Trial Outcomes & Findings for Lifestyle Physical Activity and Cognitive Training Interventions (NCT NCT04556305)
NCT ID: NCT04556305
Last Updated: 2025-12-03
Results Overview
The East Boston Memory Test is a performance-based neurocognitive test. Participants are read a brief story with 12 key elements. The participants are asked to recall elements immediately and again after three-minute delay. Each score (immediate and delayed recall) has a scale of 0-12, with a higher score indicating better cognitive performance. The total score is an average of the two subscores for immediate and delayed recall. The total score has a scale of 0-12, with a higher score indicating better cognitive performance.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
253 participants
Primary outcome timeframe
Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline
Results posted on
2025-12-03
Participant Flow
Participants were recruited from two cardiology clinics (one at an academic medical center and one at a nearby community hospital affiliated with the academic medical center) in an urban Midwest area. The study was conducted from 2020 to 2024 in Chicago, Illinois, with enrollment from October 2020 to May 2022 (planned target enrollment achieved), and a final follow-up January 2024.
A total of 24 cohorts (12 cohorts per each of the two clinic sites) of 10-11 participants each were recruited sequentially prior to baseline assessment. Cluster randomization was used to assign cohorts to cells due to the Move intervention being group-based. Following randomization, the intervention condition was revealed and started at the intervention orientation.
Participant milestones
| Measure |
Mind - BrainHQ Cognitive Training Intervention
The Mind intervention uses the evidence-based BrainHQ computerized cognitive training program. BrainHQ focuses on improving memory, attention, sensory function, and working memory, and has demonstrated efficacy in improving memory among healthy older adults and adults with heart failure. BrainHQ is tailored to the individual, and program difficulty automatically progresses based on performance. Training occurs during three 30-minute sessions per week, for a total of 36 hours. Participants will complete the BrainHQ program on an iPad tablet, which will be provided to them.
Mind: See arm description.
|
Move - Lifestyle Physical Activity Intervention
The Move intervention is a 24-week evidence-based program based on social cognitive theory. It was originally developed for midlife women and successfully maintained increased physical activity. It has since been tailored for older women with CVD to prevent or delay cognitive decline, and includes: (1) education on the importance of lifestyle physical activity for brain health, (2) increasing lifestyle physical activity while considering CVD, and (3) including a goal for increasing Fitbit "active" minutes (≥ 3 METs or moderate-intensity physical activity) to ensure participants are obtaining the beneficial aerobic fitness effects during periods of lifestyle physical activity. Core elements include a personal lifestyle physical activity goal and five group meetings.
Move: See arm description.
|
MindMoves - Cognitive Training and Lifestyle Physical Activity
Participants who are assigned to this condition will complete both the Move lifestyle physical activity program and the Mind BrainHQ cognitive training intervention simultaneously for 24 weeks (see Move and Mind descriptions). Participants will receive both a Fitbit and iPad tablet to complete the combined MindMoves intervention.
Mind: See arm description.
Move: See arm description.
|
Usual Care
Participants in the usual care group do not receive any Mind- or Move-related intervention, and will receive their usual care from their cardiology provider.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
64
|
61
|
64
|
64
|
|
Overall Study
COMPLETED
|
54
|
57
|
54
|
55
|
|
Overall Study
NOT COMPLETED
|
10
|
4
|
10
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lifestyle Physical Activity and Cognitive Training Interventions
Baseline characteristics by cohort
| Measure |
Mind - BrainHQ Cognitive Training Intervention
n=64 Participants
The Mind intervention uses the evidence-based BrainHQ computerized cognitive training program. BrainHQ focuses on improving memory, attention, sensory function, and working memory, and has demonstrated efficacy in improving memory among healthy older adults and adults with heart failure. BrainHQ is tailored to the individual, and program difficulty automatically progresses based on performance. Training occurs during three 30-minute sessions per week, for a total of 36 hours. Participants will complete the BrainHQ program on an iPad tablet, which will be provided to them.
Mind: See arm description.
|
Move - Lifestyle Physical Activity Intervention
n=61 Participants
The Move intervention is a 24-week evidence-based program based on social cognitive theory. It was originally developed for midlife women and successfully maintained increased physical activity. It has since been tailored for older women with CVD to prevent or delay cognitive decline, and includes: (1) education on the importance of lifestyle physical activity for brain health, (2) increasing lifestyle physical activity while considering CVD, and (3) including a goal for increasing Fitbit "active" minutes (≥ 3 METs or moderate-intensity physical activity) to ensure participants are obtaining the beneficial aerobic fitness effects during periods of lifestyle physical activity. Core elements include a personal lifestyle physical activity goal and five group meetings.
Move: See arm description.
|
MindMoves - Cognitive Training and Lifestyle Physical Activity
n=64 Participants
Participants who are assigned to this condition will complete both the Move lifestyle physical activity program and the Mind BrainHQ cognitive training intervention simultaneously for 24 weeks (see Move and Mind descriptions). Participants will receive both a Fitbit and iPad tablet to complete the combined MindMoves intervention.
Mind: See arm description.
Move: See arm description.
|
Usual Care
n=64 Participants
Participants in the usual care group do not receive any Mind- or Move-related intervention, and will receive their usual care from their cardiology provider.
|
Total
n=253 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
74.3 years
STANDARD_DEVIATION 6.5 • n=3 Participants
|
71.8 years
STANDARD_DEVIATION 5.7 • n=3 Participants
|
72.5 years
STANDARD_DEVIATION 5.2 • n=6 Participants
|
72.4 years
STANDARD_DEVIATION 5.8 • n=24 Participants
|
72.8 years
STANDARD_DEVIATION 5.9 • n=15 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=3 Participants
|
61 Participants
n=3 Participants
|
64 Participants
n=6 Participants
|
64 Participants
n=24 Participants
|
253 Participants
n=15 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=15 Participants
|
|
Race/Ethnicity, Customized
Latina/Hispanic
|
2 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
1 Participants
n=24 Participants
|
7 Participants
n=15 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=15 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black or African American
|
26 Participants
n=3 Participants
|
26 Participants
n=3 Participants
|
25 Participants
n=6 Participants
|
23 Participants
n=24 Participants
|
100 Participants
n=15 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
35 Participants
n=3 Participants
|
34 Participants
n=3 Participants
|
34 Participants
n=6 Participants
|
40 Participants
n=24 Participants
|
143 Participants
n=15 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
1 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=24 Participants
|
2 Participants
n=15 Participants
|
|
Highest education level - College graduate
|
44 Participants
n=3 Participants
|
35 Participants
n=3 Participants
|
37 Participants
n=6 Participants
|
35 Participants
n=24 Participants
|
151 Participants
n=15 Participants
|
PRIMARY outcome
Timeframe: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baselinePopulation: Intent to treat analysis
The East Boston Memory Test is a performance-based neurocognitive test. Participants are read a brief story with 12 key elements. The participants are asked to recall elements immediately and again after three-minute delay. Each score (immediate and delayed recall) has a scale of 0-12, with a higher score indicating better cognitive performance. The total score is an average of the two subscores for immediate and delayed recall. The total score has a scale of 0-12, with a higher score indicating better cognitive performance.
Outcome measures
| Measure |
Usual Care
n=64 Participants
Participants in the usual care group do not receive any Mind- or Move-related intervention, and will receive their usual care from their cardiology provider.
|
Mind - BrainHQ Cognitive Training Intervention
n=64 Participants
The Mind intervention uses the evidence-based BrainHQ computerized cognitive training program. BrainHQ focuses on improving memory, attention, sensory function, and working memory, and has demonstrated efficacy in improving memory among healthy older adults and adults with heart failure. BrainHQ is tailored to the individual, and program difficulty automatically progresses based on performance. Training occurs during three 30-minute sessions per week, for a total of 36 hours. Participants will complete the BrainHQ program on an iPad tablet, which will be provided to them.
