AIDS, Cardiovascular Disease, HIV
Conditions
Brief summary
The purpose of this study is to see if exercise is helpful for improving memory, concentration thinking abilities, physical function, and quality of life for adults aged 50 to 89 years living with HIV and who have two or more cardiovascular disease risk factors. The study will test two kinds of intervention exercises: one group will walk for exercise and the second group will stretch for exercise. Members of both interventions will be asked to participate in one-on-one interviews/assessments, measures of physical functioning, and some sessions with others who are also enrolled in the study.
Detailed description
This is a two arm, randomized controlled trial to test the longitudinal effects of the Let's Move Program (walking for exercise) compared to effects of the attention control Let's Flex Program (stretching for exercise) in participants aged 50 to 89 years living with HIV and who have two or more cardiovascular disease risk factors. Participants in both interventions will be asked to participate in one-on-one interviews/assessments, measures of physical functioning, and some sessions with others who are also enrolled in the study. Participants will participate in an in home exercise program for twelve weeks in which the study team will help identify maximum duration and intensity followed by a maintenance period for weeks 13-58.
Interventions
BEHAVIORALLet's Move Program
Participants will be asked to walk five times per week for twelve weeks for a minimum of 30 minutes while wearing a heart rate monitor and a pedometer. Participants will also receive weekly telephone calls from a member of the research team to monitor walking progress and to change walking duration or intensity level based on their progress.After the twelve week period, participants will enter a maintenance exercise phase for weeks 13-17 in which they will be asked to maintain their exercise regimen.
BEHAVIORALLet's Flex Program
Participants will be asked to stretch five times per week for twelve weeks for a minimum of 30 minutes. Participants will also receive weekly telephone calls from a member of the research team to monitor progress and to change duration or intensity level based on their progress.After the twelve week period, participants will enter a maintenance exercise phase for weeks 13-17 in which they will be asked to maintain their exercise regimen.
BEHAVIORALGroup Motivational Interviewing
Participants will attend four separate group intervention sessions for 2.5 hours for four consecutive weeks at the beginning of the program. Groups will consist of 6-8 members and will focus on the rationale for aerobic exercise, barriers to exercise, finding time for exercise, how to set short and long term exercise goals, and use of self-monitoring to improve exercise engagement.
Sponsors
National Institute of Nursing Research (NINR)
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* HIV diagnosis * English speaking * Live independently within a 30-45 mile radius of Atlanta, Georgia * Not involved in any structured exercise program or exercising 3 or more times per week for a minimum of 30 minutes * Not involved in any weight loss program * Not hospitalized within the last 60-days * Clinically stable and on antiretroviral therapy (ART) 6 months before enrollment * If taking statins, stable on medication for 3 months * Score 3 or less on the verbal memory subtest of the Montreal Cognitive Assessment (MoCA) * Less than 0.5 standard deviations (SD) below mean on the Oral Trail Making Test B * Able to provide informed consent and pass a consent post-test
Exclusion criteria
* Non sedentary (defined as engaging in \> 30 minutes of moderately strenuous exercise 3 times or more a week) * Medical or physical condition that would preclude participation in the exercise component of the study (e.g., severe arthritis or mobility problems, lower extremity amputations, joint replacement(s), balance disorders, dizziness, dyspnea on exertion (DOE) with moderate exertion, difficulty walking one block, recent falls, obvious injury to lower extremity, uncontrolled hypertension or diabetes, renal failure, blindness, or a history of angina with activity) * Ischemic changes or inappropriate BP changes on baseline exercise (modified Balke or Bruce) treadmill test * On oral corticosteroids (nasal, optical and inhaler corticosteroids allowed without restriction) , experiencing acute inflammation at time of baseline or follow-up testing (this will result in rescheduling of testing if no other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NIH Toolbox | Baseline, Post Intervention (Up to 58 weeks) | Computerized cognitive tests developed and distributed by the NIH. Tests include Pattern Comparison Processing Speed Test, Picture Vocabulary Test, Reading Recognition Test, Dimensional Change Card Sort Test, Flanker Inhibitory Control and Attention Test, Picture Sequence Memory Test, List Sorting Working Memory Test, and Oral Symbol Digit Test |
| Letter Fluency Assessed by Change in FAS Test Score | Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline) | The FAS test requires stating out loud as many words that begin with the assigned letter (F, A, and S) as possible within 60-seconds. Results represent total number of words stated for F,A & S combined. |
| Category Fluency Test Score | Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline) | The category fluency test requires participants to state out load the names of as many animals as possible within 60-seconds. Results are total number of animals named. |
| Hopkins Verbal Learning Test (HVLT) - Revised Score | Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline) | The HVLT-Revised is a list learning task requiring the respondent to recall as many words as possible from a list of 12 words provided orally by the examiner. There is a learning trial, a delayed recall trial, and a recognition trial. Results show HVLT Total recall (Total number if words recalled over 3 trials) and HVLT Delayed recall (Total number of words recalled after 25 minute delay). |
| Brief Visual Memory Test - Revised (BVMT-R) Score | Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline) | The Brief Visual Memory Test is a performance based test that requires that participants reproduce simple visual images from memory (the images are displayed for 10 seconds then removed from view). The BVMT-R contains a learning trial, a recall trial, a recognition trial, and a copy trial. Each figure recalled is given 0,1, or 2 points based on accuracy and location recall. Results show BVMT Total recall (Total number if figures recalled over 3 trials: range 0 - 36) and BVMT delayed recall (total number of figures recalled after 25 min delay. Score range 0-12). Higher score correlate with better outcome. |
| Grooved Pegboard Test Score | Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline) | The Grooved Pegboard Test requires the placing of grooved pegs into a same-shaped hole as quickly as possible, once with the dominant hand and once with the non-dominant hand. |
| Finger Tapping Test Score | Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline) | The finger tapping test a fine motor speed requires tapping a lever with the index finger as quickly as possible. Trials with the dominant and non-dominant hand are completed. |
| Coding Test Score | Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline) | The coding test requires writing the corresponding symbol associated with a letter from a key provided. As many responses as possible are completed in the 120 second time limit. Results presented are the total number of correct responses (possible score range 0-135). |
| Digit Span Test Score | Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline) | The digit span test is a performance based test that requires repeating an increasing span of digits that are provided verbally by the examiner. The test includes trials of repeating digits in the same order presented by the examiner, in the reverse order of that presented by the examiner, and in ascending sequence. Scores range from 0 to 48. Higher score correlates with better outcome. |
| Symbol Span Test Score | Baseline, 3 months, 6 months and 12 months Post Intervention | The subtest assesses visual working memory using novel visual stimuli. A series of abstract symbols on a page are shown briefly. Then the symbols are to be selected from an array of symbols in the same order they were presented on the previous page. This performance based test measures storage and manipulation of visual details in working memory. Score range from 0-36. Higher score correlates with better outcome. |
| Instrumental Activities of Daily Living (IADL) Test Score | Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 (56-58 weeks post baseline) | The Instrumental Activities of Daily Living (IADL) Test is a self-report measure assessing the amount of assistance, if any, required to do day-to-day tasks necessary to live independently. A summary score ranges from 0 (low function, dependent) to 8 (high function, independent) for women and 0 through 5 for men to avoid potential gender bias). Higher scores indicate worse performance in instrumental activities activities of daily living. |
