 1 to 25 (Part A). For Part B, the person is asked to verbally recite alternating numbers and letters until they reach 13 and the letter M. The possible scores is a combined time to completion of both Part A and B summed. Possible minimum score is discontinued due to failure to complete the test (a zero score). The maximum score is 300 seconds. A lower score (fewer seconds) indicates higher cognitive performance.
Time frame: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline
Population: Intent to treat analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mind - BrainHQ Cognitive Training Intervention | Change in Oral Trails A/B Tests Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 24 weeks | 0.29 seconds | Standard Error 0.12 |
| Mind - BrainHQ Cognitive Training Intervention | Change in Oral Trails A/B Tests Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 72 weeks | 0.24 seconds | Standard Error 0.12 |
| Mind - BrainHQ Cognitive Training Intervention | Change in Oral Trails A/B Tests Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 48 weeks | 0.40 seconds | Standard Error 0.12 |
| Move - Lifestyle Physical Activity Intervention | Change in Oral Trails A/B Tests Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 24 weeks | 0.12 seconds | Standard Error 0.12 |
| Move - Lifestyle Physical Activity Intervention | Change in Oral Trails A/B Tests Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 72 weeks | 0.29 seconds | Standard Error 0.12 |
| Move - Lifestyle Physical Activity Intervention | Change in Oral Trails A/B Tests Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 48 weeks | 0.06 seconds | Standard Error 0.12 |
| MindMoves - Cognitive Training and Lifestyle Physical Activity | Change in Oral Trails A/B Tests Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 48 weeks | 0.09 seconds | Standard Error 0.12 |
| MindMoves - Cognitive Training and Lifestyle Physical Activity | Change in Oral Trails A/B Tests Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 24 weeks | 0.14 seconds | Standard Error 0.12 |
| MindMoves - Cognitive Training and Lifestyle Physical Activity | Change in Oral Trails A/B Tests Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 72 weeks | 0.28 seconds | Standard Error 0.12 |
| Usual Care | Change in Oral Trails A/B Tests Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 24 weeks | 0.17 seconds | Standard Error 0.12 |
| Usual Care | Change in Oral Trails A/B Tests Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 72 weeks | 0.23 seconds | Standard Error 0.12 |
| Usual Care | Change in Oral Trails A/B Tests Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 48 weeks | 0.22 seconds | Standard Error 0.12 |
Comparison: Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over timep-value: 0.772Mixed Models Analysis
Comparison: Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over timep-value: 0.107Mixed Models Analysis
Comparison: Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over timep-value: 0.915Mixed Models Analysis
Secondary
Change in Brain-derived Neurotrophic Factor (BDNF) Levels From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
We will obtain blood samples for BDNF. Pretreatment serum or plasma specimens will be prepared using standard techniques and archived at -80°C in aliquots with no specimen subjected to more than two freeze-thaw cycles. All assays performed in a blinded fashion and according to manufacturer's protocol using a 384-well modified method. Luminex FlexMAP 3D will be used with concentrations calculated based on 7-pt standard curves using a 5-parametric fit algorithm in xPONENT v4.0.3. Following recommendations, serum biomarkers will be obtained in the morning (8am-10am) following an 8-hour fast.
Time frame: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mind - BrainHQ Cognitive Training Intervention | Change in Brain-derived Neurotrophic Factor (BDNF) Levels From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 24 weeks | .01 log-transformed pg/mL | Standard Error 0.04 |
| Mind - BrainHQ Cognitive Training Intervention | Change in Brain-derived Neurotrophic Factor (BDNF) Levels From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 72 weeks | .01 log-transformed pg/mL | Standard Error 0.04 |
| Mind - BrainHQ Cognitive Training Intervention | Change in Brain-derived Neurotrophic Factor (BDNF) Levels From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 48 weeks | .05 log-transformed pg/mL | Standard Error 0.04 |
| Move - Lifestyle Physical Activity Intervention | Change in Brain-derived Neurotrophic Factor (BDNF) Levels From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 24 weeks | .05 log-transformed pg/mL | Standard Error 0.04 |
| Move - Lifestyle Physical Activity Intervention | Change in Brain-derived Neurotrophic Factor (BDNF) Levels From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 72 weeks | .05 log-transformed pg/mL | Standard Error 0.04 |
| Move - Lifestyle Physical Activity Intervention | Change in Brain-derived Neurotrophic Factor (BDNF) Levels From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 48 weeks | .05 log-transformed pg/mL | Standard Error 0.04 |