Mind: See arm description.
|
Move - Lifestyle Physical Activity Intervention
n=61 Participants
The Move intervention is a 24-week evidence-based program based on social cognitive theory. It was originally developed for midlife women and successfully maintained increased physical activity. It has since been tailored for older women with CVD to prevent or delay cognitive decline, and includes: (1) education on the importance of lifestyle physical activity for brain health, (2) increasing lifestyle physical activity while considering CVD, and (3) including a goal for increasing Fitbit "active" minutes (≥ 3 METs or moderate-intensity physical activity) to ensure participants are obtaining the beneficial aerobic fitness effects during periods of lifestyle physical activity. Core elements include a personal lifestyle physical activity goal and five group meetings.
Move: See arm description.
|
MindMoves - Cognitive Training and Lifestyle Physical Activity
n=64 Participants
Participants who are assigned to this condition will complete both the Move lifestyle physical activity program and the Mind BrainHQ cognitive training intervention simultaneously for 24 weeks (see Move and Mind descriptions). Participants will receive both a Fitbit and iPad tablet to complete the combined MindMoves intervention.
Mind: See arm description.
Move: See arm description.
|
|---|---|---|---|---|
|
Change in East Boston Memory Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
Change from baseline to 24 weeks
|
0.05 score on a scale
Standard Error 0.13
|
0.03 score on a scale
Standard Error 0.13
|
-0.02 score on a scale
Standard Error 0.13
|
0.01 score on a scale
Standard Error 0.13
|
|
Change in East Boston Memory Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
Change from baseline to 48 weeks
|
0.06 score on a scale
Standard Error 0.13
|
0.00 score on a scale
Standard Error 0.13
|
0.04 score on a scale
Standard Error 0.13
|
0.28 score on a scale
Standard Error 0.13
|
|
Change in East Boston Memory Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
Change from baseline to 72 weeks
|
0.23 score on a scale
Standard Error 0.13
|
0.07 score on a scale
Standard Error 0.13
|
0.15 score on a scale
Standard Error 0.13
|
0.03 score on a scale
Standard Error 0.13
|
PRIMARY outcome
Timeframe: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baselinePopulation: Intent to treat analysis
The Category Fluency Test is a performance-based neurocognitive test. Participants are asked to generate examples for two semantic categories (animals, fruits/vegetables) in separate 60-second trials. There are two separate scores (number of animals generated, number of fruits/vegetables generated). A minimum possible score is 0, with an infinite possible maximum score, with a higher score indicating better cognitive performance.
Outcome measures
| Measure |
Usual Care
n=64 Participants
Participants in the usual care group do not receive any Mind- or Move-related intervention, and will receive their usual care from their cardiology provider.
|
Mind - BrainHQ Cognitive Training Intervention
n=64 Participants
The Mind intervention uses the evidence-based BrainHQ computerized cognitive training program. BrainHQ focuses on improving memory, attention, sensory function, and working memory, and has demonstrated efficacy in improving memory among healthy older adults and adults with heart failure. BrainHQ is tailored to the individual, and program difficulty automatically progresses based on performance. Training occurs during three 30-minute sessions per week, for a total of 36 hours. Participants will complete the BrainHQ program on an iPad tablet, which will be provided to them.
Mind: See arm description.
|
Move - Lifestyle Physical Activity Intervention
n=61 Participants
The Move intervention is a 24-week evidence-based program based on social cognitive theory. It was originally developed for midlife women and successfully maintained increased physical activity. It has since been tailored for older women with CVD to prevent or delay cognitive decline, and includes: (1) education on the importance of lifestyle physical activity for brain health, (2) increasing lifestyle physical activity while considering CVD, and (3) including a goal for increasing Fitbit "active" minutes (≥ 3 METs or moderate-intensity physical activity) to ensure participants are obtaining the beneficial aerobic fitness effects during periods of lifestyle physical activity. Core elements include a personal lifestyle physical activity goal and five group meetings.
Move: See arm description.
|
MindMoves - Cognitive Training and Lifestyle Physical Activity
n=64 Participants
Participants who are assigned to this condition will complete both the Move lifestyle physical activity program and the Mind BrainHQ cognitive training intervention simultaneously for 24 weeks (see Move and Mind descriptions). Participants will receive both a Fitbit and iPad tablet to complete the combined MindMoves intervention.
Mind: See arm description.
Move: See arm description.
|
|---|---|---|---|---|
|
Change in Category Fluency Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
Change from baseline to 72 weeks
|
0.09 score on a scale
Standard Error 0.08
|
0.04 score on a scale
Standard Error 0.08
|
0.09 score on a scale
Standard Error 0.08
|
-0.05 score on a scale
Standard Error 0.09
|
|
Change in Category Fluency Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
Change from baseline to 24 weeks
|
0.18 score on a scale
Standard Error 0.08
|
-0.08 score on a scale
Standard Error 0.08
|
0.03 score on a scale
Standard Error 0.08
|
0.04 score on a scale
Standard Error 0.08
|
|
Change in Category Fluency Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
Change from baseline to 48 weeks
|
0.03 score on a scale
Standard Error 0.08
|
0.09 score on a scale
Standard Error 0.08
|
0.06 score on a scale
Standard Error 0.08
|
0.08 score on a scale
Standard Error 0.09
|
PRIMARY outcome
Timeframe: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baselinePopulation: Intent to treat analysis
The Digit Span Forwards and Backwards Test is a performance-based neurocognitive test. The examiner says a string of numbers (digit span). For Digit Span Forwards, participant recites digit span, gradually increasing in length. Test stops when participant fails to recite digit span of same length twice. For Digit Span Backwards, participant recites digit span backwards. There are two separate scores (Digit Span Forwards correct responses, Digit Span Backwards correct responses). Digit Span Forwards scores can range from 0-16, with higher scores indicating higher cognitive performance. Digit Span Backwards Scores range from 0-14, with higher scores indicating higher cognitive performance. A total score is a sum of the two scores, with a range of 0-30, with higher scores indicating higher cognitive performance.
Outcome measures
| Measure |
Usual Care
n=64 Participants
Participants in the usual care group do not receive any Mind- or Move-related intervention, and will receive their usual care from their cardiology provider.
|
Mind - BrainHQ Cognitive Training Intervention
n=64 Participants
The Mind intervention uses the evidence-based BrainHQ computerized cognitive training program. BrainHQ focuses on improving memory, attention, sensory function, and working memory, and has demonstrated efficacy in improving memory among healthy older adults and adults with heart failure. BrainHQ is tailored to the individual, and program difficulty automatically progresses based on performance. Training occurs during three 30-minute sessions per week, for a total of 36 hours. Participants will complete the BrainHQ program on an iPad tablet, which will be provided to them.
Mind: See arm description.
|
Move - Lifestyle Physical Activity Intervention
n=61 Participants
The Move intervention is a 24-week evidence-based program based on social cognitive theory. It was originally developed for midlife women and successfully maintained increased physical activity. It has since been tailored for older women with CVD to prevent or delay cognitive decline, and includes: (1) education on the importance of lifestyle physical activity for brain health, (2) increasing lifestyle physical activity while considering CVD, and (3) including a goal for increasing Fitbit "active" minutes (≥ 3 METs or moderate-intensity physical activity) to ensure participants are obtaining the beneficial aerobic fitness effects during periods of lifestyle physical activity. Core elements include a personal lifestyle physical activity goal and five group meetings.
Move: See arm description.
|
MindMoves - Cognitive Training and Lifestyle Physical Activity
n=64 Participants
Participants who are assigned to this condition will complete both the Move lifestyle physical activity program and the Mind BrainHQ cognitive training intervention simultaneously for 24 weeks (see Move and Mind descriptions). Participants will receive both a Fitbit and iPad tablet to complete the combined MindMoves intervention.
Mind: See arm description.
