Cognitive Ability General, Difficulty Walking, Mobility Limitation, Motor Activity
Conditions
Brief summary
The investigators propose to conduct a single-blind randomized clinical trial to test the efficacy of a computerized cognitive remediation intervention program on improving locomotion in sedentary seniors, a group at an especially high risk for disability. The hypothesis is that executive functions will respond to the cognitive remediation program and in turn enhance locomotion.
Detailed description
Emerging evidence indicates that Executive Functions play an important role in maintaining locomotion in aging and preventing mobility disabilities. However, use of cognitive training programs to improve executive functions as a strategy to increase mobility has not been explored. Exciting results from the preliminary study support the efficacy and feasibility of the cognitive remediation approach to improve locomotion in older adults. The premise of this clinical trial is that disability among seniors is a potentially preventable chronic condition rather than an irreversible consequence of aging and disease. The investigators proposed novel approach to locomotion has the potential to shift treatment paradigms in the field of disability by introducing cognitive approaches to mobility that can be applied to prevention and rehabilitation in diverse settings. Through this 'proof of concept' secondary prevention trial the investigators will fill an important gap in knowledge for practicing evidence-based medicine and developing effective interventions for a major health outcome affecting a substantial proportion of the U.S. aging population.
Interventions
OTHERCognitive Remediation
This computerized program has successfully been used by seniors in different settings. It trains a number of cognitive processes including attention and Executive Function.The Cognitive Remediation (CREM) training is constructed based on the program's built in baseline cognitive evaluation.
OTHERActive Control
Computer, multimedia and group based health education programs.
Sponsors
National Institute on Aging (NIA)
Albert Einstein College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Adults aged 70 and older, residing in the community. 2. Plan to be in area for next year. 3. Able to speak English at a level sufficient to undergo our cognitive assessment battery. 4. Ambulatory. Subjects are classified as 'non-ambulatory' if they are unable to leave the confines of their home and attend a clinic visit. 5. Gait velocity ≤1 m/s. 6. Short Physical Performance Battery score ≤9.
Exclusion criteria
1. Presence of dementia identified by any one of the following: Telephone based Memory Impairment Screen score (T-MIS) of \<5, Alzheimer's Disease 8 (AD8) ≥ 2. Or dementia diagnosed by baseline cognitive assessment. 2. Serious chronic or acute illness such as cancer (late stage, metastatic, or on active treatment), chronic pulmonary disease on ventilator or continuous oxygen therapy or active liver disease. 3. Mobility limitations solely due to musculoskeletal limitation or pain (e.g., severe osteoarthritis) that prevent subjects from completing mobility tests. Presence of arthritis will not be used to exclude subjects if they can complete the mobility tasks. 4. Any medical condition or chronic medication use (e.g., neuroleptics) that will compromise safety or affect cognitive functioning or terminal illness with life expectancy less than 12 months. 5. Presence of progressive, degenerative neurologic disease (e.g., Parkinson's disease or ALS). 6. Hospitalized in the past 6 months for severe illness or surgery that specifically affects mobility (e.g. hip or knee replacement) and that prevent subjects from completing mobility tests or plans for surgery affecting mobility in the next 6 months. 7. Severe auditory or visual loss. 8. Active psychoses or psychiatric symptoms (such as agitation) noted during the clinic visit that will prevent completion of study protocols. 9. Living in nursing home. 10. Participation in other intervention trial or observational studies. -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Walking Speed During Single and Dual-task Conditions. | Baseline and 2 months | Between group difference in change per arm of gait speed (centimeters/second) measured during normal pace walking and walking while talking conditions using an instrumented walkway (GAITRite® electronic walkway system). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Variability in Gait Domains | Baseline and 2 Months | Between group difference in change per arm in gait domains (summary measures reported as standard deviation units) derived from factor analysis of quantitative gait variables collected on an instrumented walkway during normal walking and walking while talking. Based on previous findings of gait patterns, pace, rhythm and variation factors are defined (using z-scores based on mean and standard deviation at baseline). Higher values are indicative of better performance for pace and rhythm factors and indicative of worse performance for variation factors. |
