Cognitive DeclineMindMovesNCT04556305
Lifestyle Physical Activity and Cognitive Training Interventions
A study testing Mind and Move in people with Cognitive Decline and Cardiovascular Diseases, run by Rush University Medical Center at 1 site in United States.
Trial summary
Older women with cardiovascular disease (CVD) are at greater risk for memory loss, an important public health issue due to the negative effects to quality of life and health care costs. Read more about this study
- Who is it for?
- Ages 65 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cognitive Decline, Cardiovascular Diseases, Cognitive Dysfunction
- What is being tested?
- Mind and Move
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 253 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2020to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- self-identified as women
- ≥ 65 years old
- read/speak English
- patient in the Rush Heart Center for Women
- history of CVD (e.g., coronary artery disease, hypertension) and receiving guideline-directed medical therapy when appropriate
- no regular moderate-vigorous physical activity (≥ 30 minutes ≥ 3 days per week in the past month)
Show all 10Show fewer
- no cognitive training program in the past month
- no disabilities preventing regular physical activity (Physical Activity Readiness Questionnaire, which includes cardiac and lung disease symptoms)
- written approval from cardiology provider (Physical Activity Readiness Medical Examination); no self-reported significant hearing loss that interferes with normal conversation
- access to a Bluetooth-capable phone or tablet
Who cannot join
- symptoms of unstable cardiac or pulmonary disease in the past month (Physical Activity Readiness Questionnaire)
- blood pressure (systolic ≥ 160 or diastolic ≥ 100 mm Hg)
- cognitive status score < 19 on the blind version (for phone administration) of the Montreal Cognitive Assessment (MoCA) consistent with significant cognitive impairment
- diagnosis of a neurological disease found in the electronic health record (e.g., Alzheimer's disease dementia, Parkinson's disease, vascular dementia)
- transient ischemic attack or small-vessel stroke in the past three months
- taking anti-psychotic medication
- diabetes with an A1C ≥ 9.0 within the past six months
- end-stage renal disease on dialysis (Stage 5)
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: Lifestyle Physical Activity and Cognitive Training Interventions: Preventing Memory Loss in Older Women With Cardiovascular Disease
Older women with cardiovascular disease (CVD) are at greater risk for memory loss, an important public health issue due to the negative effects to quality of life and health care costs. This research will be the first to examine the independent and combined effects of a lifestyle physical activity intervention and cognitive training on memory performance and memory-related serum biomarkers in this vulnerable population. The investigators will incorporate a practical lifestyle approach that can be delivered in the home and community settings to prevent or delay memory loss in older women with CVD.
Read the detailed description
Women experience disproportionately high rates of cognitive dysfunction, especially with increasing age, compared to men. Some research suggests that older women have a higher incidence of cognitive dysfunction with greater severity and more rapid decline.Furthermore, cardiovascular disease (CVD) increases the risk for cognitive dysfunction by 29-66% and affects 44 million women in the US.
One particularly distressing type of cognitive dysfunction due to CVD is loss of memory. Memory loss leads to reduced independence, lower quality of life, and higher healthcare costs. To prevent or delay loss of memory among older women with CVD, there is an urgent need to develop lifestyle interventions that can be scaled.
The long-term goal is to create and implement multi-modal lifestyle interventions (interventions that have multiple behavioral components) that will prevent or delay memory loss in older adults. The investigators initially focus on women with CVD due to their high risk. Physical activity interventions and cognitive training each prevent memory loss in healthy older adults.
Thus, the investigators will evaluate the efficacy of MindMoves, a 24-week multi-modal intervention, on memory performance and memory-related serum biomarkers. The investigators will examine the serum biomarkers of brain-derived neurotrophic factor (BDNF), vascular endothelial growth factor (VEGF), and (c) insulin-like growth factor 1 (IGF-1). Data collection will occur at baseline, 24 weeks, 48 weeks, and 72 weeks. MindMoves is a combination of two evidence-based interventions. Mind is the cognitive training program BrainHQ modified to a lifestyle-focused electronic tablet format. Mind improves memory performance in healthy older adults and those with heart failure. Move is a modified lifestyle physical activity intervention from the Women's Lifestyle Physical Activity Program, which the investigators piloted in women with CVD. The investigators recently tested the feasibility of MindMoves.