| Stroop Color and Word Test Score | Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline) | The Stroop Color and Word Test is a performance-based test of executive function and inhibitory responding. The participant is presented with a page with the words red, blue, and green printed 100 times in (20 words in 5 columns). Each word is printed in a different color of ink than the target word (e.g, the word red is printed in blue ink). Participants read the color of ink in which the word is printed as quickly are possible within a time limit. The correct number within the time limit is the score. Raw scores (unadjusted for age and education) range from 0-100. |
| Trail Making Test Score | Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline) | The Trail Making Test is a performance based test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect circles as possible while still maintaining accuracy. Trails A subtest requires the connection in sequence of 25 circles labeled by numbers. Trails B requires the connection in sequence of 25 circles labeled by alternating numbers and letters (1-A-2-B-3-C). The score on the test is the time in seconds that it takes to complete. Higher scores (i.e., time) indicate poorer performance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Interleukin 6 (IL-6) Level | Baseline, T1 (13-15 Weeks), T2 (28-30 weeks), T3 (56-58 weeks) | IL-6 is a pro-inflammatory cytokine known to contribute to the pathogenesis of risk of cardiovascular disease (CVD) and cognitive impairment (CI) through inflammation and promotion of endothelial vascular dysfunction. IL-6 is measured by enzyme-linked immunosorbent assay (ELISA) and reported as in picograms per deciliter (pg/dL). Higher concentrations of IL-6 raise congenital heart defect risk. |
| Tumor Necrosis Factor Alpha (TNF-alpha) Level | Baseline, T1 (13-15 wks), T2 (28-30 wks), T3 (56-58 wks) | TNFR1 membrane bound receptors that have been shown to bind TNF alpha. Activation of TNFR1 mediates the proinflammatory properties of TNF alpha. |
| Brain-derived Neurotrophic Factor (BDNF) Level | Baseline, Post Intervention (Up to 58 weeks) | BDNF is a protein that occurs naturally in the hippocampus, cortex, and basal forebrain-areas vital to learning, memory, and higher thinking; an increase in BDNF in animal models and humans is thought to enhance neurogenesis. BDNF is reported as in picogram per milliliter (pg/mL). |
| Flow-Mediated Dilatation (FMD) | Baseline, T2 (28-30 weeks post baseline) | Flow-mediated dilatation (FMD) is a measure of endothelial function; the measure of % FMD at 60 seconds reflects arterial relaxation time after cuff deflation. |
| Soluble Cluster of Differentiation 14 (sCD14) Level | Baseline, T1 (13-15 weeks), T2 (28-30 weeks), T3 (56 -58 weeks) | Soluble Cluster of Differentiation 14 (sCD14) is a marker of monocyte activation, is associated with neurocognitive impairment and HIV-associated neurocognitive disorders (HANDs) and higher mortality in persons living with HIV. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pittsburgh Sleep Quality Index (PSQI) Score | Baseline, T2 (28-30 weeks post baseline), T3 (56-58 weeks post baseline) | The Pittsburgh Sleep Quality Index (PSQI) is a 19-item measure of the quality and patterns of sleep among adults. Scoring is based on a 0 to 3 Likert scale. The global score is 21; total possible score ranges from 0 to 21. The higher the score the worse the sleep quality. |
| Exercise Regimen as Assessed by the Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire | Baseline, T2 (28-30 weeks post baseline), T3 (56-58 weeks post baseline) | The 41-item Community Healthy Activities Model Program for Seniors evaluates weekly duration of various types of physical activity among older adults including light, moderate and vigorous intensity levels. The activity is assessed by hours per week using 6 categories less than 1 hour to 9 or more hours. The values presented below are hours participants indicated they spent in moderate intensity activity levels at the 3 time points over the past 4 weeks. Guidelines suggest 150 minutes (2.5 hours) per week in moderate intensity physical activity, below this number is considered sedentary. We measure change from baseline in time spent in moderate intensity exercise. |
| V02 Max Rate | Baseline | V02 max is the maximum rate of oxygen consumption as measured during incremental exercise using the Balke treadmill test. This is an exploratory outcome. |
| Six-minute Walk Test | Baseline, T2 (28-30 weeks post baseline), T3 (56-58 weeks post baseline) | Measure of functional capacity or submaximal exercise. Scores reflect distance walked in feet for 6 minutes duration. This is an exploratory outcome. |
| Beck Depression Inventory-II (BDI-II) Score | Baseline, T2 (28-30 weeks post baseline), T3 (56-58 weeks post baseline) | BDI-II is a 21-question multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depression. Each answer being scored on a scale value of 0 to 3. Scores range from 0-63. Interpretation: 0 through 9 indicate no or minimal depression; scores from 10 through 18 indicate mild to moderate depression; scores from 19 through 29 indicate moderate to severe depression; and scores from 30 through 63 indicate severe depression. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled between September 2016 and December 2018.
Participants by arm
| Arm | Count |
|---|---|
| Let's Move Program Participants in this group will be asked to walk five times per week for twelve weeks for a minimum of 30 minutes in their home while wearing a heart rate monitor and a pedometer. Participants will then enter a maintenance exercise period for 65 weeks.
Let's Move Program: Participants will be asked to walk five times per week for twelve weeks for a minimum of 30 minutes while wearing a heart rate monitor and a pedometer. Participants will also receive weekly telephone calls from a member of the research team to monitor walking progress and to change walking duration or intensity level based on their progress.After the twelve week period, participants will enter a maintenance exercise phase for weeks 13-17 in which they will be asked to maintain their exercise regimen.
Group Motivational Interviewing: Participants will attend four separate group intervention sessions for 2.5 hours for four consecutive weeks at the beginning of the program. Groups will consist of 6-8 members and will focus on the rationale for aerobic exercise, barriers to exercise, finding time for exercise, how to set short and long term exercise goals, and use of self-monitoring to improve exercise engagement. | 76 |
| Let's Flex Program Participants in this group will be asked to stretch five times per week for twelve weeks for a minimum of thirty minutes in their home. Participants will then enter a maintenance exercise period for 65 weeks.
Let's Flex Program: Participants will be asked to stretch five times per week for twelve weeks for a minimum of 30 minutes. Participants will also receive weekly telephone calls from a member of the research team to monitor progress and to change duration or intensity level based on their progress.After the twelve week period, participants will enter a maintenance exercise phase for weeks 13-17 in which they will be asked to maintain their exercise regimen.
Group Motivational Interviewing: Participants will attend four separate group intervention sessions for 2.5 hours for four consecutive weeks at the beginning of the program. Groups will consist of 6-8 members and will focus on the rationale for aerobic exercise, barriers to exercise, finding time for exercise, how to set short and long term exercise goals, and use of self-monitoring to improve exercise engagement. | 39 |
| Total | 115 |
Baseline characteristics
| Characteristic | Let's Flex Program | Total | Let's Move Program |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 4 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 38 Participants | 111 Participants | 73 Participants |
| Age, Continuous | 53.92 years STANDARD_DEVIATION 5.2 | 55.09 years STANDARD_DEVIATION 5.2 | 55.68 years STANDARD_DEVIATION 5.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 37 Participants | 100 Participants | 63 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 2 Participants | 12 Participants | 10 Participants |
| Region of Enrollment United States | 39 Participants | 115 Participants | 76 Participants |
| Sex: Female, Male Female | 20 Participants | 46 Participants | 26 Participants |
| Sex: Female, Male Male | 19 Participants | 69 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 76 | 0 / 39 |
| other Total, other adverse events | 0 / 76 | 0 / 39 |
| serious Total, serious adverse events | 0 / 76 | 0 / 39 |
Outcome results
Primary
Brief Visual Memory Test - Revised (BVMT-R) Score
The Brief Visual Memory Test is a performance based test that requires that participants reproduce simple visual images from memory (the images are displayed for 10 seconds then removed from view). The BVMT-R contains a learning trial, a recall trial, a recognition trial, and a copy trial. Each figure recalled is given 0,1, or 2 points based on accuracy and location recall. Results show BVMT Total recall (Total number if figures recalled over 3 trials: range 0 - 36) and BVMT delayed recall (total number of figures recalled after 25 min delay. Score range 0-12). Higher score correlate with better outcome.