| Digit Symbol Substitution Test. | Baseline and 2 Months | Between group difference in change per arm on the Digit Symbol Substitution Test (a subtest of the Wechsler Adult Intelligence Scale - Revised), a measure of attention, transcription and speed of processing. Scoring is based on the total number of correct responses generated during a 90-sec time interval. Scores range from 0-133 with higher scores indicating better performance. |
| Trail Making Test Form A. | Baseline and 2 Months | Between group difference in change per arm on Trail Making Test form A, a timed measure of attention. Scoring is based on the time required to complete the task and on accuracy. Scores range from 0-300 seconds with longer time indicating worse performance. Scores were log transformed prior to analysis. |
| Trail Making Test Form B. | Baseline and 2 Months | Between group difference in change per arm on Trail Making Test form B, a timed measure of attention, set shifting and processing speed. Scoring is based on the time required to complete the task and on accuracy. Scores range from 0-300 seconds with longer time indicating worse performance. Scores were log transformed prior to analysis. |
| Controlled Oral Word Association Test. | Baseline and 2 Months | Between group difference in change per arm on the Controlled Oral Word Association Test, a verbal fluency test that measures word generation performance under specified timed phonemic and semantic conditions. Performance measured by the total number of correct words as well as the number of errors. Scores range from 25-41 seconds with higher scores indicating better performance. |
| Repeatable Battery for the Assessment of Neuropsychological Status. | Baseline and 2 Months | Between group difference in change on the Repeatable Battery for the Assessment of Neuropsychological Status, a relatively brief battery that assesses overall level of cognitive function This battery consists of 10 neurocognitive tests measuring memory (immediate and delayed), attention, language, visuospatial abilities and executive functions. Performance is converted to standardized scores derived from a normative sample. |
| Neuroplasticity. | Baseline and 2 Months | Changes in prefrontal activation measure using functional near infra-red spectroscopy. |
| Durability | Baseline and 6 months | Between group difference in change per arm in gait speed during normal pace and walking while talking conditions measured at six months. |
| Stair Climbing Time. | Baseline and 2 Months | Between group difference in change per arm in mobility and balance assessed during stair climbing, which provides a valid assessment tool for predicting disability. Scores are measured as time in seconds to climb 3 stairs with longer time indicating worse performance. Scores were log transformed prior to analysis. |
| Disability Scale. | Baseline and 2 Months | Between group difference in change per arm in mobility assessed by activities of daily living tasks on the Activities of Daily Living-Prevention Instrument. Scores range from 0-45 and higher scores indicate poorer function. |
| Change in Short Physical Performance Battery (SPPB). | Baseline and 2 months | Between group difference in change per arm in mobility measured using the SPPB. The SPPB is comprised of balance, chair rise, and gait speed tests. A score is assigned in each of these three areas (0-4), and summed to obtain an overall summary score (0-12, higher better). |
| Stride Length. | Baseline and 2 months | Between group difference in change per arm in stride length (cm) collected during normal walking and walking while talking conditions on an instrumented walkway. |
| Gait Variability. | Baseline and 2 months | Between group difference in change per arm in gait stride length variability, measured in standard deviation units, collected during normal walking and walking while talking on an instrumented walkway. Gait variability is defined as differences in length from one stride to the next. |
| Number of Participants With Substantial Gait Speed Change. | Baseline and 2 Months | Substantial gait speed improvement is defined as change of ≥1 standard deviation units from baseline performance in gait speed measured during normal walking and walking while talking conditions. |
| Flanker Task. | Baseline and 2 Months | Between group difference in change per arm on the Flanker task, a measure of speed of processing, attention and inhibitory control. Scoring is based on reaction time in milliseconds (ms) and calculated as the difference in reaction time that it takes a person, on average, to respond to an incongruent minus congruent stimulus. Lower values reflect better outcome. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Falls Efficacy Scale. | Baseline and 2 months | Between group difference in change per arm in self-efficacy scores (range 0-100). Higher scores indicate less confidence. |