Move: See arm description.
|
|---|---|---|---|---|
|
Change in Digit Span Forwards and Backwards Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
Change from baseline to 24 weeks
|
-0.12 score on a scale
Standard Error 0.09
|
-0.14 score on a scale
Standard Error 0.09
|
-0.04 score on a scale
Standard Error 0.09
|
-0.01 score on a scale
Standard Error 0.09
|
|
Change in Digit Span Forwards and Backwards Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
Change from baseline to 48 weeks
|
-0.16 score on a scale
Standard Error 0.09
|
0.02 score on a scale
Standard Error 0.09
|
0.12 score on a scale
Standard Error 0.09
|
0.19 score on a scale
Standard Error 0.10
|
|
Change in Digit Span Forwards and Backwards Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
Change from baseline to 72 weeks
|
-0.06 score on a scale
Standard Error 0.09
|
0.06 score on a scale
Standard Error 0.10
|
0.18 score on a scale
Standard Error 0.09
|
-0.08 score on a scale
Standard Error 0.10
|
PRIMARY outcome
Timeframe: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baselinePopulation: Intent to treat analysis
First, participants are asked to count from 1 to 25 (Part A). For Part B, the person is asked to verbally recite alternating numbers and letters until they reach 13 and the letter M. The possible scores is a combined time to completion of both Part A and B summed. Possible minimum score is "discontinued" due to failure to complete the test (a zero score). The maximum score is 300 seconds. A lower score (fewer seconds) indicates higher cognitive performance.
Outcome measures
| Measure |
Usual Care
n=64 Participants
Participants in the usual care group do not receive any Mind- or Move-related intervention, and will receive their usual care from their cardiology provider.
|
Mind - BrainHQ Cognitive Training Intervention
n=64 Participants
The Mind intervention uses the evidence-based BrainHQ computerized cognitive training program. BrainHQ focuses on improving memory, attention, sensory function, and working memory, and has demonstrated efficacy in improving memory among healthy older adults and adults with heart failure. BrainHQ is tailored to the individual, and program difficulty automatically progresses based on performance. Training occurs during three 30-minute sessions per week, for a total of 36 hours. Participants will complete the BrainHQ program on an iPad tablet, which will be provided to them.
Mind: See arm description.
|
Move - Lifestyle Physical Activity Intervention
n=61 Participants
The Move intervention is a 24-week evidence-based program based on social cognitive theory. It was originally developed for midlife women and successfully maintained increased physical activity. It has since been tailored for older women with CVD to prevent or delay cognitive decline, and includes: (1) education on the importance of lifestyle physical activity for brain health, (2) increasing lifestyle physical activity while considering CVD, and (3) including a goal for increasing Fitbit "active" minutes (≥ 3 METs or moderate-intensity physical activity) to ensure participants are obtaining the beneficial aerobic fitness effects during periods of lifestyle physical activity. Core elements include a personal lifestyle physical activity goal and five group meetings.
Move: See arm description.
|
MindMoves - Cognitive Training and Lifestyle Physical Activity
n=64 Participants
Participants who are assigned to this condition will complete both the Move lifestyle physical activity program and the Mind BrainHQ cognitive training intervention simultaneously for 24 weeks (see Move and Mind descriptions). Participants will receive both a Fitbit and iPad tablet to complete the combined MindMoves intervention.
Mind: See arm description.
Move: See arm description.
|
|---|---|---|---|---|
|
Change in Oral Trails A/B Tests Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
Change from baseline to 24 weeks
|
0.17 seconds
Standard Error 0.12
|
0.29 seconds
Standard Error 0.12
|
0.12 seconds
Standard Error 0.12
|
0.14 seconds
Standard Error 0.12
|
|
Change in Oral Trails A/B Tests Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
Change from baseline to 48 weeks
|
0.22 seconds
Standard Error 0.12
|
0.40 seconds
Standard Error 0.12
|
0.06 seconds
Standard Error 0.12
|
0.09 seconds
Standard Error 0.12
|
|
Change in Oral Trails A/B Tests Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
Change from baseline to 72 weeks
|
0.23 seconds
Standard Error 0.12
|
0.24 seconds
Standard Error 0.12
|
0.29 seconds
Standard Error 0.12
|
0.28 seconds
Standard Error 0.12
|
PRIMARY outcome
Timeframe: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baselinePopulation: intent to treat analysis
Participants are asked to memorize and immediately recall in ascending order a series of numbers that gradually increase in length with each trial. Possible scores range from 0-16, with a higher score indicating higher cognitive performance.
Outcome measures
| Measure |
Usual Care
n=64 Participants
Participants in the usual care group do not receive any Mind- or Move-related intervention, and will receive their usual care from their cardiology provider.
|
Mind - BrainHQ Cognitive Training Intervention
n=64 Participants
The Mind intervention uses the evidence-based BrainHQ computerized cognitive training program. BrainHQ focuses on improving memory, attention, sensory function, and working memory, and has demonstrated efficacy in improving memory among healthy older adults and adults with heart failure. BrainHQ is tailored to the individual, and program difficulty automatically progresses based on performance. Training occurs during three 30-minute sessions per week, for a total of 36 hours. Participants will complete the BrainHQ program on an iPad tablet, which will be provided to them.
Mind: See arm description.
|
Move - Lifestyle Physical Activity Intervention
n=61 Participants
The Move intervention is a 24-week evidence-based program based on social cognitive theory. It was originally developed for midlife women and successfully maintained increased physical activity. It has since been tailored for older women with CVD to prevent or delay cognitive decline, and includes: (1) education on the importance of lifestyle physical activity for brain health, (2) increasing lifestyle physical activity while considering CVD, and (3) including a goal for increasing Fitbit "active" minutes (≥ 3 METs or moderate-intensity physical activity) to ensure participants are obtaining the beneficial aerobic fitness effects during periods of lifestyle physical activity. Core elements include a personal lifestyle physical activity goal and five group meetings.
Move: See arm description.
|
MindMoves - Cognitive Training and Lifestyle Physical Activity
n=64 Participants
Participants who are assigned to this condition will complete both the Move lifestyle physical activity program and the Mind BrainHQ cognitive training intervention simultaneously for 24 weeks (see Move and Mind descriptions). Participants will receive both a Fitbit and iPad tablet to complete the combined MindMoves intervention.
Mind: See arm description.
Move: See arm description.
|
|---|---|---|---|---|
|
Change in Digit Ordering Tests Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
Change from baseline to 48 weeks
|
-0.16 score on a scale
Standard Error 0.09
|
0.02 score on a scale
Standard Error 0.09
|
0.12 score on a scale
Standard Error 0.09
|
0.19 score on a scale
Standard Error 0.10
|
|
Change in Digit Ordering Tests Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
Change from baseline to 72 weeks
|
-0.06 score on a scale
Standard Error 0.09
|
-0.06 score on a scale
Standard Error 0.10
|
0.18 score on a scale
Standard Error 0.09
|
-0.08 score on a scale
Standard Error 0.10
|
|
Change in Digit Ordering Tests Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
Change from baseline to 24 weeks
|
-0.12 score on a scale
Standard Error 0.09
|
-0.14 score on a scale
Standard Error 0.09
|
-0.04 score on a scale
Standard Error 0.09
|
-0.01 score on a scale
Standard Error 0.09
|
SECONDARY outcome
Timeframe: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baselineWe will obtain blood samples for BDNF. Pretreatment serum or plasma specimens will be prepared using standard techniques and archived at -80°C in aliquots with no specimen subjected to more than two freeze-thaw cycles. All assays performed in a blinded fashion and according to manufacturer's protocol using a 384-well modified method. Luminex FlexMAP 3D will be used with concentrations calculated based on 7-pt standard curves using a 5-parametric fit algorithm in xPONENT v4.0.3. Following recommendations, serum biomarkers will be obtained in the morning (8am-10am) following an 8-hour fast.
Outcome measures
| Measure |
Usual Care
n=64 Participants
Participants in the usual care group do not receive any Mind- or Move-related intervention, and will receive their usual care from their cardiology provider.
|
Mind - BrainHQ Cognitive Training Intervention
n=64 Participants
The Mind intervention uses the evidence-based BrainHQ computerized cognitive training program. BrainHQ focuses on improving memory, attention, sensory function, and working memory, and has demonstrated efficacy in improving memory among healthy older adults and adults with heart failure. BrainHQ is tailored to the individual, and program difficulty automatically progresses based on performance. Training occurs during three 30-minute sessions per week, for a total of 36 hours. Participants will complete the BrainHQ program on an iPad tablet, which will be provided to them.