Time frame: Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)
Population: Some participants did not complete the form or completed the incorrect forms and could not be included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Let's Move Program | Brief Visual Memory Test - Revised (BVMT-R) Score | Total recall - T2 (28-30 weeks post baseline) | 19.59 number of correct figures recalled | Standard Deviation 6.78 |
| Let's Move Program | Brief Visual Memory Test - Revised (BVMT-R) Score | Delayed recall - Baseline | 6.88 number of correct figures recalled | Standard Deviation 2.84 |
| Let's Move Program | Brief Visual Memory Test - Revised (BVMT-R) Score | Total recall - Baseline | 16.97 number of correct figures recalled | Standard Deviation 7.02 |
| Let's Move Program | Brief Visual Memory Test - Revised (BVMT-R) Score | Delayed recall - T1 ( 13-15 weeks post baseline) | 7.59 number of correct figures recalled | Standard Deviation 2.42 |
| Let's Move Program | Brief Visual Memory Test - Revised (BVMT-R) Score | Total recall - T3 ( 56-58 weeks post baseline) | 17.47 number of correct figures recalled | Standard Deviation 7.17 |
| Let's Move Program | Brief Visual Memory Test - Revised (BVMT-R) Score | Delayed recall - T2 (28-30 weeks post baseline) | 7.84 number of correct figures recalled | Standard Deviation 2.81 |
| Let's Move Program | Brief Visual Memory Test - Revised (BVMT-R) Score | Delayed recall - T3 ( 56-58 weeks post baseline) | 7.01 number of correct figures recalled | Standard Deviation 2.88 |
| Let's Move Program | Brief Visual Memory Test - Revised (BVMT-R) Score | Total recall - T1 ( 13-15 weeks post baseline) | 19.99 number of correct figures recalled | Standard Deviation 5.96 |
| Let's Flex Program | Brief Visual Memory Test - Revised (BVMT-R) Score | Delayed recall - T3 ( 56-58 weeks post baseline) | 6.29 number of correct figures recalled | Standard Deviation 3.25 |
| Let's Flex Program | Brief Visual Memory Test - Revised (BVMT-R) Score | Delayed recall - T2 (28-30 weeks post baseline) | 7.67 number of correct figures recalled | Standard Deviation 2.79 |
| Let's Flex Program | Brief Visual Memory Test - Revised (BVMT-R) Score | Total recall - Baseline | 15.97 number of correct figures recalled | Standard Deviation 4.2 |
| Let's Flex Program | Brief Visual Memory Test - Revised (BVMT-R) Score | Total recall - T1 ( 13-15 weeks post baseline) | 17.16 number of correct figures recalled | Standard Deviation 4.59 |
| Let's Flex Program | Brief Visual Memory Test - Revised (BVMT-R) Score | Total recall - T2 (28-30 weeks post baseline) | 18.18 number of correct figures recalled | Standard Deviation 5.69 |
| Let's Flex Program | Brief Visual Memory Test - Revised (BVMT-R) Score | Total recall - T3 ( 56-58 weeks post baseline) | 16.23 number of correct figures recalled | Standard Deviation 7.36 |
| Let's Flex Program | Brief Visual Memory Test - Revised (BVMT-R) Score | Delayed recall - Baseline | 6.51 number of correct figures recalled | Standard Deviation 2.58 |
| Let's Flex Program | Brief Visual Memory Test - Revised (BVMT-R) Score | Delayed recall - T1 ( 13-15 weeks post baseline) | 6.77 number of correct figures recalled | Standard Deviation 2.03 |
Primary
Category Fluency Test Score
The category fluency test requires participants to state out load the names of as many animals as possible within 60-seconds. Results are total number of animals named.
Time frame: Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)
Population: Some participants did not complete the form or completed the incorrect forms and could not be included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Let's Move Program | Category Fluency Test Score | T3 (56-58 weeks post baseline) | 19.22 Number of correct animals named | Standard Deviation 4.7 |
| Let's Move Program | Category Fluency Test Score | T2 (28-30 weeks post baseline) | 20.24 Number of correct animals named | Standard Deviation 4.38 |
| Let's Move Program | Category Fluency Test Score | Baseline | 19.97 Number of correct animals named | Standard Deviation 4.96 |
| Let's Move Program | Category Fluency Test Score | T1 (13-15 weeks post baseline) | 19.87 Number of correct animals named | Standard Deviation 4.35 |
| Let's Flex Program | Category Fluency Test Score | T1 (13-15 weeks post baseline) | 17.63 Number of correct animals named | Standard Deviation 6.59 |
| Let's Flex Program | Category Fluency Test Score | Baseline | 18.89 Number of correct animals named | Standard Deviation 6.03 |
| Let's Flex Program | Category Fluency Test Score | T2 (28-30 weeks post baseline) | 17.82 Number of correct animals named | Standard Deviation 6.26 |
| Let's Flex Program | Category Fluency Test Score | T3 (56-58 weeks post baseline) | 17.13 Number of correct animals named | Standard Deviation 5.53 |
Primary
Coding Test Score
The coding test requires writing the corresponding symbol associated with a letter from a key provided. As many responses as possible are completed in the 120 second time limit. Results presented are the total number of correct responses (possible score range 0-135).
Time frame: Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)
Population: The number analyzed includes participants who were able to complete each study visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Let's Move Program | Coding Test Score | Baseline | 46.07 number of correct responses | Standard Deviation 14.64 |
| Let's Move Program | Coding Test Score | T1 (13-15 weeks post baseline) | 45.31 number of correct responses | Standard Deviation 16.14 |
| Let's Move Program | Coding Test Score | T2 (28-30 weeks post baseline) | 47.89 number of correct responses | Standard Deviation 17.32 |
| Let's Move Program | Coding Test Score | T3 (56-58 weeks post baseline) | 50.11 number of correct responses | Standard Deviation 16.41 |
| Let's Flex Program | Coding Test Score | T3 (56-58 weeks post baseline) | 47.23 number of correct responses | Standard Deviation 14.93 |
| Let's Flex Program | Coding Test Score | Baseline | 45.69 number of correct responses | Standard Deviation 15.44 |
| Let's Flex Program | Coding Test Score | T2 (28-30 weeks post baseline) | 42.84 number of correct responses | Standard Deviation 15.19 |
| Let's Flex Program | Coding Test Score | T1 (13-15 weeks post baseline) | 43.13 number of correct responses | Standard Deviation 14.58 |
Primary
Digit Span Test Score
The digit span test is a performance based test that requires repeating an increasing span of digits that are provided verbally by the examiner. The test includes trials of repeating digits in the same order presented by the examiner, in the reverse order of that presented by the examiner, and in ascending sequence. Scores range from 0 to 48. Higher score correlates with better outcome.