| 12-Item Short Form Health Survey (SF-12). | Baseline and 2 months | Between group difference in change per arm in perceptions of health and quality of life in domains that include social, physical, emotional and mental functions. The SF-12 has 12 items; two component scores capturing perceptions of mental and physical function can be derived. The Physical Component Summary (PCS-12) and Mental Component Summary (MCS-12) scores are calculated using 12 questions with a range of 0-100 (zero indicating the poorest level of health measured and 100 indicating the highest). |
| Falls. | Baseline and 12 Months | Presence and number of falls over 12 months from baseline. |
| Number of Participants With Progression in Cognitive Impairment From Normal Cognitive Function at Baseline to Mild Cognitive Impairment (MCI) | Baseline and 2 Months | Progression in cognitive impairment from normal cognitive function at baseline to MCI. |
| Number of Participants With Progression in Cognitive Impairment From Normal Cognitive Function at Baseline to Dementia | Baseline and 2 Months | Progression in cognitive impairment from baseline normal cognitive function to dementia. |
| Number of Participants With Progression in Cognitive Impairment From Normal Cognitive Function at Baseline to Motoric Cognitive Risk Syndrome (MCR) | Baseline and 2 Months | Progression in cognitive impairment from baseline normal cognitive function to MCR. |
| Number of Participants With Progression in Cognitive Impairment From Normal Cognitive Function at Baseline to Cognitively Impaired | Baseline and 2 Months | Progression in cognitive impairment from baseline normal cognitive function to cognitive impairment defined as presence of incident MCI, dementia, or MCR. |
| Rosenberg Self-Esteem Scale. | Baseline and 2 months | Between group difference in change per arm in self-esteem assessed using a ten-item Likert-type scale (higher scores are better). |
| The Geriatric Depression Scale (GDS). | Baseline and 2 months | Between group difference in change per arm in depressive symptoms assessed using the 30 item GDS, scores range from 0 (not depressed) to 30 (depressed). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cognitive Remediation An individualized computerized cognitive remediation program.
Cognitive Remediation: This computerized program has successfully been used by seniors in different settings. It trains a number of cognitive processes including attention and Executive Function.The Cognitive Remediation (CREM) training is constructed based on the program's built in baseline cognitive evaluation. | 186 |
| Active Control Individualized computer based exposure and interactive health education classes.
Active Control: Computer, multimedia and group based health education programs. | 186 |
| Total | 372 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 12 Months | Death | 0 | 2 |
| 12 Months | Lost to Follow-up | 31 | 32 |
| 6 Month | Death | 2 | 0 |
| 6 Month | Lost to Follow-up | 43 | 40 |
| 9 Weeks | Adverse Event | 5 | 5 |
| 9 Weeks | Study suspended due to COVID-19 pandemic | 11 | 11 |
| 9 Weeks | Withdrawal by Subject | 18 | 8 |
Baseline characteristics
| Characteristic | Cognitive Remediation | Active Control | Total |
|---|---|---|---|
| Age, Continuous | 76.94 years STANDARD_DEVIATION 5.66 | 77.18 years STANDARD_DEVIATION 5.61 | 77.03 years STANDARD_DEVIATION 5.61 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 28 Participants | 34 Participants | 62 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 151 Participants | 142 Participants | 293 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 7 Participants | 10 Participants | 17 Participants |
| Gait Speed, cm/s | 75.82 centimeters per second STANDARD_DEVIATION 17.73 | 75.92 centimeters per second STANDARD_DEVIATION 16.81 | 75.87 centimeters per second STANDARD_DEVIATION 17.25 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 5 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 93 Participants | 90 Participants | 183 Participants |
| Race (NIH/OMB) More than one race | 28 Participants | 34 Participants | 62 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 10 Participants | 17 Participants |
| Race (NIH/OMB) White | 57 Participants | 47 Participants | 104 Participants |
| Region of Enrollment United States | 186 participants | 186 participants | 372 participants |
| Sex: Female, Male Female | 135 Participants | 136 Participants | 271 Participants |
| Sex: Female, Male Male | 51 Participants | 50 Participants | 101 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 192 | 2 / 191 |
| other Total, other adverse events | 49 / 192 | 34 / 191 |
| serious Total, serious adverse events | 5 / 192 | 1 / 191 |
Outcome results
Primary
Change in Walking Speed During Single and Dual-task Conditions.