Mind: See arm description.
|
Move - Lifestyle Physical Activity Intervention
n=61 Participants
The Move intervention is a 24-week evidence-based program based on social cognitive theory. It was originally developed for midlife women and successfully maintained increased physical activity. It has since been tailored for older women with CVD to prevent or delay cognitive decline, and includes: (1) education on the importance of lifestyle physical activity for brain health, (2) increasing lifestyle physical activity while considering CVD, and (3) including a goal for increasing Fitbit "active" minutes (≥ 3 METs or moderate-intensity physical activity) to ensure participants are obtaining the beneficial aerobic fitness effects during periods of lifestyle physical activity. Core elements include a personal lifestyle physical activity goal and five group meetings.
Move: See arm description.
|
MindMoves - Cognitive Training and Lifestyle Physical Activity
n=64 Participants
Participants who are assigned to this condition will complete both the Move lifestyle physical activity program and the Mind BrainHQ cognitive training intervention simultaneously for 24 weeks (see Move and Mind descriptions). Participants will receive both a Fitbit and iPad tablet to complete the combined MindMoves intervention.
Mind: See arm description.
Move: See arm description.
|
|---|---|---|---|---|
|
Change in Brain-derived Neurotrophic Factor (BDNF) Levels From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
Change from baseline to 24 weeks
|
.05 log-transformed pg/mL
Standard Error .04
|
.01 log-transformed pg/mL
Standard Error .04
|
.05 log-transformed pg/mL
Standard Error .04
|
.05 log-transformed pg/mL
Standard Error .04
|
|
Change in Brain-derived Neurotrophic Factor (BDNF) Levels From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
Change from baseline to 48 weeks
|
.05 log-transformed pg/mL
Standard Error .04
|
.05 log-transformed pg/mL
Standard Error .04
|
.05 log-transformed pg/mL
Standard Error .04
|
.06 log-transformed pg/mL
Standard Error .04
|
|
Change in Brain-derived Neurotrophic Factor (BDNF) Levels From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
Change from baseline to 72 weeks
|
.05 log-transformed pg/mL
Standard Error .04
|
.01 log-transformed pg/mL
Standard Error .04
|
.05 log-transformed pg/mL
Standard Error .04
|
-.01 log-transformed pg/mL
Standard Error .04
|
SECONDARY outcome
Timeframe: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baselineWe will obtain blood samples for VEGF. Pretreatment serum or plasma specimens will be prepared using standard techniques and archived at -80°C in aliquots with no specimen subjected to more than two freeze-thaw cycles. All assays performed in a blinded fashion and according to manufacturer's protocol using a 384-well modified method. Luminex FlexMAP 3D will be used with concentrations calculated based on 7-pt standard curves using a 5-parametric fit algorithm in xPONENT v4.0.3. Following recommendations, serum biomarkers will be obtained in the morning (8am-10am) following an 8-hour fast.
Outcome measures
| Measure |
Usual Care
n=64 Participants
Participants in the usual care group do not receive any Mind- or Move-related intervention, and will receive their usual care from their cardiology provider.
|
Mind - BrainHQ Cognitive Training Intervention
n=64 Participants
The Mind intervention uses the evidence-based BrainHQ computerized cognitive training program. BrainHQ focuses on improving memory, attention, sensory function, and working memory, and has demonstrated efficacy in improving memory among healthy older adults and adults with heart failure. BrainHQ is tailored to the individual, and program difficulty automatically progresses based on performance. Training occurs during three 30-minute sessions per week, for a total of 36 hours. Participants will complete the BrainHQ program on an iPad tablet, which will be provided to them.
Mind: See arm description.
|
Move - Lifestyle Physical Activity Intervention
n=61 Participants
The Move intervention is a 24-week evidence-based program based on social cognitive theory. It was originally developed for midlife women and successfully maintained increased physical activity. It has since been tailored for older women with CVD to prevent or delay cognitive decline, and includes: (1) education on the importance of lifestyle physical activity for brain health, (2) increasing lifestyle physical activity while considering CVD, and (3) including a goal for increasing Fitbit "active" minutes (≥ 3 METs or moderate-intensity physical activity) to ensure participants are obtaining the beneficial aerobic fitness effects during periods of lifestyle physical activity. Core elements include a personal lifestyle physical activity goal and five group meetings.
Move: See arm description.
|
MindMoves - Cognitive Training and Lifestyle Physical Activity
n=64 Participants
Participants who are assigned to this condition will complete both the Move lifestyle physical activity program and the Mind BrainHQ cognitive training intervention simultaneously for 24 weeks (see Move and Mind descriptions). Participants will receive both a Fitbit and iPad tablet to complete the combined MindMoves intervention.
Mind: See arm description.
Move: See arm description.
|
|---|---|---|---|---|
|
Change in Vascular Endothelial Growth Factor A (VEGF) Levels From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
Change from baseline to 24 weeks
|
.00 log-transformed pg/mL
Standard Error .03
|
.02 log-transformed pg/mL
Standard Error .03
|
.03 log-transformed pg/mL
Standard Error .03
|
-.05 log-transformed pg/mL
Standard Error .03
|
|
Change in Vascular Endothelial Growth Factor A (VEGF) Levels From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
Change from baseline to 48 weeks
|
.03 log-transformed pg/mL
Standard Error .03
|
.06 log-transformed pg/mL
Standard Error .03
|
.00 log-transformed pg/mL
Standard Error .03
|
.03 log-transformed pg/mL
Standard Error .03
|
|
Change in Vascular Endothelial Growth Factor A (VEGF) Levels From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
Change from baseline to 72 weeks
|
-.03 log-transformed pg/mL
Standard Error .03
|
.02 log-transformed pg/mL
Standard Error .03
|
-.03 log-transformed pg/mL
Standard Error .03
|
.03 log-transformed pg/mL
Standard Error .03
|
SECONDARY outcome
Timeframe: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baselineWe will obtain blood samples for IGF-1. Pretreatment serum or plasma specimens will be prepared using standard techniques and archived at -80°C in aliquots with no specimen subjected to more than two freeze-thaw cycles. All assays performed in a blinded fashion and according to manufacturer's protocol using a 384-well modified method. Luminex FlexMAP 3D will be used with concentrations calculated based on 7-pt standard curves using a 5-parametric fit algorithm in xPONENT v4.0.3. Following recommendations, serum biomarkers will be obtained in the morning (8am-10am) following an 8-hour fast.
Outcome measures
| Measure |
Usual Care
n=64 Participants
Participants in the usual care group do not receive any Mind- or Move-related intervention, and will receive their usual care from their cardiology provider.
|
Mind - BrainHQ Cognitive Training Intervention
n=64 Participants
The Mind intervention uses the evidence-based BrainHQ computerized cognitive training program. BrainHQ focuses on improving memory, attention, sensory function, and working memory, and has demonstrated efficacy in improving memory among healthy older adults and adults with heart failure. BrainHQ is tailored to the individual, and program difficulty automatically progresses based on performance. Training occurs during three 30-minute sessions per week, for a total of 36 hours. Participants will complete the BrainHQ program on an iPad tablet, which will be provided to them.
Mind: See arm description.
|
Move - Lifestyle Physical Activity Intervention
n=61 Participants
The Move intervention is a 24-week evidence-based program based on social cognitive theory. It was originally developed for midlife women and successfully maintained increased physical activity. It has since been tailored for older women with CVD to prevent or delay cognitive decline, and includes: (1) education on the importance of lifestyle physical activity for brain health, (2) increasing lifestyle physical activity while considering CVD, and (3) including a goal for increasing Fitbit "active" minutes (≥ 3 METs or moderate-intensity physical activity) to ensure participants are obtaining the beneficial aerobic fitness effects during periods of lifestyle physical activity. Core elements include a personal lifestyle physical activity goal and five group meetings.
Move: See arm description.
|
MindMoves - Cognitive Training and Lifestyle Physical Activity
n=64 Participants
Participants who are assigned to this condition will complete both the Move lifestyle physical activity program and the Mind BrainHQ cognitive training intervention simultaneously for 24 weeks (see Move and Mind descriptions). Participants will receive both a Fitbit and iPad tablet to complete the combined MindMoves intervention.
Mind: See arm description.