| MindMoves - Cognitive Training and Lifestyle Physical Activity | Change in Brain-derived Neurotrophic Factor (BDNF) Levels From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 48 weeks | .06 log-transformed pg/mL | Standard Error 0.04 |
| MindMoves - Cognitive Training and Lifestyle Physical Activity | Change in Brain-derived Neurotrophic Factor (BDNF) Levels From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 24 weeks | .05 log-transformed pg/mL | Standard Error 0.04 |
| MindMoves - Cognitive Training and Lifestyle Physical Activity | Change in Brain-derived Neurotrophic Factor (BDNF) Levels From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 72 weeks | -.01 log-transformed pg/mL | Standard Error 0.04 |
| Usual Care | Change in Brain-derived Neurotrophic Factor (BDNF) Levels From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 24 weeks | .05 log-transformed pg/mL | Standard Error 0.04 |
| Usual Care | Change in Brain-derived Neurotrophic Factor (BDNF) Levels From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 72 weeks | .05 log-transformed pg/mL | Standard Error 0.04 |
| Usual Care | Change in Brain-derived Neurotrophic Factor (BDNF) Levels From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 48 weeks | .05 log-transformed pg/mL | Standard Error 0.04 |
Comparison: Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over timep-value: 0.487Mixed Models Analysis
Comparison: Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over timep-value: 0.827Mixed Models Analysis
Comparison: Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over timep-value: 0.908Mixed Models Analysis
Secondary
Change in GT3XE-Plus Triaxial Accelerometer Minutes of Light Physical Activity From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
The ActiGraph accelerometer is a motion sensor device that provides a valid assessment of physical activity in adult persons during treadmill Moveing/running and daily activity. The accelerometer records vertical accelerations as counts. Participants are instructed to wear on the hip for seven consecutive days during waking hours only, except while swimming or bathing. To analyze the accelerometer data, we will use the following physical activity intensity cut points: light 100-1,565 counts/min (\< 3 METS \[metabolic equivalent of task\]); moderate 1,566-6,139 (3.0-6.0 METS); vigorous ≥ 6,140 (≥ 6.1 METS). Findings are reported in mean daily minutes of light physical activity
Time frame: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mind - BrainHQ Cognitive Training Intervention | Change in GT3XE-Plus Triaxial Accelerometer Minutes of Light Physical Activity From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 24 weeks | -10.04 daily minutes | Standard Error 6.96 |
| Mind - BrainHQ Cognitive Training Intervention | Change in GT3XE-Plus Triaxial Accelerometer Minutes of Light Physical Activity From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 72 weeks | 2.46 daily minutes | Standard Error 7.18 |
| Mind - BrainHQ Cognitive Training Intervention | Change in GT3XE-Plus Triaxial Accelerometer Minutes of Light Physical Activity From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 48 weeks | 6.62 daily minutes | Standard Error 7.32 |
| Move - Lifestyle Physical Activity Intervention | Change in GT3XE-Plus Triaxial Accelerometer Minutes of Light Physical Activity From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 24 weeks | 2.83 daily minutes | Standard Error 6.76 |
| Move - Lifestyle Physical Activity Intervention | Change in GT3XE-Plus Triaxial Accelerometer Minutes of Light Physical Activity From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 72 weeks | -6.40 daily minutes | Standard Error 6.76 |
| Move - Lifestyle Physical Activity Intervention | Change in GT3XE-Plus Triaxial Accelerometer Minutes of Light Physical Activity From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 48 weeks | -12.49 daily minutes | Standard Error 6.8 |
| MindMoves - Cognitive Training and Lifestyle Physical Activity | Change in GT3XE-Plus Triaxial Accelerometer Minutes of Light Physical Activity From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 48 weeks | -3.84 daily minutes | Standard Error 7.49 |
| MindMoves - Cognitive Training and Lifestyle Physical Activity | Change in GT3XE-Plus Triaxial Accelerometer Minutes of Light Physical Activity From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 24 weeks | 2.13 daily minutes | Standard Error 7.13 |
| MindMoves - Cognitive Training and Lifestyle Physical Activity | Change in GT3XE-Plus Triaxial Accelerometer Minutes of Light Physical Activity From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 72 weeks | -8.08 daily minutes | Standard Error 7.22 |
| Usual Care | Change in GT3XE-Plus Triaxial Accelerometer Minutes of Light Physical Activity From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 24 weeks | .09 daily minutes | Standard Error 6.99 |
| Usual Care | Change in GT3XE-Plus Triaxial Accelerometer Minutes of Light Physical Activity From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 72 weeks | -3.21 daily minutes | Standard Error 7.13 |
| Usual Care | Change in GT3XE-Plus Triaxial Accelerometer Minutes of Light Physical Activity From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 48 weeks | -3.47 daily minutes | Standard Error 6.85 |
Comparison: Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over timep-value: 0.244Mixed Models Analysis