Between group difference in change per arm of gait speed (centimeters/second) measured during normal pace walking and walking while talking conditions using an instrumented walkway (GAITRite® electronic walkway system).
Time frame: Baseline and 2 months
Population: Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 in Experimental; n=5 in Active Comparator).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Remediation | Change in Walking Speed During Single and Dual-task Conditions. | Walking while talking | 6.02 centimeters per second | Standard Error 1.16 |
| Cognitive Remediation | Change in Walking Speed During Single and Dual-task Conditions. | Normal pace walking | 1.73 centimeters per second | Standard Error 0.94 |
| Active Control | Change in Walking Speed During Single and Dual-task Conditions. | Normal pace walking | 2.76 centimeters per second | Standard Error 0.91 |
| Active Control | Change in Walking Speed During Single and Dual-task Conditions. | Walking while talking | 5.43 centimeters per second | Standard Error 1.13 |
Comparison: Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (Mild Cognitive Impairment (MCI) or cognitively normal) were used to compare changes in speed during normal pace walking pre and post intervention.95% CI: [-3.6, 1.54]
Comparison: Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in speed during walking while talking pre and post intervention.95% CI: [-2.59, 3.76]
Secondary
Change in Short Physical Performance Battery (SPPB).
Between group difference in change per arm in mobility measured using the SPPB. The SPPB is comprised of balance, chair rise, and gait speed tests. A score is assigned in each of these three areas (0-4), and summed to obtain an overall summary score (0-12, higher better).
Time frame: Baseline and 2 months
Population: Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 in Experimental; n=5 in Active Comparator)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Remediation | Change in Short Physical Performance Battery (SPPB). | 0.70 score on a scale | Standard Error 0.13 |
| Active Control | Change in Short Physical Performance Battery (SPPB). | 0.85 score on a scale | Standard Error 0.12 |
Comparison: Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in SPPB scores pre and post intervention.95% CI: [-0.49, 0.2]
Secondary
Controlled Oral Word Association Test.
Between group difference in change per arm on the Controlled Oral Word Association Test, a verbal fluency test that measures word generation performance under specified timed phonemic and semantic conditions. Performance measured by the total number of correct words as well as the number of errors. Scores range from 25-41 seconds with higher scores indicating better performance.
Time frame: Baseline and 2 Months
Population: Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 Experimental; n=5 Active Comparator).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Remediation | Controlled Oral Word Association Test. | 1.20 score on a scale | Standard Error 0.56 |
| Active Control | Controlled Oral Word Association Test. | 0.53 score on a scale | Standard Error 0.54 |
Comparison: Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes performance on the Controlled Oral Word Association Test pre and post intervention.95% CI: [-0.86, 2.2]
Secondary
Digit Symbol Substitution Test.
Between group difference in change per arm on the Digit Symbol Substitution Test (a subtest of the Wechsler Adult Intelligence Scale - Revised), a measure of attention, transcription and speed of processing. Scoring is based on the total number of correct responses generated during a 90-sec time interval. Scores range from 0-133 with higher scores indicating better performance.
Time frame: Baseline and 2 Months
Population: Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 Experimental; n=5 Active Comparator).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Remediation | Digit Symbol Substitution Test. | 2.22 score on a scale | Standard Error 0.48 |
| Active Control | Digit Symbol Substitution Test. | 1.21 score on a scale | Standard Error 0.46 |
Comparison: Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes on the Digit Symbol Substitution Test pre and post intervention.95% CI: [-0.3, 2.31]
Secondary
Disability Scale.
Between group difference in change per arm in mobility assessed by activities of daily living tasks on the Activities of Daily Living-Prevention Instrument. Scores range from 0-45 and higher scores indicate poorer function.