Time frame: Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)
Population: The number analyzed includes participants who were able to complete each study visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Let's Move Program | Digit Span Test Score | T3 ( 56-58 weeks post baseline) | 23.86 number of correct digits | Standard Deviation 6.32 |
| Let's Move Program | Digit Span Test Score | T1 (13-15 weeks post baseline) | 24.32 number of correct digits | Standard Deviation 5.16 |
| Let's Move Program | Digit Span Test Score | Baseline | 23.19 number of correct digits | Standard Deviation 5.63 |
| Let's Move Program | Digit Span Test Score | T2 (28-30 weeks post baseline) | 23.86 number of correct digits | Standard Deviation 6.62 |
| Let's Flex Program | Digit Span Test Score | Baseline | 21.67 number of correct digits | Standard Deviation 5.56 |
| Let's Flex Program | Digit Span Test Score | T3 ( 56-58 weeks post baseline) | 21.27 number of correct digits | Standard Deviation 5.56 |
| Let's Flex Program | Digit Span Test Score | T2 (28-30 weeks post baseline) | 21.76 number of correct digits | Standard Deviation 5.84 |
| Let's Flex Program | Digit Span Test Score | T1 (13-15 weeks post baseline) | 22.41 number of correct digits | Standard Deviation 4.72 |
Primary
Finger Tapping Test Score
The finger tapping test a fine motor speed requires tapping a lever with the index finger as quickly as possible. Trials with the dominant and non-dominant hand are completed.
Time frame: Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)
Population: The number analyzed includes participants who were able to complete each study visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Let's Move Program | Finger Tapping Test Score | Dominant hand - Baseline | 36.21 Seconds | Standard Deviation 8.13 |
| Let's Move Program | Finger Tapping Test Score | Dominant hand -T1 ( 13-15 weeks post baseline) | 39.34 Seconds | Standard Deviation 10.47 |
| Let's Move Program | Finger Tapping Test Score | Dominant hand -T2 ( 28-30 weeks post baseline) | 38.19 Seconds | Standard Deviation 8.98 |
| Let's Move Program | Finger Tapping Test Score | Dominant hand -T2 ( 56-58 weeks post baseline) | 38.82 Seconds | Standard Deviation 9.57 |
| Let's Move Program | Finger Tapping Test Score | Nondominant hand - Baseline | 34.85 Seconds | Standard Deviation 8.29 |
| Let's Move Program | Finger Tapping Test Score | Nondominant hand -T1 ( 13-15 weeks post baseline) | 36.59 Seconds | Standard Deviation 8.32 |
| Let's Move Program | Finger Tapping Test Score | Nondominant hand -T2 ( 28-30 weeks post baseline) | 35.94 Seconds | Standard Deviation 8.05 |
| Let's Move Program | Finger Tapping Test Score | Nondominant hand -T2 ( 56-58 weeks post baseline) | 36.91 Seconds | Standard Deviation 8.36 |
| Let's Flex Program | Finger Tapping Test Score | Nondominant hand -T2 ( 56-58 weeks post baseline) | 31.94 Seconds | Standard Deviation 7.39 |
| Let's Flex Program | Finger Tapping Test Score | Dominant hand - Baseline | 32.83 Seconds | Standard Deviation 9.89 |
| Let's Flex Program | Finger Tapping Test Score | Nondominant hand - Baseline | 33.29 Seconds | Standard Deviation 10.09 |
| Let's Flex Program | Finger Tapping Test Score | Dominant hand -T1 ( 13-15 weeks post baseline) | 33.9 Seconds | Standard Deviation 11.37 |
| Let's Flex Program | Finger Tapping Test Score | Nondominant hand -T2 ( 28-30 weeks post baseline) | 34.53 Seconds | Standard Deviation 11.61 |
| Let's Flex Program | Finger Tapping Test Score | Dominant hand -T2 ( 28-30 weeks post baseline) | 34.31 Seconds | Standard Deviation 8.72 |
| Let's Flex Program | Finger Tapping Test Score | Nondominant hand -T1 ( 13-15 weeks post baseline) | 33.98 Seconds | Standard Deviation 9.51 |
| Let's Flex Program | Finger Tapping Test Score | Dominant hand -T2 ( 56-58 weeks post baseline) | 33.13 Seconds | Standard Deviation 6.92 |
Primary
Grooved Pegboard Test Score
The Grooved Pegboard Test requires the placing of grooved pegs into a same-shaped hole as quickly as possible, once with the dominant hand and once with the non-dominant hand.
Time frame: Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)
Population: The number analyzed includes participants who were able to complete each study visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Let's Move Program | Grooved Pegboard Test Score | Dominant Hand - Baseline | 100.26 Seconds | Standard Deviation 52.08 |
| Let's Move Program | Grooved Pegboard Test Score | Nondominant Hand - Baseline | 111.97 Seconds | Standard Deviation 48.88 |
| Let's Move Program | Grooved Pegboard Test Score | Dominant Hand -T2 (28-30 weeks post baseline) | 90.81 Seconds | Standard Deviation 32.85 |
| Let's Move Program | Grooved Pegboard Test Score | Nondominant Hand - T1 ( 13-15 weeks post baseline) | 110.63 Seconds | Standard Deviation 43.35 |
| Let's Move Program | Grooved Pegboard Test Score | Dominant Hand - T1 ( 13-15 weeks post baseline) | 91.49 Seconds | Standard Deviation 26.16 |
| Let's Move Program | Grooved Pegboard Test Score | Nondominant Hand -T2 (28-30 weeks post baseline) | 108.75 Seconds | Standard Deviation 50.43 |
| Let's Move Program | Grooved Pegboard Test Score | Dominant Hand -T3 (56-58 weeks post baseline) | 89.99 Seconds | Standard Deviation 34.03 |
| Let's Move Program | Grooved Pegboard Test Score | Nondominant Hand -T3 (56-58 weeks post baseline) | 101.04 Seconds | Standard Deviation 46.31 |
| Let's Flex Program | Grooved Pegboard Test Score | Dominant Hand -T3 (56-58 weeks post baseline) | 92.45 Seconds | Standard Deviation 29.37 |
| Let's Flex Program | Grooved Pegboard Test Score | Dominant Hand - Baseline | 103.46 Seconds | Standard Deviation 44.52 |
| Let's Flex Program | Grooved Pegboard Test Score | Dominant Hand - T1 ( 13-15 weeks post baseline) | 101.94 Seconds | Standard Deviation 30.38 |
| Let's Flex Program | Grooved Pegboard Test Score | Dominant Hand -T2 (28-30 weeks post baseline) | 101.78 Seconds | Standard Deviation 35.76 |
| Let's Flex Program | Grooved Pegboard Test Score | Nondominant Hand -T3 (56-58 weeks post baseline) | 112.5 Seconds | Standard Deviation 41.98 |
| Let's Flex Program | Grooved Pegboard Test Score | Nondominant Hand - Baseline | 118.67 Seconds | Standard Deviation 56.29 |
| Let's Flex Program | Grooved Pegboard Test Score | Nondominant Hand - T1 ( 13-15 weeks post baseline) | 120.42 Seconds | Standard Deviation 37.18 |
| Let's Flex Program | Grooved Pegboard Test Score | Nondominant Hand -T2 (28-30 weeks post baseline) | 119.06 Seconds | Standard Deviation 43.12 |
Primary
Hopkins Verbal Learning Test (HVLT) - Revised Score
The HVLT-Revised is a list learning task requiring the respondent to recall as many words as possible from a list of 12 words provided orally by the examiner. There is a learning trial, a delayed recall trial, and a recognition trial. Results show HVLT Total recall (Total number if words recalled over 3 trials) and HVLT Delayed recall (Total number of words recalled after 25 minute delay).