Using a 2x2 factorial design, the investigators will recruit 254 older women with CVD from cardiology clinics and randomize them to one of the following conditions: (1) Mind, (2) Move, (3) MindMoves, or (4) usual care control. This approach will allow us to evaluate main and interaction effects of Mind and/or Move on memory performance and memory-related biomarkers at 24, 48, and 72 weeks post-baseline.
Specific Aim 1 (primary): Determine the independent and combined efficacies of Mind and Move on memory performance assessed by neurocognitive tests among women ≥ 65 years of age with CVD.
Specific Aim 2 (secondary): Determine the independent and combined efficacies of Mind and Move on memory-related serum biomarkers (BDNF, VEGF, IGF-1) among women ≥ 65 years of age with CVD.
Specific Aim 3 (exploratory): Evaluate depressive symptoms and genetic factors as potential moderators of the association between changes in target behaviors (physical activity and cognitive activity) and health outcomes (memory performance and relevant serum biomarkers).
The investigators hypothesize that Mind and Move individually will each yield benefits to memory. However, it is hypothesized that the combined MindMoves will have a greater impact than the sum of the individual effects. Findings will provide key knowledge about the ability of practical multi-modal lifestyle interventions to target memory in older women with CVD.
- Conditions
- Cognitive Decline, Cardiovascular Diseases, Cognitive Dysfunction, Cognitive Impairment, Mild Cognitive Impairment
- Being tested
- Mind, Move
- Medical subject headings
- Cognitive Dysfunction, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MindBehavioural
See arm description.
MoveBehavioural
See arm description.
| Study group | Role | What they receive |
|---|---|---|
| Mind - BrainHQ cognitive training intervention | Experimental | 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. Receives: Behavioral: Mind |
| Move - lifestyle physical activity intervention | Experimental | 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. Receives: Behavioral: Move |
| MindMoves - cognitive training and lifestyle physical activity | Experimental | 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. Receives: Behavioral: Mind; Behavioral: Move |
| Usual Care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in East Boston Memory Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
The East Boston Memory Test is a performance-based neurocognitive test. Participants are read a brief story with 12 key elements. The participants are asked to recall elements immediately and again after three-minute delay. Each score (immediate and delayed recall) has a scale of 0-12, with a higher score indicating better cognitive performance. The total score is an average of the two subscores for immediate and delayed recall. The total score has a scale of 0-12, with a higher score indicating better cognitive performance.
Measured: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline
Change in Category Fluency Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
The Category Fluency Test is a performance-based neurocognitive test. Participants are asked to generate examples for two semantic categories (animals, fruits/vegetables) in separate 60-second trials. There are two separate scores (number of animals generated, number of fruits/vegetables generated). A minimum possible score is 0, with an infinite possible maximum score, with a higher score indicating better cognitive performance.
Measured: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline
Change in Digit Span Forwards and Backwards Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
The Digit Span Forwards and Backwards Test is a performance-based neurocognitive test. The examiner says a string of numbers (digit span). For Digit Span Forwards, participant recites digit span, gradually increasing in length. Test stops when participant fails to recite digit span of same length twice. For Digit Span Backwards, participant recites digit span backwards. There are two separate scores (Digit Span Forwards correct responses, Digit Span Backwards correct responses). Digit Span Forwards scores can range from 0-16, with higher scores indicating higher cognitive performance. Digit Span Backwards Scores range from 0-14, with higher scores indicating higher cognitive performance. A total score is a sum of the two scores, with a range of 0-30, with higher scores indicating higher cognitive performance.