Time frame: Baseline and 2 Months
Population: Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 Experimental; n=5 Active Comparator).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Remediation | Disability Scale. | -0.18 score on a scale | Standard Error 0.21 |
| Active Control | Disability Scale. | -0.21 score on a scale | Standard Error 0.24 |
Comparison: Unadjusted linear mixed effects model was used to compare changes in activities of daily living pre and post intervention.
Secondary
Durability
Between group difference in change per arm in gait speed during normal pace and walking while talking conditions measured at six months.
Time frame: Baseline and 6 months
Population: Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 Experimental; n=5 Active Comparator).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Remediation | Durability | Normal Walking Gait Speed | -0.47 centimeters per second | Standard Error 1.03 |
| Cognitive Remediation | Durability | Walking While Talking Gait Speed | 3.16 centimeters per second | Standard Error 1.3 |
| Active Control | Durability | Normal Walking Gait Speed | -1.60 centimeters per second | Standard Error 0.97 |
| Active Control | Durability | Walking While Talking Gait Speed | 1.77 centimeters per second | Standard Error 1.23 |
Comparison: Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in gait speed during normal walking pre and 6 months post intervention.95% CI: [-1.65, 3.91]
Comparison: Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in gait speed during walking while talking pre and 6 months post intervention.95% CI: [-2.12, 4.91]
Secondary
Flanker Task.
Between group difference in change per arm on the Flanker task, a measure of speed of processing, attention and inhibitory control. Scoring is based on reaction time in milliseconds (ms) and calculated as the difference in reaction time that it takes a person, on average, to respond to an incongruent minus congruent stimulus. Lower values reflect better outcome.
Time frame: Baseline and 2 Months
Population: Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 Experimental; n=5 Active Comparator) and 86 participants (n=43 Experimental; n=43 Active Comparator) with performance inaccuracy \>75%.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Remediation | Flanker Task. | -9.05 milliseconds | Standard Error 9.48 |
| Active Control | Flanker Task. | -1.54 milliseconds | Standard Error 10.55 |
Comparison: Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in Flanker performance (milliseconds) pre and post intervention.95% CI: [-35.45, 20.41]
Secondary
Gait Variability.
Between group difference in change per arm in gait stride length variability, measured in standard deviation units, collected during normal walking and walking while talking on an instrumented walkway. Gait variability is defined as differences in length from one stride to the next.
Time frame: Baseline and 2 months
Population: Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 Experimental; n=5 Active Comparator).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Remediation | Gait Variability. | Normal walking gait variability | -0.37 standard deviation | Standard Error 0.25 |
| Cognitive Remediation | Gait Variability. | Walking while talking gait variability | -0.52 standard deviation | Standard Error 0.26 |
| Active Control | Gait Variability. | Normal walking gait variability | -0.13 standard deviation | Standard Error 0.24 |
| Active Control | Gait Variability. | Walking while talking gait variability | -0.08 standard deviation | Standard Error 0.26 |
Comparison: Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in stride length variability during normal walking pre and post intervention.95% CI: [-0.91, 0.43]
Comparison: Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in stride length variability during walking while talking pre and post intervention.95% CI: [-1.16, 0.27]
Secondary
Neuroplasticity.
Changes in prefrontal activation measure using functional near infra-red spectroscopy.
Time frame: Baseline and 2 Months
Population: No outcome measure data was collected for this outcome.
Secondary
Number of Participants With Substantial Gait Speed Change.
Substantial gait speed improvement is defined as change of ≥1 standard deviation units from baseline performance in gait speed measured during normal walking and walking while talking conditions.
Time frame: Baseline and 2 Months
Population: Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 Experimental; n=5 Active Comparator) and participants who did not complete the 2 month follow-up assessment (n=34 Experimental; n=24 Active Comparator).