Comparison: Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over timep-value: 0.085Mixed Models Analysis
Comparison: Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over timep-value: 0.71Mixed Models Analysis
Secondary
Change in GT3XE-Plus Triaxial Accelerometer Minutes of Moderate Vigorous Physical Activity From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
The ActiGraph accelerometer is a motion sensor device that provides a valid assessment of physical activity in adult persons during treadmill Moveing/running and daily activity. The accelerometer records vertical accelerations as counts. Participants are instructed to wear on the hip for seven consecutive days during waking hours only, except while swimming or bathing. To analyze the accelerometer data, we will use the following physical activity intensity cut points: light 100-1,565 counts/min (\< 3 METS \[metabolic equivalent of task\]); moderate 1,566-6,139 (3.0-6.0 METS); vigorous ≥ 6,140 (≥ 6.1 METS). Findings are reported in mean daily minutes of moderate-vigorous physical activity
Time frame: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mind - BrainHQ Cognitive Training Intervention | Change in GT3XE-Plus Triaxial Accelerometer Minutes of Moderate Vigorous Physical Activity From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 24 weeks | -.10 log-transformed minutes | Standard Error 0.1 |
| Mind - BrainHQ Cognitive Training Intervention | Change in GT3XE-Plus Triaxial Accelerometer Minutes of Moderate Vigorous Physical Activity From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 72 weeks | -.13 log-transformed minutes | Standard Error 0.1 |
| Mind - BrainHQ Cognitive Training Intervention | Change in GT3XE-Plus Triaxial Accelerometer Minutes of Moderate Vigorous Physical Activity From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 48 weeks | -.13 log-transformed minutes | Standard Error 0.1 |
| Move - Lifestyle Physical Activity Intervention | Change in GT3XE-Plus Triaxial Accelerometer Minutes of Moderate Vigorous Physical Activity From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 24 weeks | .03 log-transformed minutes | Standard Error 0.09 |
| Move - Lifestyle Physical Activity Intervention | Change in GT3XE-Plus Triaxial Accelerometer Minutes of Moderate Vigorous Physical Activity From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 72 weeks | -.18 log-transformed minutes | Standard Error 0.09 |
| Move - Lifestyle Physical Activity Intervention | Change in GT3XE-Plus Triaxial Accelerometer Minutes of Moderate Vigorous Physical Activity From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 48 weeks | -.13 log-transformed minutes | Standard Error 0.09 |
| MindMoves - Cognitive Training and Lifestyle Physical Activity | Change in GT3XE-Plus Triaxial Accelerometer Minutes of Moderate Vigorous Physical Activity From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 48 weeks | -.10 log-transformed minutes | Standard Error 0.1 |
| MindMoves - Cognitive Training and Lifestyle Physical Activity | Change in GT3XE-Plus Triaxial Accelerometer Minutes of Moderate Vigorous Physical Activity From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 24 weeks | .06 log-transformed minutes | Standard Error 0.1 |
| MindMoves - Cognitive Training and Lifestyle Physical Activity | Change in GT3XE-Plus Triaxial Accelerometer Minutes of Moderate Vigorous Physical Activity From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 72 weeks | -.12 log-transformed minutes | Standard Error 0.1 |
| Usual Care | Change in GT3XE-Plus Triaxial Accelerometer Minutes of Moderate Vigorous Physical Activity From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 24 weeks | .11 log-transformed minutes | Standard Error 0.1 |
| Usual Care | Change in GT3XE-Plus Triaxial Accelerometer Minutes of Moderate Vigorous Physical Activity From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 72 weeks | .03 log-transformed minutes | Standard Error 0.1 |
| Usual Care | Change in GT3XE-Plus Triaxial Accelerometer Minutes of Moderate Vigorous Physical Activity From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 48 weeks | -.17 log-transformed minutes | Standard Error 0.09 |
Comparison: Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over timep-value: 0.619Mixed Models Analysis
Comparison: Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over timep-value: 0.468Mixed Models Analysis
Comparison: Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over timep-value: 0.387Mixed Models Analysis
Secondary
Change in Insulin-like Growth Factor 1 (IGF-1) From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
We will obtain blood samples for IGF-1. Pretreatment serum or plasma specimens will be prepared using standard techniques and archived at -80°C in aliquots with no specimen subjected to more than two freeze-thaw cycles. All assays performed in a blinded fashion and according to manufacturer's protocol using a 384-well modified method. Luminex FlexMAP 3D will be used with concentrations calculated based on 7-pt standard curves using a 5-parametric fit algorithm in xPONENT v4.0.3. Following recommendations, serum biomarkers will be obtained in the morning (8am-10am) following an 8-hour fast.