Measured: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline
Change in Oral Trails A/B Tests Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
First, participants are asked to count from 1 to 25 (Part A). For Part B, the person is asked to verbally recite alternating numbers and letters until they reach 13 and the letter M. The possible scores is a combined time to completion of both Part A and B summed. Possible minimum score is "discontinued" due to failure to complete the test (a zero score). The maximum score is 300 seconds. A lower score (fewer seconds) indicates higher cognitive performance.
Measured: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline
Change in Digit Ordering Tests Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
Participants are asked to memorize and immediately recall in ascending order a series of numbers that gradually increase in length with each trial. Possible scores range from 0-16, with a higher score indicating higher cognitive performance.
Measured: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline
Secondary outcomes (8)
Change in Brain-derived Neurotrophic Factor (BDNF) Levels From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
We will obtain blood samples for BDNF. Pretreatment serum or plasma specimens will be prepared using standard techniques and archived at -80°C in aliquots with no specimen subjected to more than two freeze-thaw cycles. All assays performed in a blinded fashion and according to manufacturer's protocol using a 384-well modified method. Luminex FlexMAP 3D will be used with concentrations calculated based on 7-pt standard curves using a 5-parametric fit algorithm in xPONENT v4.0.3. Following recommendations, serum biomarkers will be obtained in the morning (8am-10am) following an 8-hour fast.
Measured: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline
Change in Vascular Endothelial Growth Factor A (VEGF) Levels From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
We will obtain blood samples for VEGF. Pretreatment serum or plasma specimens will be prepared using standard techniques and archived at -80°C in aliquots with no specimen subjected to more than two freeze-thaw cycles. All assays performed in a blinded fashion and according to manufacturer's protocol using a 384-well modified method. Luminex FlexMAP 3D will be used with concentrations calculated based on 7-pt standard curves using a 5-parametric fit algorithm in xPONENT v4.0.3. Following recommendations, serum biomarkers will be obtained in the morning (8am-10am) following an 8-hour fast.
Measured: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline
Change in Insulin-like Growth Factor 1 (IGF-1) From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
We will obtain blood samples for IGF-1. Pretreatment serum or plasma specimens will be prepared using standard techniques and archived at -80°C in aliquots with no specimen subjected to more than two freeze-thaw cycles. All assays performed in a blinded fashion and according to manufacturer's protocol using a 384-well modified method. Luminex FlexMAP 3D will be used with concentrations calculated based on 7-pt standard curves using a 5-parametric fit algorithm in xPONENT v4.0.3. Following recommendations, serum biomarkers will be obtained in the morning (8am-10am) following an 8-hour fast.
Measured: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline
Change in GT3XE-Plus Triaxial Accelerometer Minutes of Moderate Vigorous Physical Activity From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
The ActiGraph accelerometer is a motion sensor device that provides a valid assessment of physical activity in adult persons during treadmill Moveing/running and daily activity. The accelerometer records vertical accelerations as "counts." Participants are instructed to wear on the hip for seven consecutive days during waking hours only, except while swimming or bathing. To analyze the accelerometer data, we will use the following physical activity intensity cut points: light 100-1,565 counts/min (< 3 METS [metabolic equivalent of task]); moderate 1,566-6,139 (3.0-6.0 METS); vigorous ≥ 6,140 (≥ 6.1 METS). Findings are reported in mean daily minutes of moderate-vigorous physical activity
Measured: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline
Change in the Two-minute Step Test of Aerobic Fitness Score From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
This is a test of aerobic fitness that can be performed in a small space using minimal equipment. Participants step in place to a predesignated height for two minutes. This test is correlated with treadmill tests of aerobic fitness. The score is number of valid steps achieved reaching the predesignated height in two minutes.
Measured: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline
Change in Self-reported Physical Activity as Assessed by the Community Healthy Activities Model Program for Seniors (CHAMPS) Survey From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
The Community Health Activities Model Program for Seniors (CHAMPS) is a 30-item self-report questionnaire that assesses the leisure time, household, and transportation physical activity in past two weeks. Participants are asked how long they participate in 30 different activities and at what frequency. Each activity is assigned intensity. Scores include mean minutes per week of light and moderate-vigorous physical activity for both leisure time and household scales (minimum score of 0 minutes and maximum score of 24 hours, with higher scores indicating more time spent in physical activity).