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Cognitive Remediation | Number of Participants With Substantial Gait Speed Change. | Substantial normal walking speed improvement | Improved walking speed ≥1 standard deviation units from baseline | 10 Participants |
| Cognitive Remediation | Number of Participants With Substantial Gait Speed Change. | Substantial normal walking speed improvement | Did not improve walking speed ≥1 standard deviation units from baseline | 142 Participants |
| Cognitive Remediation | Number of Participants With Substantial Gait Speed Change. | Substantial walking while talking speed improvement | Improved walking speed ≥1 standard deviation units from baseline | 23 Participants |
| Cognitive Remediation | Number of Participants With Substantial Gait Speed Change. | Substantial walking while talking speed improvement | Did not improve walking speed ≥1 standard deviation units from baseline | 129 Participants |
| Active Control | Number of Participants With Substantial Gait Speed Change. | Substantial walking while talking speed improvement | Did not improve walking speed ≥1 standard deviation units from baseline | 137 Participants |
| Active Control | Number of Participants With Substantial Gait Speed Change. | Substantial normal walking speed improvement | Improved walking speed ≥1 standard deviation units from baseline | 11 Participants |
| Active Control | Number of Participants With Substantial Gait Speed Change. | Substantial walking while talking speed improvement | Improved walking speed ≥1 standard deviation units from baseline | 25 Participants |
| Active Control | Number of Participants With Substantial Gait Speed Change. | Substantial normal walking speed improvement | Did not improve walking speed ≥1 standard deviation units from baseline | 151 Participants |
Comparison: Logistic model for treatment effect on substantial improvement in normal velocity adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal).95% CI: [0.369, 2.319]
Comparison: Logistic model for treatment effect on substantial improvement in walking while talking velocity adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal).95% CI: [0.516, 1.789]
Secondary
Repeatable Battery for the Assessment of Neuropsychological Status.
Between group difference in change on the Repeatable Battery for the Assessment of Neuropsychological Status, a relatively brief battery that assesses overall level of cognitive function This battery consists of 10 neurocognitive tests measuring memory (immediate and delayed), attention, language, visuospatial abilities and executive functions. Performance is converted to standardized scores derived from a normative sample.
Time frame: Baseline and 2 Months
Population: No outcome measure data was collected for this outcome.
Secondary
Stair Climbing Time.
Between group difference in change per arm in mobility and balance assessed during stair climbing, which provides a valid assessment tool for predicting disability. Scores are measured as time in seconds to climb 3 stairs with longer time indicating worse performance. Scores were log transformed prior to analysis.
Time frame: Baseline and 2 Months
Population: Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 Experimental; n=5 Active Comparator).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Remediation | Stair Climbing Time. | -0.02 log (seconds) | Standard Error 0.03 |
| Active Control | Stair Climbing Time. | 0.01 log (seconds) | Standard Error 0.02 |
Comparison: Unadjusted linear mixed effects model was used to compare changes in stair climbing time pre and post intervention.
Secondary
Stride Length.
Between group difference in change per arm in stride length (cm) collected during normal walking and walking while talking conditions on an instrumented walkway.
Time frame: Baseline and 2 months
Population: Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 Experimental; n=5 Active Comparator).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Remediation | Stride Length. | Walking while talking stride length | 3.09 centimeters | Standard Error 1.08 |
| Cognitive Remediation | Stride Length. | Normal walking stride length | 0.13 centimeters | Standard Error 0.81 |
| Active Control | Stride Length. | Walking while talking stride length | 2.26 centimeters | Standard Error 1.05 |
| Active Control | Stride Length. | Normal walking stride length | 2.08 centimeters | Standard Error 0.66 |
Comparison: Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in stride length during walking while talking pre and post intervention.95% CI: [-2.13, 3.79]
Comparison: Unadjusted linear mixed effects models were used to compare changes in stride length during normal walking pre and post intervention.
Secondary
Trail Making Test Form A.
Between group difference in change per arm on Trail Making Test form A, a timed measure of attention. Scoring is based on the time required to complete the task and on accuracy. Scores range from 0-300 seconds with longer time indicating worse performance. Scores were log transformed prior to analysis.
Time frame: Baseline and 2 Months
Population: Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 Experimental; n=5 Active Comparator).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Remediation | Trail Making Test Form A. | -0.06 log (scores on a scale) | Standard Error 0.02 |
| Active Control | Trail Making Test Form A. | -0.07 log (scores on a scale) | Standard Error 0.02 |
Comparison: Unadjusted linear mixed effects model was used to compare performance on Trail Making Test form A pre and post intervention.