Time frame: Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)
Population: Some participants did not complete the form or completed the incorrect forms and could not be included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Let's Move Program | Hopkins Verbal Learning Test (HVLT) - Revised Score | Delayed recall - Baseline | 6.65 Number of correct words recalled | Standard Deviation 2.57 |
| Let's Move Program | Hopkins Verbal Learning Test (HVLT) - Revised Score | Total recall - Baseline | 6.65 Number of correct words recalled | Standard Deviation 2.57 |
| Let's Move Program | Hopkins Verbal Learning Test (HVLT) - Revised Score | Total recall - T1 ( 13-15 weeks post baseline) | 6.87 Number of correct words recalled | Standard Deviation 2.37 |
| Let's Move Program | Hopkins Verbal Learning Test (HVLT) - Revised Score | Total recall - T2 (28-30 weeks post baseline) | 6.56 Number of correct words recalled | Standard Deviation 2.68 |
| Let's Move Program | Hopkins Verbal Learning Test (HVLT) - Revised Score | Total recall - T3 ( 56-58 weeks post baseline) | 5.93 Number of correct words recalled | Standard Deviation 2.6 |
| Let's Move Program | Hopkins Verbal Learning Test (HVLT) - Revised Score | Delayed recall - T1 ( 13-15 weeks post baseline) | 6.87 Number of correct words recalled | Standard Deviation 2.37 |
| Let's Move Program | Hopkins Verbal Learning Test (HVLT) - Revised Score | Delayed recall - T2 (28-30 weeks post baseline) | 6.56 Number of correct words recalled | Standard Deviation 2.68 |
| Let's Move Program | Hopkins Verbal Learning Test (HVLT) - Revised Score | Delayed recall - T3 ( 56-58 weeks post baseline) | 5.93 Number of correct words recalled | Standard Deviation 2.6 |
| Let's Flex Program | Hopkins Verbal Learning Test (HVLT) - Revised Score | Delayed recall - T1 ( 13-15 weeks post baseline) | 6.65 Number of correct words recalled | Standard Deviation 2.17 |
| Let's Flex Program | Hopkins Verbal Learning Test (HVLT) - Revised Score | Delayed recall - T2 (28-30 weeks post baseline) | 7 Number of correct words recalled | Standard Deviation 2.25 |
| Let's Flex Program | Hopkins Verbal Learning Test (HVLT) - Revised Score | Total recall - T3 ( 56-58 weeks post baseline) | 6.35 Number of correct words recalled | Standard Deviation 2.68 |
| Let's Flex Program | Hopkins Verbal Learning Test (HVLT) - Revised Score | Total recall - Baseline | 6.46 Number of correct words recalled | Standard Deviation 2.4 |
| Let's Flex Program | Hopkins Verbal Learning Test (HVLT) - Revised Score | Delayed recall - Baseline | 6.46 Number of correct words recalled | Standard Deviation 2.4 |
| Let's Flex Program | Hopkins Verbal Learning Test (HVLT) - Revised Score | Total recall - T1 ( 13-15 weeks post baseline) | 6.65 Number of correct words recalled | Standard Deviation 2.17 |
| Let's Flex Program | Hopkins Verbal Learning Test (HVLT) - Revised Score | Delayed recall - T3 ( 56-58 weeks post baseline) | 6.35 Number of correct words recalled | Standard Deviation 2.68 |
| Let's Flex Program | Hopkins Verbal Learning Test (HVLT) - Revised Score | Total recall - T2 (28-30 weeks post baseline) | 7 Number of correct words recalled | Standard Deviation 2.25 |
Primary
Instrumental Activities of Daily Living (IADL) Test Score
The Instrumental Activities of Daily Living (IADL) Test is a self-report measure assessing the amount of assistance, if any, required to do day-to-day tasks necessary to live independently. A summary score ranges from 0 (low function, dependent) to 8 (high function, independent) for women and 0 through 5 for men to avoid potential gender bias). Higher scores indicate worse performance in instrumental activities activities of daily living.
Time frame: Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 (56-58 weeks post baseline)
Population: The number analyzed includes participants who were able to complete each study visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Let's Move Program | Instrumental Activities of Daily Living (IADL) Test Score | Baseline | 7.95 Score on a scale | Standard Deviation 0.19 |
| Let's Move Program | Instrumental Activities of Daily Living (IADL) Test Score | T1 (13-15 weeks post baseline) | 7.96 Score on a scale | Standard Deviation 0.24 |
| Let's Move Program | Instrumental Activities of Daily Living (IADL) Test Score | T2 (28-30 weeks post baseline) | 7.83 Score on a scale | Standard Deviation 0.65 |
| Let's Move Program | Instrumental Activities of Daily Living (IADL) Test Score | T3 (56-58 weeks post baseline) | 7.89 Score on a scale | Standard Deviation 0.44 |
| Let's Flex Program | Instrumental Activities of Daily Living (IADL) Test Score | T3 (56-58 weeks post baseline) | 7.71 Score on a scale | Standard Deviation 0.76 |
| Let's Flex Program | Instrumental Activities of Daily Living (IADL) Test Score | Baseline | 7.86 Score on a scale | Standard Deviation 0.66 |
| Let's Flex Program | Instrumental Activities of Daily Living (IADL) Test Score | T2 (28-30 weeks post baseline) | 7.93 Score on a scale | Standard Deviation 0.25 |
| Let's Flex Program | Instrumental Activities of Daily Living (IADL) Test Score | T1 (13-15 weeks post baseline) | 7.9 Score on a scale | Standard Deviation 0.3 |
Primary
Letter Fluency Assessed by Change in FAS Test Score
The FAS test requires stating out loud as many words that begin with the assigned letter (F, A, and S) as possible within 60-seconds. Results represent total number of words stated for F,A & S combined.