Time frame: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mind - BrainHQ Cognitive Training Intervention | Change in Insulin-like Growth Factor 1 (IGF-1) From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 72 weeks | 7.55 square root transformed pg/mL | Standard Error 5.93 |
| Mind - BrainHQ Cognitive Training Intervention | Change in Insulin-like Growth Factor 1 (IGF-1) From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 24 weeks | 3.37 square root transformed pg/mL | Standard Error 5.92 |
| Mind - BrainHQ Cognitive Training Intervention | Change in Insulin-like Growth Factor 1 (IGF-1) From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 48 weeks | 3.25 square root transformed pg/mL | Standard Error 6.05 |
| Move - Lifestyle Physical Activity Intervention | Change in Insulin-like Growth Factor 1 (IGF-1) From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 72 weeks | 4.07 square root transformed pg/mL | Standard Error 5.75 |
| Move - Lifestyle Physical Activity Intervention | Change in Insulin-like Growth Factor 1 (IGF-1) From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 48 weeks | 4.24 square root transformed pg/mL | Standard Error 5.79 |
| Move - Lifestyle Physical Activity Intervention | Change in Insulin-like Growth Factor 1 (IGF-1) From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 24 weeks | 5.26 square root transformed pg/mL | Standard Error 5.65 |
| MindMoves - Cognitive Training and Lifestyle Physical Activity | Change in Insulin-like Growth Factor 1 (IGF-1) From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 24 weeks | 6.59 square root transformed pg/mL | Standard Error 5.88 |
| MindMoves - Cognitive Training and Lifestyle Physical Activity | Change in Insulin-like Growth Factor 1 (IGF-1) From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 48 weeks | 6.40 square root transformed pg/mL | Standard Error 6.05 |
| MindMoves - Cognitive Training and Lifestyle Physical Activity | Change in Insulin-like Growth Factor 1 (IGF-1) From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 72 weeks | -4.42 square root transformed pg/mL | Standard Error 5.97 |
| Usual Care | Change in Insulin-like Growth Factor 1 (IGF-1) From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 72 weeks | 2.71 square root transformed pg/mL | Standard Error 5.89 |
| Usual Care | Change in Insulin-like Growth Factor 1 (IGF-1) From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 24 weeks | 8.45 square root transformed pg/mL | Standard Error 5.85 |
| Usual Care | Change in Insulin-like Growth Factor 1 (IGF-1) From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 48 weeks | -1.52 square root transformed pg/mL | Standard Error 5.89 |
Comparison: Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over timep-value: 0.798Mixed Models Analysis
Comparison: Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over timep-value: 0.461Mixed Models Analysis
Comparison: Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over timep-value: 0.419Mixed Models Analysis
Secondary
Change in Self-reported Cognitive Activity From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
Self-report cognitive activity is a self-report questionnaire of participation in nine activities that involve information processing with minimal physical or social demands. Participants rate on a five-point scale. The score is an average of nine items (minimum score of 9, maximum score of 54 with higher scores indicating higher self-reported levels of cognitive activity).
Time frame: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mind - BrainHQ Cognitive Training Intervention | Change in Self-reported Cognitive Activity From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 72 weeks | -.10 score on a scale | Standard Error 0.07 |
| Mind - BrainHQ Cognitive Training Intervention | Change in Self-reported Cognitive Activity From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 24 weeks | .03 score on a scale | Standard Error 0.07 |
| Mind - BrainHQ Cognitive Training Intervention | Change in Self-reported Cognitive Activity From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 48 weeks | .01 score on a scale | Standard Error 0.07 |
| Move - Lifestyle Physical Activity Intervention | Change in Self-reported Cognitive Activity From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 72 weeks | .21 score on a scale | Standard Error 0.07 |
| Move - Lifestyle Physical Activity Intervention | Change in Self-reported Cognitive Activity From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 48 weeks | .21 score on a scale | Standard Error 0.07 |
| Move - Lifestyle Physical Activity Intervention | Change in Self-reported Cognitive Activity From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 24 weeks | .15 score on a scale | Standard Error 0.07 |
| MindMoves - Cognitive Training and Lifestyle Physical Activity | Change in Self-reported Cognitive Activity From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 24 weeks | .08 score on a scale | Standard Error 0.07 |
| MindMoves - Cognitive Training and Lifestyle Physical Activity | Change in Self-reported Cognitive Activity From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 48 weeks | -.04 score on a scale | Standard Error 0.07 |
| MindMoves - Cognitive Training and Lifestyle Physical Activity | Change in Self-reported Cognitive Activity From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 72 weeks | .12 score on a scale | Standard Error 0.07 |
| Usual Care | Change in Self-reported Cognitive Activity From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 72 weeks | .13 score on a scale | Standard Error 0.07 |
| Usual Care | Change in Self-reported Cognitive Activity From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 24 weeks | .02 score on a scale | Standard Error 0.07 |