Move: See arm description.
|
|---|---|---|---|---|
|
Change in Insulin-like Growth Factor 1 (IGF-1) From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
Change from baseline to 72 weeks
|
2.71 square root transformed pg/mL
Standard Error 5.89
|
7.55 square root transformed pg/mL
Standard Error 5.93
|
4.07 square root transformed pg/mL
Standard Error 5.75
|
-4.42 square root transformed pg/mL
Standard Error 5.97
|
|
Change in Insulin-like Growth Factor 1 (IGF-1) From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
Change from baseline to 24 weeks
|
8.45 square root transformed pg/mL
Standard Error 5.85
|
3.37 square root transformed pg/mL
Standard Error 5.92
|
5.26 square root transformed pg/mL
Standard Error 5.65
|
6.59 square root transformed pg/mL
Standard Error 5.88
|
|
Change in Insulin-like Growth Factor 1 (IGF-1) From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
Change from baseline to 48 weeks
|
-1.52 square root transformed pg/mL
Standard Error 5.89
|
3.25 square root transformed pg/mL
Standard Error 6.05
|
4.24 square root transformed pg/mL
Standard Error 5.79
|
6.40 square root transformed pg/mL
Standard Error 6.05
|
SECONDARY outcome
Timeframe: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baselineThe ActiGraph accelerometer is a motion sensor device that provides a valid assessment of physical activity in adult persons during treadmill Moveing/running and daily activity. The accelerometer records vertical accelerations as "counts." Participants are instructed to wear on the hip for seven consecutive days during waking hours only, except while swimming or bathing. To analyze the accelerometer data, we will use the following physical activity intensity cut points: light 100-1,565 counts/min (\< 3 METS \[metabolic equivalent of task\]); moderate 1,566-6,139 (3.0-6.0 METS); vigorous ≥ 6,140 (≥ 6.1 METS). Findings are reported in mean daily minutes of moderate-vigorous physical activity
Outcome measures
| Measure |
Usual Care
n=64 Participants
Participants in the usual care group do not receive any Mind- or Move-related intervention, and will receive their usual care from their cardiology provider.
|
Mind - BrainHQ Cognitive Training Intervention
n=64 Participants
The Mind intervention uses the evidence-based BrainHQ computerized cognitive training program. BrainHQ focuses on improving memory, attention, sensory function, and working memory, and has demonstrated efficacy in improving memory among healthy older adults and adults with heart failure. BrainHQ is tailored to the individual, and program difficulty automatically progresses based on performance. Training occurs during three 30-minute sessions per week, for a total of 36 hours. Participants will complete the BrainHQ program on an iPad tablet, which will be provided to them.
Mind: See arm description.
|
Move - Lifestyle Physical Activity Intervention
n=61 Participants
The Move intervention is a 24-week evidence-based program based on social cognitive theory. It was originally developed for midlife women and successfully maintained increased physical activity. It has since been tailored for older women with CVD to prevent or delay cognitive decline, and includes: (1) education on the importance of lifestyle physical activity for brain health, (2) increasing lifestyle physical activity while considering CVD, and (3) including a goal for increasing Fitbit "active" minutes (≥ 3 METs or moderate-intensity physical activity) to ensure participants are obtaining the beneficial aerobic fitness effects during periods of lifestyle physical activity. Core elements include a personal lifestyle physical activity goal and five group meetings.
Move: See arm description.
|
MindMoves - Cognitive Training and Lifestyle Physical Activity
n=64 Participants
Participants who are assigned to this condition will complete both the Move lifestyle physical activity program and the Mind BrainHQ cognitive training intervention simultaneously for 24 weeks (see Move and Mind descriptions). Participants will receive both a Fitbit and iPad tablet to complete the combined MindMoves intervention.
Mind: See arm description.
Move: See arm description.
|
|---|---|---|---|---|
|
Change in GT3XE-Plus Triaxial Accelerometer Minutes of Moderate Vigorous Physical Activity From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
Change from baseline to 24 weeks
|
.11 log-transformed minutes
Standard Error .10
|
-.10 log-transformed minutes
Standard Error .10
|
.03 log-transformed minutes
Standard Error .09
|
.06 log-transformed minutes
Standard Error .10
|
|
Change in GT3XE-Plus Triaxial Accelerometer Minutes of Moderate Vigorous Physical Activity From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
Change from baseline to 48 weeks
|
-.17 log-transformed minutes
Standard Error .09
|
-.13 log-transformed minutes
Standard Error .10
|
-.13 log-transformed minutes
Standard Error .09
|
-.10 log-transformed minutes
Standard Error .10
|
|
Change in GT3XE-Plus Triaxial Accelerometer Minutes of Moderate Vigorous Physical Activity From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
Change from baseline to 72 weeks
|
.03 log-transformed minutes
Standard Error .10
|
-.13 log-transformed minutes
Standard Error .10
|
-.18 log-transformed minutes
Standard Error .09
|
-.12 log-transformed minutes
Standard Error .10
|
SECONDARY outcome
Timeframe: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baselineThis is a test of aerobic fitness that can be performed in a small space using minimal equipment. Participants step in place to a predesignated height for two minutes. This test is correlated with treadmill tests of aerobic fitness. The score is number of valid steps achieved reaching the predesignated height in two minutes.
Outcome measures
| Measure |
Usual Care
n=64 Participants
Participants in the usual care group do not receive any Mind- or Move-related intervention, and will receive their usual care from their cardiology provider.
|
Mind - BrainHQ Cognitive Training Intervention
n=64 Participants
The Mind intervention uses the evidence-based BrainHQ computerized cognitive training program. BrainHQ focuses on improving memory, attention, sensory function, and working memory, and has demonstrated efficacy in improving memory among healthy older adults and adults with heart failure. BrainHQ is tailored to the individual, and program difficulty automatically progresses based on performance. Training occurs during three 30-minute sessions per week, for a total of 36 hours. Participants will complete the BrainHQ program on an iPad tablet, which will be provided to them.
Mind: See arm description.
|
Move - Lifestyle Physical Activity Intervention
n=61 Participants
The Move intervention is a 24-week evidence-based program based on social cognitive theory. It was originally developed for midlife women and successfully maintained increased physical activity. It has since been tailored for older women with CVD to prevent or delay cognitive decline, and includes: (1) education on the importance of lifestyle physical activity for brain health, (2) increasing lifestyle physical activity while considering CVD, and (3) including a goal for increasing Fitbit "active" minutes (≥ 3 METs or moderate-intensity physical activity) to ensure participants are obtaining the beneficial aerobic fitness effects during periods of lifestyle physical activity. Core elements include a personal lifestyle physical activity goal and five group meetings.
Move: See arm description.
|
MindMoves - Cognitive Training and Lifestyle Physical Activity
n=64 Participants
Participants who are assigned to this condition will complete both the Move lifestyle physical activity program and the Mind BrainHQ cognitive training intervention simultaneously for 24 weeks (see Move and Mind descriptions). Participants will receive both a Fitbit and iPad tablet to complete the combined MindMoves intervention.
Mind: See arm description.
Move: See arm description.
|
|---|---|---|---|---|
|
Change in the Two-minute Step Test of Aerobic Fitness Score From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
Change from baseline to 24 weeks
|
-5.10 steps
Standard Error 2.35
|
-3.52 steps
Standard Error 2.38
|
-2.71 steps
Standard Error 2.27
|
-2.69 steps
Standard Error 2.34
|
|
Change in the Two-minute Step Test of Aerobic Fitness Score From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
Change from baseline to 48 weeks
|
-9.46 steps
Standard Error 2.32
|
-3.33 steps
Standard Error 2.44
|
-2.33 steps
Standard Error 2.31
|
-5.64 steps
Standard Error 2.42
|
|
Change in the Two-minute Step Test of Aerobic Fitness Score From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
Change from baseline to 72 weeks
|
-5.16 steps
Standard Error 2.33
|
-5.42 steps
Standard Error 2.42
|
-2.15 steps
Standard Error 2.31
|
-7.04 steps
Standard Error 2.34
|
SECONDARY outcome
Timeframe: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baselineThe Community Health Activities Model Program for Seniors (CHAMPS) is a 30-item self-report questionnaire that assesses the leisure time, household, and transportation physical activity in past two weeks. Participants are asked how long they participate in 30 different activities and at what frequency. Each activity is assigned intensity. Scores include mean minutes per week of light and moderate-vigorous physical activity for both leisure time and household scales (minimum score of 0 minutes and maximum score of 24 hours, with higher scores indicating more time spent in physical activity).