Time frame: Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)
Population: The number analyzed includes participants who were able to complete each study visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Let's Move Program | Letter Fluency Assessed by Change in FAS Test Score | Baseline | 35.91 number of correct words | Standard Deviation 10.67 |
| Let's Move Program | Letter Fluency Assessed by Change in FAS Test Score | T1 ( 13-15 weeks post baseline) | 38.51 number of correct words | Standard Deviation 11.48 |
| Let's Move Program | Letter Fluency Assessed by Change in FAS Test Score | T2 (28-30 weeks post baseline) | 37.26 number of correct words | Standard Deviation 11.18 |
| Let's Move Program | Letter Fluency Assessed by Change in FAS Test Score | T3 ( 56-58 weeks post baseline) | 38.24 number of correct words | Standard Deviation 11.93 |
| Let's Flex Program | Letter Fluency Assessed by Change in FAS Test Score | T3 ( 56-58 weeks post baseline) | 35.4 number of correct words | Standard Deviation 13.96 |
| Let's Flex Program | Letter Fluency Assessed by Change in FAS Test Score | Baseline | 31.44 number of correct words | Standard Deviation 8.64 |
| Let's Flex Program | Letter Fluency Assessed by Change in FAS Test Score | T2 (28-30 weeks post baseline) | 34.33 number of correct words | Standard Deviation 11.01 |
| Let's Flex Program | Letter Fluency Assessed by Change in FAS Test Score | T1 ( 13-15 weeks post baseline) | 31.28 number of correct words | Standard Deviation 9.1 |
Primary
NIH Toolbox
Computerized cognitive tests developed and distributed by the NIH. Tests include Pattern Comparison Processing Speed Test, Picture Vocabulary Test, Reading Recognition Test, Dimensional Change Card Sort Test, Flanker Inhibitory Control and Attention Test, Picture Sequence Memory Test, List Sorting Working Memory Test, and Oral Symbol Digit Test
Time frame: Baseline, Post Intervention (Up to 58 weeks)
Population: In order to reduce participant burden, the NIH toolbox neurocognitive tests were not administered because was redundant with the outcomes measured by the other cognitive tests.
Primary
Stroop Color and Word Test Score
The Stroop Color and Word Test is a performance-based test of executive function and inhibitory responding. The participant is presented with a page with the words red, blue, and green printed 100 times in (20 words in 5 columns). Each word is printed in a different color of ink than the target word (e.g, the word red is printed in blue ink). Participants read the color of ink in which the word is printed as quickly are possible within a time limit. The correct number within the time limit is the score. Raw scores (unadjusted for age and education) range from 0-100.
Time frame: Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)
Population: The number analyzed includes participants who were able to complete each study visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Let's Move Program | Stroop Color and Word Test Score | T2 (28-30 weeks post baseline) | 33.09 number of correct responses | Standard Deviation 8.72 |
| Let's Move Program | Stroop Color and Word Test Score | Baseline | 31.17 number of correct responses | Standard Deviation 8.13 |
| Let's Move Program | Stroop Color and Word Test Score | T3 ( 56-58 weeks post baseline) | 33.44 number of correct responses | Standard Deviation 8.74 |
| Let's Move Program | Stroop Color and Word Test Score | T1 (13-15 weeks post baseline) | 32.87 number of correct responses | Standard Deviation 8.85 |
| Let's Flex Program | Stroop Color and Word Test Score | T3 ( 56-58 weeks post baseline) | 31.77 number of correct responses | Standard Deviation 7.83 |
| Let's Flex Program | Stroop Color and Word Test Score | T2 (28-30 weeks post baseline) | 30.39 number of correct responses | Standard Deviation 9.5 |
| Let's Flex Program | Stroop Color and Word Test Score | T1 (13-15 weeks post baseline) | 30.69 number of correct responses | Standard Deviation 6.64 |
| Let's Flex Program | Stroop Color and Word Test Score | Baseline | 28.89 number of correct responses | Standard Deviation 7.59 |
Primary
Symbol Span Test Score
The subtest assesses visual working memory using novel visual stimuli. A series of abstract symbols on a page are shown briefly. Then the symbols are to be selected from an array of symbols in the same order they were presented on the previous page. This performance based test measures storage and manipulation of visual details in working memory. Score range from 0-36. Higher score correlates with better outcome.
Time frame: Baseline, 3 months, 6 months and 12 months Post Intervention
Population: The number analyzed includes participants who were able to complete each study visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Let's Move Program | Symbol Span Test Score | Baseline | 17.19 score on a scale | Standard Deviation 6.11 |
| Let's Move Program | Symbol Span Test Score | 3 months post-intervention | 19.56 score on a scale | Standard Deviation 5.76 |
| Let's Move Program | Symbol Span Test Score | 6 months post-intervention | 19.17 score on a scale | Standard Deviation 7.16 |
| Let's Move Program | Symbol Span Test Score | 12 months post-intervention | 19.56 score on a scale | Standard Deviation 5.76 |
| Let's Flex Program | Symbol Span Test Score | 12 months post-intervention | 16.78 score on a scale | Standard Deviation 5.58 |
| Let's Flex Program | Symbol Span Test Score | Baseline | 15.33 score on a scale | Standard Deviation 5.89 |
| Let's Flex Program | Symbol Span Test Score | 6 months post-intervention | 17.18 score on a scale | Standard Deviation 6.38 |
| Let's Flex Program | Symbol Span Test Score | 3 months post-intervention | 16.78 score on a scale | Standard Deviation 5.58 |
Primary
Trail Making Test Score
The Trail Making Test is a performance based test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect circles as possible while still maintaining accuracy. Trails A subtest requires the connection in sequence of 25 circles labeled by numbers. Trails B requires the connection in sequence of 25 circles labeled by alternating numbers and letters (1-A-2-B-3-C). The score on the test is the time in seconds that it takes to complete. Higher scores (i.e., time) indicate poorer performance.
Time frame: Baseline, T1 (13-15 weeks post baseline), T2 (28-30 weeks post baseline), T3 ( 56-58 weeks post baseline)
Population: The number analyzed includes participants who were able to complete each study visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Let's Move Program | Trail Making Test Score | Part A - T2 (28-30 weeks post baseline) | 34.73 seconds | Standard Deviation 17.54 |
| Let's Move Program | Trail Making Test Score | Part B - T2 (28-30 weeks post baseline) | 117.91 seconds | Standard Deviation 82.97 |
| Let's Move Program | Trail Making Test Score | Part A - Baseline | 35.84 seconds | Standard Deviation 14.11 |
| Let's Move Program | Trail Making Test Score | Part A -T1 (13-15 weeks post baseline) | 33.62 seconds | Standard Deviation 12.39 |
| Let's Move Program | Trail Making Test Score | Part A - T3 ( 56-58 weeks post baseline) | 33.29 seconds | Standard Deviation 12.49 |
| Let's Move Program | Trail Making Test Score | Part B - Baseline | 113.7 seconds | Standard Deviation 62.29 |
| Let's Move Program | Trail Making Test Score | Part B -T1 (13-15 weeks post baseline) | 109.51 seconds | Standard Deviation 58.68 |
| Let's Move Program | Trail Making Test Score | Part B - T3 ( 56-58 weeks post baseline) | 115.76 seconds | Standard Deviation 94.08 |
| Let's Flex Program | Trail Making Test Score | Part B -T1 (13-15 weeks post baseline) | 142.26 seconds | Standard Deviation 93.74 |
| Let's Flex Program | Trail Making Test Score | Part A - T2 (28-30 weeks post baseline) | 39.03 seconds | Standard Deviation 15.62 |
| Let's Flex Program | Trail Making Test Score | Part A - T3 ( 56-58 weeks post baseline) | 36.23 seconds | Standard Deviation 12.92 |
| Let's Flex Program | Trail Making Test Score | Part B - T2 (28-30 weeks post baseline) | 164.58 seconds | Standard Deviation 128.75 |
| Let's Flex Program | Trail Making Test Score | Part B - Baseline | 137.95 seconds | Standard Deviation 86.58 |
| Let's Flex Program | Trail Making Test Score | Part A - Baseline | 37.74 seconds | Standard Deviation 20.08 |
| Let's Flex Program | Trail Making Test Score | Part B - T3 ( 56-58 weeks post baseline) | 145.28 seconds | Standard Deviation 115.38 |
| Let's Flex Program | Trail Making Test Score | Part A -T1 (13-15 weeks post baseline) | 35.58 seconds | Standard Deviation 16.51 |
Secondary
Brain-derived Neurotrophic Factor (BDNF) Level
BDNF is a protein that occurs naturally in the hippocampus, cortex, and basal forebrain-areas vital to learning, memory, and higher thinking; an increase in BDNF in animal models and humans is thought to enhance neurogenesis. BDNF is reported as in picogram per milliliter (pg/mL).