| Usual Care | Change in Self-reported Cognitive Activity From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 48 weeks | .03 score on a scale | Standard Error 0.07 |
Comparison: Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over timep-value: 0.092Mixed Models Analysis
Comparison: Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over timep-value: 0.245Mixed Models Analysis
Comparison: Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over timep-value: 0.107Mixed Models Analysis
Secondary
Change in Self-reported Physical Activity as Assessed by the Community Healthy Activities Model Program for Seniors (CHAMPS) Survey From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
The Community Health Activities Model Program for Seniors (CHAMPS) is a 30-item self-report questionnaire that assesses the leisure time, household, and transportation physical activity in past two weeks. Participants are asked how long they participate in 30 different activities and at what frequency. Each activity is assigned intensity. Scores include mean minutes per week of light and moderate-vigorous physical activity for both leisure time and household scales (minimum score of 0 minutes and maximum score of 24 hours, with higher scores indicating more time spent in physical activity).
Time frame: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mind - BrainHQ Cognitive Training Intervention | Change in Self-reported Physical Activity as Assessed by the Community Healthy Activities Model Program for Seniors (CHAMPS) Survey From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 24 weeks | .36 log-transformed hours | Standard Error 0.11 |
| Mind - BrainHQ Cognitive Training Intervention | Change in Self-reported Physical Activity as Assessed by the Community Healthy Activities Model Program for Seniors (CHAMPS) Survey From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 72 weeks | .48 log-transformed hours | Standard Error 0.12 |
| Mind - BrainHQ Cognitive Training Intervention | Change in Self-reported Physical Activity as Assessed by the Community Healthy Activities Model Program for Seniors (CHAMPS) Survey From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 48 weeks | .40 log-transformed hours | Standard Error 0.11 |
| Move - Lifestyle Physical Activity Intervention | Change in Self-reported Physical Activity as Assessed by the Community Healthy Activities Model Program for Seniors (CHAMPS) Survey From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 24 weeks | .32 log-transformed hours | Standard Error 0.11 |
| Move - Lifestyle Physical Activity Intervention | Change in Self-reported Physical Activity as Assessed by the Community Healthy Activities Model Program for Seniors (CHAMPS) Survey From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 72 weeks | .46 log-transformed hours | Standard Error 0.11 |
| Move - Lifestyle Physical Activity Intervention | Change in Self-reported Physical Activity as Assessed by the Community Healthy Activities Model Program for Seniors (CHAMPS) Survey From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 48 weeks | .36 log-transformed hours | Standard Error 0.11 |
| MindMoves - Cognitive Training and Lifestyle Physical Activity | Change in Self-reported Physical Activity as Assessed by the Community Healthy Activities Model Program for Seniors (CHAMPS) Survey From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 48 weeks | .21 log-transformed hours | Standard Error 0.12 |
| MindMoves - Cognitive Training and Lifestyle Physical Activity | Change in Self-reported Physical Activity as Assessed by the Community Healthy Activities Model Program for Seniors (CHAMPS) Survey From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 24 weeks | .21 log-transformed hours | Standard Error 0.11 |
| MindMoves - Cognitive Training and Lifestyle Physical Activity | Change in Self-reported Physical Activity as Assessed by the Community Healthy Activities Model Program for Seniors (CHAMPS) Survey From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 72 weeks | .45 log-transformed hours | Standard Error 0.12 |
| Usual Care | Change in Self-reported Physical Activity as Assessed by the Community Healthy Activities Model Program for Seniors (CHAMPS) Survey From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 24 weeks | .26 log-transformed hours | Standard Error 0.11 |
| Usual Care | Change in Self-reported Physical Activity as Assessed by the Community Healthy Activities Model Program for Seniors (CHAMPS) Survey From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 72 weeks | .44 log-transformed hours | Standard Error 0.11 |
| Usual Care | Change in Self-reported Physical Activity as Assessed by the Community Healthy Activities Model Program for Seniors (CHAMPS) Survey From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 48 weeks | .28 log-transformed hours | Standard Error 0.11 |
Comparison: Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over timep-value: 0.995Mixed Models Analysis
Comparison: Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over timep-value: 0.946Mixed Models Analysis
Comparison: Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over timep-value: 0.593Mixed Models Analysis
Secondary
Change in the Two-minute Step Test of Aerobic Fitness Score From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
This is a test of aerobic fitness that can be performed in a small space using minimal equipment. Participants step in place to a predesignated height for two minutes. This test is correlated with treadmill tests of aerobic fitness. The score is number of valid steps achieved reaching the predesignated height in two minutes.