Measured: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline
Change in Self-reported Cognitive Activity From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
Self-report cognitive activity is a self-report questionnaire of participation in nine activities that involve information processing with minimal physical or social demands. Participants rate on a five-point scale. The score is an average of nine items (minimum score of 9, maximum score of 54 with higher scores indicating higher self-reported levels of cognitive activity).
Measured: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline
Change in GT3XE-Plus Triaxial Accelerometer Minutes of Light Physical Activity From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
The ActiGraph accelerometer is a motion sensor device that provides a valid assessment of physical activity in adult persons during treadmill Moveing/running and daily activity. The accelerometer records vertical accelerations as "counts." Participants are instructed to wear on the hip for seven consecutive days during waking hours only, except while swimming or bathing. To analyze the accelerometer data, we will use the following physical activity intensity cut points: light 100-1,565 counts/min (< 3 METS [metabolic equivalent of task]); moderate 1,566-6,139 (3.0-6.0 METS); vigorous ≥ 6,140 (≥ 6.1 METS). Findings are reported in mean daily minutes of light physical activity
Measured: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start5 Oct 2020
- Primary completion12 Jan 2024
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cognitive DeclineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 253 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04556305
- Sponsor's protocol ID
- 18053104
- Acronym
- MindMoves
- Status last verified
- Nov 2025
- First submitted
- 4 Sep 2020
- Last updated
- 3 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Halloway S, Schoeny ME, Barnes LL, Arvanitakis Z, Pressler SJ, Braun LT, Volgman AS, Gamboa C, Wilbur J. A study protocol for MindMoves: A lifestyle physical activity and cognitive training intervention to prevent cognitive impairment in older women with cardiovascular disease. Contemp Clin Trials. 2021 Feb;101:106254. doi: 10.1016/j.cct.2020.106254. Epub 2020 Dec 29.
PubMed 33383230Halloway S, Volgman AS, Schoeny ME, Arvanitakis Z, Barnes LL, Pressler SJ, Vispute S, Braun LT, Tafini S, Williams M, Wilbur J. Overcoming Pandemic-Related Challenges in Recruitment and Screening: Strategies and Representation of Older Women With Cardiovascular Disease for a Multidomain Lifestyle Trial to Prevent Cognitive Decline. J Cardiovasc Nurs. 2024 Jul-Aug 01;39(4):359-370. doi: 10.1097/JCN.0000000000001000. Epub 2023 May 11.
PubMed 37167428Halloway S, Volgman AS, Barnes LL, Schoeny ME, Wilbur J, Pressler SJ, Laddu D, Phillips SA, Vispute S, Hall G, Shakya S, Goodyke M, Auger C, Cagin K, Borgia JA, Arvanitakis ZA. The MindMoves Trial: Cross-Sectional Analyses of Baseline Vascular Risk and Cognition in Older Women with Cardiovascular Disease. J Alzheimers Dis. 2024;100(4):1407-1416. doi: 10.3233/JAD-240100.
PubMed 39031356Rogers CA, Yeager C, Schoeny M, Wilbur J, Vispute S, Pressler SJ, Arvanitakis Z, Halloway S. Cognitive Training Intervention Adherence in Older Women with Cardiovascular Disease: A Secondary Analysis of the MindMoves Trial. J Cardiovasc Nurs. 2026 Mar-Apr 01;41(2):E63-E69. doi: 10.1097/JCN.0000000000001291. Epub 2025 Dec 22.
PubMed 41418039Shakya S, Sharp L, Tintle N, Fink AM, Hernandez R, Halloway S. Social Isolation and Daily Steps Are Associated With Fatigue in Older Women With Cardiovascular Disease: A Secondary Analysis of the MindMoves Trial. J Aging Phys Act. 2025 Aug 5;34(1):72-81. doi: 10.1123/japa.2024-0245. Print 2026 Feb 1.