Outcome measures
| Measure |
Usual Care
n=64 Participants
Participants in the usual care group do not receive any Mind- or Move-related intervention, and will receive their usual care from their cardiology provider.
|
Mind - BrainHQ Cognitive Training Intervention
n=64 Participants
The Mind intervention uses the evidence-based BrainHQ computerized cognitive training program. BrainHQ focuses on improving memory, attention, sensory function, and working memory, and has demonstrated efficacy in improving memory among healthy older adults and adults with heart failure. BrainHQ is tailored to the individual, and program difficulty automatically progresses based on performance. Training occurs during three 30-minute sessions per week, for a total of 36 hours. Participants will complete the BrainHQ program on an iPad tablet, which will be provided to them.
Mind: See arm description.
|
Move - Lifestyle Physical Activity Intervention
n=61 Participants
The Move intervention is a 24-week evidence-based program based on social cognitive theory. It was originally developed for midlife women and successfully maintained increased physical activity. It has since been tailored for older women with CVD to prevent or delay cognitive decline, and includes: (1) education on the importance of lifestyle physical activity for brain health, (2) increasing lifestyle physical activity while considering CVD, and (3) including a goal for increasing Fitbit "active" minutes (≥ 3 METs or moderate-intensity physical activity) to ensure participants are obtaining the beneficial aerobic fitness effects during periods of lifestyle physical activity. Core elements include a personal lifestyle physical activity goal and five group meetings.
Move: See arm description.
|
MindMoves - Cognitive Training and Lifestyle Physical Activity
n=64 Participants
Participants who are assigned to this condition will complete both the Move lifestyle physical activity program and the Mind BrainHQ cognitive training intervention simultaneously for 24 weeks (see Move and Mind descriptions). Participants will receive both a Fitbit and iPad tablet to complete the combined MindMoves intervention.
Mind: See arm description.
Move: See arm description.
|
|---|---|---|---|---|
|
Change in Self-reported Physical Activity as Assessed by the Community Healthy Activities Model Program for Seniors (CHAMPS) Survey From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
Change from baseline to 24 weeks
|
.26 log-transformed hours
Standard Error .11
|
.36 log-transformed hours
Standard Error .11
|
.32 log-transformed hours
Standard Error .11
|
.21 log-transformed hours
Standard Error .11
|
|
Change in Self-reported Physical Activity as Assessed by the Community Healthy Activities Model Program for Seniors (CHAMPS) Survey From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
Change from baseline to 48 weeks
|
.28 log-transformed hours
Standard Error .11
|
.40 log-transformed hours
Standard Error .11
|
.36 log-transformed hours
Standard Error .11
|
.21 log-transformed hours
Standard Error .12
|
|
Change in Self-reported Physical Activity as Assessed by the Community Healthy Activities Model Program for Seniors (CHAMPS) Survey From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
Change from baseline to 72 weeks
|
.44 log-transformed hours
Standard Error .11
|
.48 log-transformed hours
Standard Error .12
|
.46 log-transformed hours
Standard Error .11
|
.45 log-transformed hours
Standard Error .12
|
SECONDARY outcome
Timeframe: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baselineSelf-report cognitive activity is a self-report questionnaire of participation in nine activities that involve information processing with minimal physical or social demands. Participants rate on a five-point scale. The score is an average of nine items (minimum score of 9, maximum score of 54 with higher scores indicating higher self-reported levels of cognitive activity).
Outcome measures
| Measure |
Usual Care
n=64 Participants
Participants in the usual care group do not receive any Mind- or Move-related intervention, and will receive their usual care from their cardiology provider.
|
Mind - BrainHQ Cognitive Training Intervention
n=64 Participants
The Mind intervention uses the evidence-based BrainHQ computerized cognitive training program. BrainHQ focuses on improving memory, attention, sensory function, and working memory, and has demonstrated efficacy in improving memory among healthy older adults and adults with heart failure. BrainHQ is tailored to the individual, and program difficulty automatically progresses based on performance. Training occurs during three 30-minute sessions per week, for a total of 36 hours. Participants will complete the BrainHQ program on an iPad tablet, which will be provided to them.
Mind: See arm description.
|
Move - Lifestyle Physical Activity Intervention
n=61 Participants
The Move intervention is a 24-week evidence-based program based on social cognitive theory. It was originally developed for midlife women and successfully maintained increased physical activity. It has since been tailored for older women with CVD to prevent or delay cognitive decline, and includes: (1) education on the importance of lifestyle physical activity for brain health, (2) increasing lifestyle physical activity while considering CVD, and (3) including a goal for increasing Fitbit "active" minutes (≥ 3 METs or moderate-intensity physical activity) to ensure participants are obtaining the beneficial aerobic fitness effects during periods of lifestyle physical activity. Core elements include a personal lifestyle physical activity goal and five group meetings.
Move: See arm description.
|
MindMoves - Cognitive Training and Lifestyle Physical Activity
n=64 Participants
Participants who are assigned to this condition will complete both the Move lifestyle physical activity program and the Mind BrainHQ cognitive training intervention simultaneously for 24 weeks (see Move and Mind descriptions). Participants will receive both a Fitbit and iPad tablet to complete the combined MindMoves intervention.
Mind: See arm description.
Move: See arm description.
|
|---|---|---|---|---|
|
Change in Self-reported Cognitive Activity From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
Change from baseline to 72 weeks
|
.13 score on a scale
Standard Error .07
|
-.10 score on a scale
Standard Error .07
|
.21 score on a scale
Standard Error .07
|
.12 score on a scale
Standard Error .07
|
|
Change in Self-reported Cognitive Activity From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
Change from baseline to 24 weeks
|
.02 score on a scale
Standard Error .07
|
.03 score on a scale
Standard Error .07
|
.15 score on a scale
Standard Error .07
|
.08 score on a scale
Standard Error .07
|
|
Change in Self-reported Cognitive Activity From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
Change from baseline to 48 weeks
|
.03 score on a scale
Standard Error .07
|
.01 score on a scale
Standard Error .07
|
.21 score on a scale
Standard Error .07
|
-.04 score on a scale
Standard Error .07
|
SECONDARY outcome
Timeframe: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baselineThe ActiGraph accelerometer is a motion sensor device that provides a valid assessment of physical activity in adult persons during treadmill Moveing/running and daily activity. The accelerometer records vertical accelerations as "counts." Participants are instructed to wear on the hip for seven consecutive days during waking hours only, except while swimming or bathing. To analyze the accelerometer data, we will use the following physical activity intensity cut points: light 100-1,565 counts/min (\< 3 METS \[metabolic equivalent of task\]); moderate 1,566-6,139 (3.0-6.0 METS); vigorous ≥ 6,140 (≥ 6.1 METS). Findings are reported in mean daily minutes of light physical activity
Outcome measures
| Measure |
Usual Care
n=64 Participants
Participants in the usual care group do not receive any Mind- or Move-related intervention, and will receive their usual care from their cardiology provider.
|
Mind - BrainHQ Cognitive Training Intervention
n=64 Participants
The Mind intervention uses the evidence-based BrainHQ computerized cognitive training program. BrainHQ focuses on improving memory, attention, sensory function, and working memory, and has demonstrated efficacy in improving memory among healthy older adults and adults with heart failure. BrainHQ is tailored to the individual, and program difficulty automatically progresses based on performance. Training occurs during three 30-minute sessions per week, for a total of 36 hours. Participants will complete the BrainHQ program on an iPad tablet, which will be provided to them.
Mind: See arm description.
|
Move - Lifestyle Physical Activity Intervention
n=61 Participants
The Move intervention is a 24-week evidence-based program based on social cognitive theory. It was originally developed for midlife women and successfully maintained increased physical activity. It has since been tailored for older women with CVD to prevent or delay cognitive decline, and includes: (1) education on the importance of lifestyle physical activity for brain health, (2) increasing lifestyle physical activity while considering CVD, and (3) including a goal for increasing Fitbit "active" minutes (≥ 3 METs or moderate-intensity physical activity) to ensure participants are obtaining the beneficial aerobic fitness effects during periods of lifestyle physical activity. Core elements include a personal lifestyle physical activity goal and five group meetings.