Time frame: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mind - BrainHQ Cognitive Training Intervention | Change in the Two-minute Step Test of Aerobic Fitness Score From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 24 weeks | -3.52 steps | Standard Error 2.38 |
| Mind - BrainHQ Cognitive Training Intervention | Change in the Two-minute Step Test of Aerobic Fitness Score From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 72 weeks | -5.42 steps | Standard Error 2.42 |
| Mind - BrainHQ Cognitive Training Intervention | Change in the Two-minute Step Test of Aerobic Fitness Score From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 48 weeks | -3.33 steps | Standard Error 2.44 |
| Move - Lifestyle Physical Activity Intervention | Change in the Two-minute Step Test of Aerobic Fitness Score From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 24 weeks | -2.71 steps | Standard Error 2.27 |
| Move - Lifestyle Physical Activity Intervention | Change in the Two-minute Step Test of Aerobic Fitness Score From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 72 weeks | -2.15 steps | Standard Error 2.31 |
| Move - Lifestyle Physical Activity Intervention | Change in the Two-minute Step Test of Aerobic Fitness Score From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 48 weeks | -2.33 steps | Standard Error 2.31 |
| MindMoves - Cognitive Training and Lifestyle Physical Activity | Change in the Two-minute Step Test of Aerobic Fitness Score From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 48 weeks | -5.64 steps | Standard Error 2.42 |
| MindMoves - Cognitive Training and Lifestyle Physical Activity | Change in the Two-minute Step Test of Aerobic Fitness Score From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 24 weeks | -2.69 steps | Standard Error 2.34 |
| MindMoves - Cognitive Training and Lifestyle Physical Activity | Change in the Two-minute Step Test of Aerobic Fitness Score From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 72 weeks | -7.04 steps | Standard Error 2.34 |
| Usual Care | Change in the Two-minute Step Test of Aerobic Fitness Score From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 24 weeks | -5.10 steps | Standard Error 2.35 |
| Usual Care | Change in the Two-minute Step Test of Aerobic Fitness Score From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 72 weeks | -5.16 steps | Standard Error 2.33 |
| Usual Care | Change in the Two-minute Step Test of Aerobic Fitness Score From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 48 weeks | -9.46 steps | Standard Error 2.32 |
Comparison: Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over timep-value: 0.38Mixed Models Analysis
Comparison: Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over timep-value: 0.759Mixed Models Analysis
Comparison: Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over timep-value: 0.219Mixed Models Analysis
Secondary
Change in Vascular Endothelial Growth Factor A (VEGF) Levels From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
We will obtain blood samples for VEGF. Pretreatment serum or plasma specimens will be prepared using standard techniques and archived at -80°C in aliquots with no specimen subjected to more than two freeze-thaw cycles. All assays performed in a blinded fashion and according to manufacturer's protocol using a 384-well modified method. Luminex FlexMAP 3D will be used with concentrations calculated based on 7-pt standard curves using a 5-parametric fit algorithm in xPONENT v4.0.3. Following recommendations, serum biomarkers will be obtained in the morning (8am-10am) following an 8-hour fast.