Time frame: Baseline, Post Intervention (Up to 58 weeks)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Let's Move Program | Brain-derived Neurotrophic Factor (BDNF) Level | T3 (56-58 weeks) | 2347.42 pg/mL | Standard Deviation 2877.94 |
| Let's Move Program | Brain-derived Neurotrophic Factor (BDNF) Level | T2 (28-30 weeks) | 3014.45 pg/mL | Standard Deviation 3941.81 |
| Let's Move Program | Brain-derived Neurotrophic Factor (BDNF) Level | T1 (13-15 weeks) | 3142.40 pg/mL | Standard Deviation 3378.12 |
| Let's Move Program | Brain-derived Neurotrophic Factor (BDNF) Level | Baseline | 2436.95 pg/mL | Standard Deviation 2376.96 |
| Let's Flex Program | Brain-derived Neurotrophic Factor (BDNF) Level | T1 (13-15 weeks) | 2963.97 pg/mL | Standard Deviation 2678.83 |
| Let's Flex Program | Brain-derived Neurotrophic Factor (BDNF) Level | Baseline | 2910.17 pg/mL | Standard Deviation 2571.53 |
| Let's Flex Program | Brain-derived Neurotrophic Factor (BDNF) Level | T2 (28-30 weeks) | 2895.28 pg/mL | Standard Deviation 2316.84 |
| Let's Flex Program | Brain-derived Neurotrophic Factor (BDNF) Level | T3 (56-58 weeks) | 4877.86 pg/mL | Standard Deviation 7766.09 |
Secondary
Flow-Mediated Dilatation (FMD)
Flow-mediated dilatation (FMD) is a measure of endothelial function; the measure of % FMD at 60 seconds reflects arterial relaxation time after cuff deflation.
Time frame: Baseline, T2 (28-30 weeks post baseline)
Population: The number analyzed includes participants who were able to complete each study visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Let's Move Program | Flow-Mediated Dilatation (FMD) | Baseline | 4.62 percent dilation | Standard Deviation 3.2 |
| Let's Move Program | Flow-Mediated Dilatation (FMD) | T2 (28-30 weeks post baseline) | 4.31 percent dilation | Standard Deviation 2.1 |
| Let's Flex Program | Flow-Mediated Dilatation (FMD) | Baseline | 5.64 percent dilation | Standard Deviation 3.8 |
| Let's Flex Program | Flow-Mediated Dilatation (FMD) | T2 (28-30 weeks post baseline) | 5.48 percent dilation | Standard Deviation 2.6 |
Secondary
Interleukin 6 (IL-6) Level
IL-6 is a pro-inflammatory cytokine known to contribute to the pathogenesis of risk of cardiovascular disease (CVD) and cognitive impairment (CI) through inflammation and promotion of endothelial vascular dysfunction. IL-6 is measured by enzyme-linked immunosorbent assay (ELISA) and reported as in picograms per deciliter (pg/dL). Higher concentrations of IL-6 raise congenital heart defect risk.
Time frame: Baseline, T1 (13-15 Weeks), T2 (28-30 weeks), T3 (56-58 weeks)
Population: Lab assays were completed at each time-point based on the participants availability and those samples that were good for lab processing.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Let's Move Program | Interleukin 6 (IL-6) Level | Baseline | 2.5 pg/ml | Standard Deviation 3.09 |
| Let's Move Program | Interleukin 6 (IL-6) Level | T1 (13-15 wks) | 2.5 pg/ml | Standard Deviation 3.2 |
| Let's Move Program | Interleukin 6 (IL-6) Level | T2 (28-30 wks) | 2.3 pg/ml | Standard Deviation 2.06 |
| Let's Move Program | Interleukin 6 (IL-6) Level | T3 (56-58 wks) | 2.5 pg/ml | Standard Deviation 2.4 |
| Let's Flex Program | Interleukin 6 (IL-6) Level | T3 (56-58 wks) | 7.2 pg/ml | Standard Deviation 17.6 |
| Let's Flex Program | Interleukin 6 (IL-6) Level | Baseline | 5.4 pg/ml | Standard Deviation 12.5 |
| Let's Flex Program | Interleukin 6 (IL-6) Level | T2 (28-30 wks) | 4.7 pg/ml | Standard Deviation 9.9 |
| Let's Flex Program | Interleukin 6 (IL-6) Level | T1 (13-15 wks) | 5.1 pg/ml | Standard Deviation 10.9 |
Secondary
Soluble Cluster of Differentiation 14 (sCD14) Level
Soluble Cluster of Differentiation 14 (sCD14) is a marker of monocyte activation, is associated with neurocognitive impairment and HIV-associated neurocognitive disorders (HANDs) and higher mortality in persons living with HIV.
Time frame: Baseline, T1 (13-15 weeks), T2 (28-30 weeks), T3 (56 -58 weeks)
Population: Lab assays were completed at each time-point based on the participants availability and those samples that were good for lab processing.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Let's Move Program | Soluble Cluster of Differentiation 14 (sCD14) Level | Baseline | 2306.0 pg/ml | Standard Deviation 711.94 |
| Let's Move Program | Soluble Cluster of Differentiation 14 (sCD14) Level | T1 (13-15 weeks) | 2315.5 pg/ml | Standard Deviation 748.5 |
| Let's Flex Program | Soluble Cluster of Differentiation 14 (sCD14) Level | Baseline | 2373.1 pg/ml | Standard Deviation 525.3 |
| Let's Flex Program | Soluble Cluster of Differentiation 14 (sCD14) Level | T1 (13-15 weeks) | 2342.6 pg/ml | Standard Deviation 672.5 |
Secondary
Tumor Necrosis Factor Alpha (TNF-alpha) Level
TNFR1 membrane bound receptors that have been shown to bind TNF alpha. Activation of TNFR1 mediates the proinflammatory properties of TNF alpha.