Move: See arm description.
|
MindMoves - Cognitive Training and Lifestyle Physical Activity
n=64 Participants
Participants who are assigned to this condition will complete both the Move lifestyle physical activity program and the Mind BrainHQ cognitive training intervention simultaneously for 24 weeks (see Move and Mind descriptions). Participants will receive both a Fitbit and iPad tablet to complete the combined MindMoves intervention.
Mind: See arm description.
Move: See arm description.
|
|---|---|---|---|---|
|
Change in GT3XE-Plus Triaxial Accelerometer Minutes of Light Physical Activity From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
Change from baseline to 24 weeks
|
.09 daily minutes
Standard Error 6.99
|
-10.04 daily minutes
Standard Error 6.96
|
2.83 daily minutes
Standard Error 6.76
|
2.13 daily minutes
Standard Error 7.13
|
|
Change in GT3XE-Plus Triaxial Accelerometer Minutes of Light Physical Activity From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
Change from baseline to 48 weeks
|
-3.47 daily minutes
Standard Error 6.85
|
6.62 daily minutes
Standard Error 7.32
|
-12.49 daily minutes
Standard Error 6.80
|
-3.84 daily minutes
Standard Error 7.49
|
|
Change in GT3XE-Plus Triaxial Accelerometer Minutes of Light Physical Activity From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
Change from baseline to 72 weeks
|
-3.21 daily minutes
Standard Error 7.13
|
2.46 daily minutes
Standard Error 7.18
|
-6.40 daily minutes
Standard Error 6.76
|
-8.08 daily minutes
Standard Error 7.22
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baselineDepressive symptoms will be evaluated as a potential moderator. The Center for Epidemiologic Studies-Depression Scale (20 items scored 0-3) assesses symptoms of depressed mood, feelings of guilt and worthlessness, feelings of helplessness and hopelessness, psychomotor retardation, loss of appetite, and sleep disturbance. Participants who score ≥ 16 will be referred to their primary/ psychiatric provider for further evaluation and treatment. Scores range from 0-60, with higher score indicating more depressive symptoms.
Outcome measures
| Measure |
Usual Care
n=64 Participants
Participants in the usual care group do not receive any Mind- or Move-related intervention, and will receive their usual care from their cardiology provider.
|
Mind - BrainHQ Cognitive Training Intervention
n=64 Participants
The Mind intervention uses the evidence-based BrainHQ computerized cognitive training program. BrainHQ focuses on improving memory, attention, sensory function, and working memory, and has demonstrated efficacy in improving memory among healthy older adults and adults with heart failure. BrainHQ is tailored to the individual, and program difficulty automatically progresses based on performance. Training occurs during three 30-minute sessions per week, for a total of 36 hours. Participants will complete the BrainHQ program on an iPad tablet, which will be provided to them.
Mind: See arm description.
|
Move - Lifestyle Physical Activity Intervention
n=61 Participants
The Move intervention is a 24-week evidence-based program based on social cognitive theory. It was originally developed for midlife women and successfully maintained increased physical activity. It has since been tailored for older women with CVD to prevent or delay cognitive decline, and includes: (1) education on the importance of lifestyle physical activity for brain health, (2) increasing lifestyle physical activity while considering CVD, and (3) including a goal for increasing Fitbit "active" minutes (≥ 3 METs or moderate-intensity physical activity) to ensure participants are obtaining the beneficial aerobic fitness effects during periods of lifestyle physical activity. Core elements include a personal lifestyle physical activity goal and five group meetings.
Move: See arm description.
|
MindMoves - Cognitive Training and Lifestyle Physical Activity
n=64 Participants
Participants who are assigned to this condition will complete both the Move lifestyle physical activity program and the Mind BrainHQ cognitive training intervention simultaneously for 24 weeks (see Move and Mind descriptions). Participants will receive both a Fitbit and iPad tablet to complete the combined MindMoves intervention.
Mind: See arm description.
Move: See arm description.
|
|---|---|---|---|---|
|
Level and Change in Center for Epidemiologic Studies-Depression Scale Score From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks.
Change from baseline to 24 weeks
|
.16 log-transformed score on a scale
Standard Error .11
|
-.07 log-transformed score on a scale
Standard Error .11
|
.09 log-transformed score on a scale
Standard Error .11
|
.00 log-transformed score on a scale
Standard Error .11
|
|
Level and Change in Center for Epidemiologic Studies-Depression Scale Score From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks.
Change from baseline to 48 weeks
|
.07 log-transformed score on a scale
Standard Error .11
|
-.18 log-transformed score on a scale
Standard Error .11
|
-.07 log-transformed score on a scale
Standard Error .11
|
-.05 log-transformed score on a scale
Standard Error .11
|
|
Level and Change in Center for Epidemiologic Studies-Depression Scale Score From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks.
Change from baseline to 72 weeks
|
.00 log-transformed score on a scale
Standard Error .11
|
.02 log-transformed score on a scale
Standard Error .11
|
-.08 log-transformed score on a scale
Standard Error .11
|
-.24 log-transformed score on a scale
Standard Error .11
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: The number of participants analyzed represents the total of number of participants for whom blood was drawn and successfully analyzed to determine APOE genotype.
Potential moderator. Candidate gene analysis with DNA extraction from whole blood samples using an Autogen DNA isolation kit (Qiagen, Venlo, Netherlands). Participants will be characterized by APOE genotype and subdivided into two groups of patients in whom the APOE ε4 allele was absent or present.
Outcome measures
| Measure |
Usual Care
n=63 Participants
Participants in the usual care group do not receive any Mind- or Move-related intervention, and will receive their usual care from their cardiology provider.
|
Mind - BrainHQ Cognitive Training Intervention
n=60 Participants
The Mind intervention uses the evidence-based BrainHQ computerized cognitive training program. BrainHQ focuses on improving memory, attention, sensory function, and working memory, and has demonstrated efficacy in improving memory among healthy older adults and adults with heart failure. BrainHQ is tailored to the individual, and program difficulty automatically progresses based on performance. Training occurs during three 30-minute sessions per week, for a total of 36 hours. Participants will complete the BrainHQ program on an iPad tablet, which will be provided to them.
Mind: See arm description.
|
Move - Lifestyle Physical Activity Intervention
n=60 Participants
The Move intervention is a 24-week evidence-based program based on social cognitive theory. It was originally developed for midlife women and successfully maintained increased physical activity. It has since been tailored for older women with CVD to prevent or delay cognitive decline, and includes: (1) education on the importance of lifestyle physical activity for brain health, (2) increasing lifestyle physical activity while considering CVD, and (3) including a goal for increasing Fitbit "active" minutes (≥ 3 METs or moderate-intensity physical activity) to ensure participants are obtaining the beneficial aerobic fitness effects during periods of lifestyle physical activity. Core elements include a personal lifestyle physical activity goal and five group meetings.
Move: See arm description.
|
MindMoves - Cognitive Training and Lifestyle Physical Activity
n=63 Participants
Participants who are assigned to this condition will complete both the Move lifestyle physical activity program and the Mind BrainHQ cognitive training intervention simultaneously for 24 weeks (see Move and Mind descriptions). Participants will receive both a Fitbit and iPad tablet to complete the combined MindMoves intervention.
Mind: See arm description.