Time frame: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mind - BrainHQ Cognitive Training Intervention | Change in Vascular Endothelial Growth Factor A (VEGF) Levels From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 24 weeks | .02 log-transformed pg/mL | Standard Error 0.03 |
| Mind - BrainHQ Cognitive Training Intervention | Change in Vascular Endothelial Growth Factor A (VEGF) Levels From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 72 weeks | .02 log-transformed pg/mL | Standard Error 0.03 |
| Mind - BrainHQ Cognitive Training Intervention | Change in Vascular Endothelial Growth Factor A (VEGF) Levels From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 48 weeks | .06 log-transformed pg/mL | Standard Error 0.03 |
| Move - Lifestyle Physical Activity Intervention | Change in Vascular Endothelial Growth Factor A (VEGF) Levels From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 24 weeks | .03 log-transformed pg/mL | Standard Error 0.03 |
| Move - Lifestyle Physical Activity Intervention | Change in Vascular Endothelial Growth Factor A (VEGF) Levels From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 72 weeks | -.03 log-transformed pg/mL | Standard Error 0.03 |
| Move - Lifestyle Physical Activity Intervention | Change in Vascular Endothelial Growth Factor A (VEGF) Levels From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 48 weeks | .00 log-transformed pg/mL | Standard Error 0.03 |
| MindMoves - Cognitive Training and Lifestyle Physical Activity | Change in Vascular Endothelial Growth Factor A (VEGF) Levels From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 48 weeks | .03 log-transformed pg/mL | Standard Error 0.03 |
| MindMoves - Cognitive Training and Lifestyle Physical Activity | Change in Vascular Endothelial Growth Factor A (VEGF) Levels From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 24 weeks | -.05 log-transformed pg/mL | Standard Error 0.03 |
| MindMoves - Cognitive Training and Lifestyle Physical Activity | Change in Vascular Endothelial Growth Factor A (VEGF) Levels From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 72 weeks | .03 log-transformed pg/mL | Standard Error 0.03 |
| Usual Care | Change in Vascular Endothelial Growth Factor A (VEGF) Levels From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 24 weeks | .00 log-transformed pg/mL | Standard Error 0.03 |
| Usual Care | Change in Vascular Endothelial Growth Factor A (VEGF) Levels From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 72 weeks | -.03 log-transformed pg/mL | Standard Error 0.03 |
| Usual Care | Change in Vascular Endothelial Growth Factor A (VEGF) Levels From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks | Change from baseline to 48 weeks | .03 log-transformed pg/mL | Standard Error 0.03 |
Comparison: Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over timep-value: 0.371Mixed Models Analysis
Comparison: Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over timep-value: 0.633Mixed Models Analysis
Comparison: Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over timep-value: 0.23Mixed Models Analysis
Other Pre-specified
Apolipoprotein [APOE]- ε4 Allele
Potential moderator. Candidate gene analysis with DNA extraction from whole blood samples using an Autogen DNA isolation kit (Qiagen, Venlo, Netherlands). Participants will be characterized by APOE genotype and subdivided into two groups of patients in whom the APOE ε4 allele was absent or present.
Time frame: Baseline
Population: The number of participants analyzed represents the total of number of participants for whom blood was drawn and successfully analyzed to determine APOE genotype.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mind - BrainHQ Cognitive Training Intervention | Apolipoprotein [APOE]- ε4 Allele | Count of participants with APOE ε4 allele present | 10 Participants |
| Mind - BrainHQ Cognitive Training Intervention | Apolipoprotein [APOE]- ε4 Allele | Count of participants with APOE ε4 allele absent | 50 Participants |
| Move - Lifestyle Physical Activity Intervention | Apolipoprotein [APOE]- ε4 Allele | Count of participants with APOE ε4 allele present | 16 Participants |
| Move - Lifestyle Physical Activity Intervention | Apolipoprotein [APOE]- ε4 Allele | Count of participants with APOE ε4 allele absent | 44 Participants |
| MindMoves - Cognitive Training and Lifestyle Physical Activity | Apolipoprotein [APOE]- ε4 Allele | Count of participants with APOE ε4 allele absent | 45 Participants |
| MindMoves - Cognitive Training and Lifestyle Physical Activity | Apolipoprotein [APOE]- ε4 Allele | Count of participants with APOE ε4 allele present | 18 Participants |
| Usual Care | Apolipoprotein [APOE]- ε4 Allele | Count of participants with APOE ε4 allele absent | 45 Participants |
| Usual Care | Apolipoprotein [APOE]- ε4 Allele | Count of participants with APOE ε4 allele present | 18 Participants |
Other Pre-specified
Brain-derived Neurotrophic Factor (BDNF) Val66Met Polymorphism
Potential moderator. Val66Met polymorphism in the BDNF gene assessed using candidate genotyping. The BDNF gene locus is located on Chromosome 11. BDNF Met positive genotypes are heterozygous Val/Met or homozygous Met/Met. Results will be reported as presence of Met allele or absence of Met allele
Time frame: Baseline
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mind - BrainHQ Cognitive Training Intervention | Brain-derived Neurotrophic Factor (BDNF) Val66Met Polymorphism | Met allele present | 17 Participants |
| Mind - BrainHQ Cognitive Training Intervention | Brain-derived Neurotrophic Factor (BDNF) Val66Met Polymorphism | Met allele absent | 47 Participants |
| Move - Lifestyle Physical Activity Intervention | Brain-derived Neurotrophic Factor (BDNF) Val66Met Polymorphism | Met allele absent | 52 Participants |
| Move - Lifestyle Physical Activity Intervention | Brain-derived Neurotrophic Factor (BDNF) Val66Met Polymorphism | Met allele present | 9 Participants |
| MindMoves - Cognitive Training and Lifestyle Physical Activity | Brain-derived Neurotrophic Factor (BDNF) Val66Met Polymorphism | Met allele present | 18 Participants |
| MindMoves - Cognitive Training and Lifestyle Physical Activity | Brain-derived Neurotrophic Factor (BDNF) Val66Met Polymorphism | Met allele absent | 46 Participants |
| Usual Care | Brain-derived Neurotrophic Factor (BDNF) Val66Met Polymorphism | Met allele present | 9 Participants |
| Usual Care | Brain-derived Neurotrophic Factor (BDNF) Val66Met Polymorphism | Met allele absent | 55 Participants |
Other Pre-specified
Level and Change in Center for Epidemiologic Studies-Depression Scale Score From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks.