Time frame: Baseline, T1 (13-15 wks), T2 (28-30 wks), T3 (56-58 wks)
Population: Lab assays were completed at each time-point based on the participants availability and those samples that were good for lab processing.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Let's Move Program | Tumor Necrosis Factor Alpha (TNF-alpha) Level | T3 (56-58 wks) | 1.6 pg/ml | Standard Deviation 0.82 |
| Let's Move Program | Tumor Necrosis Factor Alpha (TNF-alpha) Level | T1 (13-15 wks) | 1.7 pg/ml | Standard Deviation 1.08 |
| Let's Move Program | Tumor Necrosis Factor Alpha (TNF-alpha) Level | Baseline | 1.6 pg/ml | Standard Deviation 1.1 |
| Let's Move Program | Tumor Necrosis Factor Alpha (TNF-alpha) Level | T2 (28-30 wks) | 1.6 pg/ml | Standard Deviation 1.03 |
| Let's Flex Program | Tumor Necrosis Factor Alpha (TNF-alpha) Level | Baseline | 1.6 pg/ml | Standard Deviation 0.6 |
| Let's Flex Program | Tumor Necrosis Factor Alpha (TNF-alpha) Level | T3 (56-58 wks) | 1.71 pg/ml | Standard Deviation 0.8 |
| Let's Flex Program | Tumor Necrosis Factor Alpha (TNF-alpha) Level | T2 (28-30 wks) | 1.75 pg/ml | Standard Deviation 0.86 |
| Let's Flex Program | Tumor Necrosis Factor Alpha (TNF-alpha) Level | T1 (13-15 wks) | 1.71 pg/ml | Standard Deviation 0.74 |
Other Pre-specified
Beck Depression Inventory-II (BDI-II) Score
BDI-II is a 21-question multiple-choice self-report inventory, one of the most widely used instruments for measuring the severity of depression. Each answer being scored on a scale value of 0 to 3. Scores range from 0-63. Interpretation: 0 through 9 indicate no or minimal depression; scores from 10 through 18 indicate mild to moderate depression; scores from 19 through 29 indicate moderate to severe depression; and scores from 30 through 63 indicate severe depression.
Time frame: Baseline, T2 (28-30 weeks post baseline), T3 (56-58 weeks post baseline)
Population: The number analyzed includes participants who were able to complete each study visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Let's Move Program | Beck Depression Inventory-II (BDI-II) Score | Baseline | 6.95 score on a scale | Standard Deviation 5 |
| Let's Move Program | Beck Depression Inventory-II (BDI-II) Score | T2 (28-30 weeks post baseline) | 8.28 score on a scale | Standard Deviation 7 |
| Let's Move Program | Beck Depression Inventory-II (BDI-II) Score | T3 (56-58 weeks post baseline) | 7.17 score on a scale | Standard Deviation 4.45 |
| Let's Flex Program | Beck Depression Inventory-II (BDI-II) Score | Baseline | 8.64 score on a scale | Standard Deviation 6 |
| Let's Flex Program | Beck Depression Inventory-II (BDI-II) Score | T2 (28-30 weeks post baseline) | 10.79 score on a scale | Standard Deviation 4 |
| Let's Flex Program | Beck Depression Inventory-II (BDI-II) Score | T3 (56-58 weeks post baseline) | 11.13 score on a scale | Standard Deviation 4.45 |
Other Pre-specified
Exercise Regimen as Assessed by the Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire
The 41-item Community Healthy Activities Model Program for Seniors evaluates weekly duration of various types of physical activity among older adults including light, moderate and vigorous intensity levels. The activity is assessed by hours per week using 6 categories less than 1 hour to 9 or more hours. The values presented below are hours participants indicated they spent in moderate intensity activity levels at the 3 time points over the past 4 weeks. Guidelines suggest 150 minutes (2.5 hours) per week in moderate intensity physical activity, below this number is considered sedentary. We measure change from baseline in time spent in moderate intensity exercise.
Time frame: Baseline, T2 (28-30 weeks post baseline), T3 (56-58 weeks post baseline)
Population: The number analyzed includes participants who were able to complete each study visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Let's Move Program | Exercise Regimen as Assessed by the Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire | Baseline | 9.85 hours per week | Standard Deviation 10.4 |
| Let's Move Program | Exercise Regimen as Assessed by the Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire | T3 (56-58 weeks post baseline) | 9.72 hours per week | Standard Deviation 4.45 |
| Let's Move Program | Exercise Regimen as Assessed by the Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire | T2 (28-30 weeks post baseline) | 12.1 hours per week | Standard Deviation 7.56 |
| Let's Flex Program | Exercise Regimen as Assessed by the Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire | Baseline | 12.13 hours per week | Standard Deviation 10.4 |
| Let's Flex Program | Exercise Regimen as Assessed by the Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire | T3 (56-58 weeks post baseline) | 8.96 hours per week | Standard Deviation 4.45 |
| Let's Flex Program | Exercise Regimen as Assessed by the Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire | T2 (28-30 weeks post baseline) | 8.59 hours per week | Standard Deviation 7.56 |
Other Pre-specified
Pittsburgh Sleep Quality Index (PSQI) Score
The Pittsburgh Sleep Quality Index (PSQI) is a 19-item measure of the quality and patterns of sleep among adults. Scoring is based on a 0 to 3 Likert scale. The global score is 21; total possible score ranges from 0 to 21. The higher the score the worse the sleep quality.
Time frame: Baseline, T2 (28-30 weeks post baseline), T3 (56-58 weeks post baseline)
Population: The number analyzed includes participants who were able to complete each study visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Let's Move Program | Pittsburgh Sleep Quality Index (PSQI) Score | T3 (56-58 weeks post baseline) | 7.32 score on a scale | Standard Deviation 4.45 |
| Let's Move Program | Pittsburgh Sleep Quality Index (PSQI) Score | Baseline | 7.97 score on a scale | Standard Deviation 8 |
| Let's Move Program | Pittsburgh Sleep Quality Index (PSQI) Score | T2 (28-30 weeks post baseline) | 7.38 score on a scale | Standard Deviation 3.87 |
| Let's Flex Program | Pittsburgh Sleep Quality Index (PSQI) Score | T3 (56-58 weeks post baseline) | 8.55 score on a scale | Standard Deviation 4.45 |
| Let's Flex Program | Pittsburgh Sleep Quality Index (PSQI) Score | Baseline | 7.46 score on a scale | Standard Deviation 6 |
| Let's Flex Program | Pittsburgh Sleep Quality Index (PSQI) Score | T2 (28-30 weeks post baseline) | 8.13 score on a scale | Standard Deviation 3.87 |
Other Pre-specified
Six-minute Walk Test
Measure of functional capacity or submaximal exercise. Scores reflect distance walked in feet for 6 minutes duration. This is an exploratory outcome.
Time frame: Baseline, T2 (28-30 weeks post baseline), T3 (56-58 weeks post baseline)
Population: The number analyzed includes participants who were able to complete each study visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Let's Move Program | Six-minute Walk Test | Baseline | 1465.58 distance walked in feet | Standard Deviation 63.58 |
| Let's Move Program | Six-minute Walk Test | T2 (28-30 weeks post baseline) | 1469.3 distance walked in feet | Standard Deviation 261.75 |
| Let's Move Program | Six-minute Walk Test | T3 (56-58 weeks post baseline) | 1497.68 distance walked in feet | Standard Deviation 243.54 |
| Let's Flex Program | Six-minute Walk Test | Baseline | 1475.07 distance walked in feet | Standard Deviation 63.58 |
| Let's Flex Program | Six-minute Walk Test | T2 (28-30 weeks post baseline) | 1478.11 distance walked in feet | Standard Deviation 261.75 |
| Let's Flex Program | Six-minute Walk Test | T3 (56-58 weeks post baseline) | 1475.35 distance walked in feet | Standard Deviation 243.54 |
Other Pre-specified
V02 Max Rate
V02 max is the maximum rate of oxygen consumption as measured during incremental exercise using the Balke treadmill test. This is an exploratory outcome.
Time frame: Baseline
Population: Number analyzed includes participants that completed the baseline visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Let's Move Program | V02 Max Rate | 20.48 mL/kg/min | Standard Deviation 19.5 |
| Let's Flex Program | V02 Max Rate | 20.67 mL/kg/min | Standard Deviation 20.3 |