Secondary
Trail Making Test Form B.
Between group difference in change per arm on Trail Making Test form B, a timed measure of attention, set shifting and processing speed. Scoring is based on the time required to complete the task and on accuracy. Scores range from 0-300 seconds with longer time indicating worse performance. Scores were log transformed prior to analysis.
Time frame: Baseline and 2 Months
Population: Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 Experimental; n=5 Active Comparator).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Remediation | Trail Making Test Form B. | -0.10 log (scores on a scale) | Standard Error 0.024 |
| Active Control | Trail Making Test Form B. | -0.10 log (scores on a scale) | Standard Error 0.02 |
Comparison: Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in performance on Trail Making Test form B pre and post intervention.95% CI: [-0.07, 0.06]
Secondary
Variability in Gait Domains
Between group difference in change per arm in gait domains (summary measures reported as standard deviation units) derived from factor analysis of quantitative gait variables collected on an instrumented walkway during normal walking and walking while talking. Based on previous findings of gait patterns, pace, rhythm and variation factors are defined (using z-scores based on mean and standard deviation at baseline). Higher values are indicative of better performance for pace and rhythm factors and indicative of worse performance for variation factors.
Time frame: Baseline and 2 Months
Population: Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 Experimental; n=5 Active Comparator).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Remediation | Variability in Gait Domains | Normal walking pace | 0.21 standard deviation | Standard Error 0.14 |
| Cognitive Remediation | Variability in Gait Domains | Normal walking rhythm | 0.36 standard deviation | Standard Error 0.12 |
| Cognitive Remediation | Variability in Gait Domains | Normal walking variation | 0.07 standard deviation | Standard Error 0.16 |
| Cognitive Remediation | Variability in Gait Domains | Walking while talking pace | 0.75 standard deviation | Standard Error 0.15 |
| Cognitive Remediation | Variability in Gait Domains | Walking while talking rhythm | 0.72 standard deviation | Standard Error 0.15 |
| Cognitive Remediation | Variability in Gait Domains | Walking while talking variation | -0.24 standard deviation | Standard Error 0.11 |
| Active Control | Variability in Gait Domains | Walking while talking rhythm | 0.74 standard deviation | Standard Error 0.19 |
| Active Control | Variability in Gait Domains | Normal walking pace | 0.37 standard deviation | Standard Error 0.11 |
| Active Control | Variability in Gait Domains | Walking while talking pace | 0.60 standard deviation | Standard Error 0.15 |
| Active Control | Variability in Gait Domains | Normal walking rhythm | 0.25 standard deviation | Standard Error 0.1 |
| Active Control | Variability in Gait Domains | Walking while talking variation | -0.22 standard deviation | Standard Error 0.15 |
| Active Control | Variability in Gait Domains | Normal walking variation | -0.15 standard deviation | Standard Error 0.13 |
Comparison: Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in the pace domain during normal pace walking pre and post intervention.95% CI: [-0.51, 0.19]
Comparison: Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in the rhythm domain during normal pace walking pre and post intervention.95% CI: [-0.2, 0.41]
Comparison: Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in the variation domain during normal pace walking pre and post intervention.95% CI: [-0.53, 0.32]
Comparison: Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in the pace domain during walking while talking pre and post intervention.95% CI: [-0.27, 0.56]
Comparison: Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in the rhythm domain during walking while talking pre and post intervention.95% CI: [-0.48, 0.45]
Comparison: Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in the variation domain during walking while talking pre and post intervention.95% CI: [-0.4, 0.35]
Other Pre-specified
12-Item Short Form Health Survey (SF-12).
Between group difference in change per arm in perceptions of health and quality of life in domains that include social, physical, emotional and mental functions. The SF-12 has 12 items; two component scores capturing perceptions of mental and physical function can be derived. The Physical Component Summary (PCS-12) and Mental Component Summary (MCS-12) scores are calculated using 12 questions with a range of 0-100 (zero indicating the poorest level of health measured and 100 indicating the highest).