Depressive symptoms will be evaluated as a potential moderator. The Center for Epidemiologic Studies-Depression Scale (20 items scored 0-3) assesses symptoms of depressed mood, feelings of guilt and worthlessness, feelings of helplessness and hopelessness, psychomotor retardation, loss of appetite, and sleep disturbance. Participants who score ≥ 16 will be referred to their primary/ psychiatric provider for further evaluation and treatment. Scores range from 0-60, with higher score indicating more depressive symptoms.
Time frame: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mind - BrainHQ Cognitive Training Intervention | Level and Change in Center for Epidemiologic Studies-Depression Scale Score From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks. | Change from baseline to 24 weeks | -.07 log-transformed score on a scale | Standard Error 0.11 |
| Mind - BrainHQ Cognitive Training Intervention | Level and Change in Center for Epidemiologic Studies-Depression Scale Score From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks. | Change from baseline to 72 weeks | .02 log-transformed score on a scale | Standard Error 0.11 |
| Mind - BrainHQ Cognitive Training Intervention | Level and Change in Center for Epidemiologic Studies-Depression Scale Score From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks. | Change from baseline to 48 weeks | -.18 log-transformed score on a scale | Standard Error 0.11 |
| Move - Lifestyle Physical Activity Intervention | Level and Change in Center for Epidemiologic Studies-Depression Scale Score From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks. | Change from baseline to 24 weeks | .09 log-transformed score on a scale | Standard Error 0.11 |
| Move - Lifestyle Physical Activity Intervention | Level and Change in Center for Epidemiologic Studies-Depression Scale Score From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks. | Change from baseline to 72 weeks | -.08 log-transformed score on a scale | Standard Error 0.11 |
| Move - Lifestyle Physical Activity Intervention | Level and Change in Center for Epidemiologic Studies-Depression Scale Score From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks. | Change from baseline to 48 weeks | -.07 log-transformed score on a scale | Standard Error 0.11 |
| MindMoves - Cognitive Training and Lifestyle Physical Activity | Level and Change in Center for Epidemiologic Studies-Depression Scale Score From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks. | Change from baseline to 48 weeks | -.05 log-transformed score on a scale | Standard Error 0.11 |
| MindMoves - Cognitive Training and Lifestyle Physical Activity | Level and Change in Center for Epidemiologic Studies-Depression Scale Score From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks. | Change from baseline to 24 weeks | .00 log-transformed score on a scale | Standard Error 0.11 |
| MindMoves - Cognitive Training and Lifestyle Physical Activity | Level and Change in Center for Epidemiologic Studies-Depression Scale Score From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks. | Change from baseline to 72 weeks | -.24 log-transformed score on a scale | Standard Error 0.11 |
| Usual Care | Level and Change in Center for Epidemiologic Studies-Depression Scale Score From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks. | Change from baseline to 24 weeks | .16 log-transformed score on a scale | Standard Error 0.11 |
| Usual Care | Level and Change in Center for Epidemiologic Studies-Depression Scale Score From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks. | Change from baseline to 72 weeks | .00 log-transformed score on a scale | Standard Error 0.11 |
| Usual Care | Level and Change in Center for Epidemiologic Studies-Depression Scale Score From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks. | Change from baseline to 48 weeks | .07 log-transformed score on a scale | Standard Error 0.11 |
Comparison: Statistical Test 1: Main effect of Mind (MindMoves + Mind vs. Move + Usual Care) for change over timep-value: 0.491Mixed Models Analysis
Comparison: Statistical Test 2: Main effect of Move (MindMoves + Move vs. Mind + Usual Care) for change over timep-value: 0.444Mixed Models Analysis
Comparison: Statistical Test 3: Interaction effect of Mind x Move (MindMoves + Usual Care vs. Mind + Move) for change over timep-value: 0.279Mixed Models Analysis