Move: See arm description.
|
|---|---|---|---|---|
|
Apolipoprotein [APOE]- ε4 Allele
Count of participants with APOE ε4 allele present
|
18 Participants
|
10 Participants
|
16 Participants
|
18 Participants
|
|
Apolipoprotein [APOE]- ε4 Allele
Count of participants with APOE ε4 allele absent
|
45 Participants
|
50 Participants
|
44 Participants
|
45 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePotential moderator. Val66Met polymorphism in the BDNF gene assessed using candidate genotyping. The BDNF gene locus is located on Chromosome 11. BDNF Met positive genotypes are heterozygous Val/Met or homozygous Met/Met. Results will be reported as presence of Met allele or absence of Met allele
Outcome measures
| Measure |
Usual Care
n=64 Participants
Participants in the usual care group do not receive any Mind- or Move-related intervention, and will receive their usual care from their cardiology provider.
|
Mind - BrainHQ Cognitive Training Intervention
n=64 Participants
The Mind intervention uses the evidence-based BrainHQ computerized cognitive training program. BrainHQ focuses on improving memory, attention, sensory function, and working memory, and has demonstrated efficacy in improving memory among healthy older adults and adults with heart failure. BrainHQ is tailored to the individual, and program difficulty automatically progresses based on performance. Training occurs during three 30-minute sessions per week, for a total of 36 hours. Participants will complete the BrainHQ program on an iPad tablet, which will be provided to them.
Mind: See arm description.
|
Move - Lifestyle Physical Activity Intervention
n=61 Participants
The Move intervention is a 24-week evidence-based program based on social cognitive theory. It was originally developed for midlife women and successfully maintained increased physical activity. It has since been tailored for older women with CVD to prevent or delay cognitive decline, and includes: (1) education on the importance of lifestyle physical activity for brain health, (2) increasing lifestyle physical activity while considering CVD, and (3) including a goal for increasing Fitbit "active" minutes (≥ 3 METs or moderate-intensity physical activity) to ensure participants are obtaining the beneficial aerobic fitness effects during periods of lifestyle physical activity. Core elements include a personal lifestyle physical activity goal and five group meetings.
Move: See arm description.
|
MindMoves - Cognitive Training and Lifestyle Physical Activity
n=64 Participants
Participants who are assigned to this condition will complete both the Move lifestyle physical activity program and the Mind BrainHQ cognitive training intervention simultaneously for 24 weeks (see Move and Mind descriptions). Participants will receive both a Fitbit and iPad tablet to complete the combined MindMoves intervention.
Mind: See arm description.
Move: See arm description.
|
|---|---|---|---|---|
|
Brain-derived Neurotrophic Factor (BDNF) Val66Met Polymorphism
Met allele present
|
9 Participants
|
17 Participants
|
9 Participants
|
18 Participants
|
|
Brain-derived Neurotrophic Factor (BDNF) Val66Met Polymorphism
Met allele absent
|
55 Participants
|
47 Participants
|
52 Participants
|
46 Participants
|
Adverse Events
Mind - BrainHQ Cognitive Training Intervention
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Move - Lifestyle Physical Activity Intervention
Serious events: 1 serious events
Other events: 6 other events
Deaths: 2 deaths
MindMoves - Cognitive Training and Lifestyle Physical Activity
Serious events: 0 serious events
Other events: 6 other events
Deaths: 1 deaths
Usual Care
Serious events: 2 serious events
Other events: 5 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Mind - BrainHQ Cognitive Training Intervention
n=64 participants at risk
The Mind intervention uses the evidence-based BrainHQ computerized cognitive training program. BrainHQ focuses on improving memory, attention, sensory function, and working memory, and has demonstrated efficacy in improving memory among healthy older adults and adults with heart failure. BrainHQ is tailored to the individual, and program difficulty automatically progresses based on performance. Training occurs during three 30-minute sessions per week, for a total of 36 hours. Participants will complete the BrainHQ program on an iPad tablet, which will be provided to them.
Mind: See arm description.
|
Move - Lifestyle Physical Activity Intervention
n=61 participants at risk
The Move intervention is a 24-week evidence-based program based on social cognitive theory. It was originally developed for midlife women and successfully maintained increased physical activity. It has since been tailored for older women with CVD to prevent or delay cognitive decline, and includes: (1) education on the importance of lifestyle physical activity for brain health, (2) increasing lifestyle physical activity while considering CVD, and (3) including a goal for increasing Fitbit "active" minutes (≥ 3 METs or moderate-intensity physical activity) to ensure participants are obtaining the beneficial aerobic fitness effects during periods of lifestyle physical activity. Core elements include a personal lifestyle physical activity goal and five group meetings.
Move: See arm description.
|
MindMoves - Cognitive Training and Lifestyle Physical Activity
n=64 participants at risk
Participants who are assigned to this condition will complete both the Move lifestyle physical activity program and the Mind BrainHQ cognitive training intervention simultaneously for 24 weeks (see Move and Mind descriptions). Participants will receive both a Fitbit and iPad tablet to complete the combined MindMoves intervention.
Mind: See arm description.
Move: See arm description.
|
Usual Care
n=64 participants at risk
Participants in the usual care group do not receive any Mind- or Move-related intervention, and will receive their usual care from their cardiology provider.
|
|---|---|---|---|---|
|
General disorders
Hospitalization
|
1.6%
1/64 • Number of events 1 • From baseline through follow-up data collection at 72 weeks
|
1.6%
1/61 • Number of events 1 • From baseline through follow-up data collection at 72 weeks
|
0.00%
0/64 • From baseline through follow-up data collection at 72 weeks
|
3.1%
2/64 • Number of events 2 • From baseline through follow-up data collection at 72 weeks
|
Other adverse events
| Measure |
Mind - BrainHQ Cognitive Training Intervention
n=64 participants at risk
The Mind intervention uses the evidence-based BrainHQ computerized cognitive training program. BrainHQ focuses on improving memory, attention, sensory function, and working memory, and has demonstrated efficacy in improving memory among healthy older adults and adults with heart failure. BrainHQ is tailored to the individual, and program difficulty automatically progresses based on performance. Training occurs during three 30-minute sessions per week, for a total of 36 hours. Participants will complete the BrainHQ program on an iPad tablet, which will be provided to them.
Mind: See arm description.
|
Move - Lifestyle Physical Activity Intervention
n=61 participants at risk
The Move intervention is a 24-week evidence-based program based on social cognitive theory. It was originally developed for midlife women and successfully maintained increased physical activity. It has since been tailored for older women with CVD to prevent or delay cognitive decline, and includes: (1) education on the importance of lifestyle physical activity for brain health, (2) increasing lifestyle physical activity while considering CVD, and (3) including a goal for increasing Fitbit "active" minutes (≥ 3 METs or moderate-intensity physical activity) to ensure participants are obtaining the beneficial aerobic fitness effects during periods of lifestyle physical activity. Core elements include a personal lifestyle physical activity goal and five group meetings.
Move: See arm description.
|
MindMoves - Cognitive Training and Lifestyle Physical Activity
n=64 participants at risk
Participants who are assigned to this condition will complete both the Move lifestyle physical activity program and the Mind BrainHQ cognitive training intervention simultaneously for 24 weeks (see Move and Mind descriptions). Participants will receive both a Fitbit and iPad tablet to complete the combined MindMoves intervention.
Mind: See arm description.
Move: See arm description.
|
Usual Care
n=64 participants at risk
Participants in the usual care group do not receive any Mind- or Move-related intervention, and will receive their usual care from their cardiology provider.
|
|---|---|---|---|---|
|
Psychiatric disorders
Elevated depressive symptoms
|
3.1%
2/64 • Number of events 2 • From baseline through follow-up data collection at 72 weeks
|
4.9%
3/61 • Number of events 3 • From baseline through follow-up data collection at 72 weeks
|
4.7%
3/64 • Number of events 3 • From baseline through follow-up data collection at 72 weeks
|
6.2%
4/64 • Number of events 4 • From baseline through follow-up data collection at 72 weeks
|
|
Cardiac disorders
Chest pain
|
1.6%
1/64 • Number of events 1 • From baseline through follow-up data collection at 72 weeks
|
0.00%
0/61 • From baseline through follow-up data collection at 72 weeks
|
0.00%
0/64 • From baseline through follow-up data collection at 72 weeks
|
0.00%
0/64 • From baseline through follow-up data collection at 72 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
1.6%
1/64 • Number of events 1 • From baseline through follow-up data collection at 72 weeks
|
4.9%
3/61 • Number of events 3 • From baseline through follow-up data collection at 72 weeks
|
4.7%
3/64 • Number of events 3 • From baseline through follow-up data collection at 72 weeks
|
1.6%
1/64 • Number of events 1 • From baseline through follow-up data collection at 72 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place