Time frame: Baseline and 2 months
Population: Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 Experimental; n=5 Active Comparator).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cognitive Remediation | 12-Item Short Form Health Survey (SF-12). | Physical Component Summary | 0.31 score on a scale | Standard Error 0.45 |
| Cognitive Remediation | 12-Item Short Form Health Survey (SF-12). | Mental Component Summary | -0.76 score on a scale | Standard Error 0.5 |
| Active Control | 12-Item Short Form Health Survey (SF-12). | Physical Component Summary | 0.52 score on a scale | Standard Error 0.45 |
| Active Control | 12-Item Short Form Health Survey (SF-12). | Mental Component Summary | -1.17 score on a scale | Standard Error 0.53 |
Comparison: Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in the physical health score of the SF-12 pre and post intervention.95% CI: [-1.46, 1.04]
Comparison: Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in the mental health score of the SF-12 pre and post intervention.95% CI: [-1.04, 1.85]
Other Pre-specified
Falls.
Presence and number of falls over 12 months from baseline.
Time frame: Baseline and 12 Months
Other Pre-specified
Falls Efficacy Scale.
Between group difference in change per arm in self-efficacy scores (range 0-100). Higher scores indicate less confidence.
Time frame: Baseline and 2 months
Population: Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 Experimental; n=5 Active Comparator).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Remediation | Falls Efficacy Scale. | 0.79 score on a scale | Standard Error 0.69 |
| Active Control | Falls Efficacy Scale. | 0.40 score on a scale | Standard Error 0.58 |
Comparison: Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in reported fear of falling measured on the Falls Efficacy Scale pre and post intervention.95% CI: [-1.38, 2.16]
Other Pre-specified
Number of Participants With Progression in Cognitive Impairment From Normal Cognitive Function at Baseline to Cognitively Impaired
Progression in cognitive impairment from baseline normal cognitive function to cognitive impairment defined as presence of incident MCI, dementia, or MCR.
Time frame: Baseline and 2 Months
Other Pre-specified
Number of Participants With Progression in Cognitive Impairment From Normal Cognitive Function at Baseline to Dementia
Progression in cognitive impairment from baseline normal cognitive function to dementia.
Time frame: Baseline and 2 Months
Other Pre-specified
Number of Participants With Progression in Cognitive Impairment From Normal Cognitive Function at Baseline to Mild Cognitive Impairment (MCI)
Progression in cognitive impairment from normal cognitive function at baseline to MCI.
Time frame: Baseline and 2 Months
Other Pre-specified
Number of Participants With Progression in Cognitive Impairment From Normal Cognitive Function at Baseline to Motoric Cognitive Risk Syndrome (MCR)
Progression in cognitive impairment from baseline normal cognitive function to MCR.
Time frame: Baseline and 2 Months
Other Pre-specified
Rosenberg Self-Esteem Scale.
Between group difference in change per arm in self-esteem assessed using a ten-item Likert-type scale (higher scores are better).
Time frame: Baseline and 2 months
Population: Only baseline data was collected on this outcome measure, therefore no data was analyzed.
Other Pre-specified
The Geriatric Depression Scale (GDS).
Between group difference in change per arm in depressive symptoms assessed using the 30 item GDS, scores range from 0 (not depressed) to 30 (depressed).
Time frame: Baseline and 2 months
Population: Includes all participants who were randomized. Excludes participants diagnosed with dementia post-hoc (n=6 Experimental; n=5 Active Comparator).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Remediation | The Geriatric Depression Scale (GDS). | 0.41 score on a scale | Standard Error 0.26 |
| Active Control | The Geriatric Depression Scale (GDS). | 0.15 score on a scale | Standard Error 0.21 |
Comparison: Linear mixed effects model adjusted for age, sex, education (school years), comorbidities score (0-10), pain, Duke score (cardiac fitness), and cognitive status (MCI or cognitively normal) were used to compare changes in depressive symptoms measured using the GDS pre and post intervention.95% CI: [-0.4, 0.93]