PubMed 40763916Halloway S, Schoeny ME, Arvanitakis Z, Volgman AS, Pressler SJ, Vispute S, Wilhelm K, Borgia JA, Wilbur J, Barnes LL. A multidomain trial for cognition in women with cardiovascular disease. Alzheimers Dement. 2025 Jun;21(6):e70285. doi: 10.1002/alz.70285.
PubMed 40511694
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyle Physical Activity and Cognitive Training Interventions: Preventing Memory Loss in Older Women With Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT04556305
- Acronym / sponsor ID
- MindMoves / 18053104
- Conditions
- Cognitive Decline, Cardiovascular Diseases, Cognitive Dysfunction, Cognitive Impairment, Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 253 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- 12 Jan 2024 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 21 Sep 2020 (actual)
- Results
- Posted 30 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Older women with cardiovascular disease (CVD) are at greater risk for memory loss, an important public health issue due to the negative effects to quality of life and health care costs. This research will be the first to examine the independent and combined effects of a lifestyle physical activity intervention and cognitive training on memory performance and memory-related serum biomarkers in this vulnerable population. The investigators will incorporate a practical lifestyle approach that can be delivered in the home and community settings to prevent or delay memory loss in older women with CVD.
Detailed description
Women experience disproportionately high rates of cognitive dysfunction, especially with increasing age, compared to men. Some research suggests that older women have a higher incidence of cognitive dysfunction with greater severity and more rapid decline.Furthermore, cardiovascular disease (CVD) increases the risk for cognitive dysfunction by 29-66% and affects 44 million women in the US.
One particularly distressing type of cognitive dysfunction due to CVD is loss of memory. Memory loss leads to reduced independence, lower quality of life, and higher healthcare costs. To prevent or delay loss of memory among older women with CVD, there is an urgent need to develop lifestyle interventions that can be scaled.
The long-term goal is to create and implement multi-modal lifestyle interventions (interventions that have multiple behavioral components) that will prevent or delay memory loss in older adults. The investigators initially focus on women with CVD due to their high risk. Physical activity interventions and cognitive training each prevent memory loss in healthy older adults.
Thus, the investigators will evaluate the efficacy of MindMoves, a 24-week multi-modal intervention, on memory performance and memory-related serum biomarkers. The investigators will examine the serum biomarkers of brain-derived neurotrophic factor (BDNF), vascular endothelial growth factor (VEGF), and (c) insulin-like growth factor 1 (IGF-1). Data collection will occur at baseline, 24 weeks, 48 weeks, and 72 weeks. MindMoves is a combination of two evidence-based interventions. Mind is the cognitive training program BrainHQ modified to a lifestyle-focused electronic tablet format. Mind improves memory performance in healthy older adults and those with heart failure. Move is a modified lifestyle physical activity intervention from the Women's Lifestyle Physical Activity Program, which the investigators piloted in women with CVD. The investigators recently tested the feasibility of MindMoves.
Using a 2x2 factorial design, the investigators will recruit 254 older women with CVD from cardiology clinics and randomize them to one of the following conditions: (1) Mind, (2) Move, (3) MindMoves, or (4) usual care control. This approach will allow us to evaluate main and interaction effects of Mind and/or Move on memory performance and memory-related biomarkers at 24, 48, and 72 weeks post-baseline.
Specific Aim 1 (primary): Determine the independent and combined efficacies of Mind and Move on memory performance assessed by neurocognitive tests among women ≥ 65 years of age with CVD.
Specific Aim 2 (secondary): Determine the independent and combined efficacies of Mind and Move on memory-related serum biomarkers (BDNF, VEGF, IGF-1) among women ≥ 65 years of age with CVD.
Specific Aim 3 (exploratory): Evaluate depressive symptoms and genetic factors as potential moderators of the association between changes in target behaviors (physical activity and cognitive activity) and health outcomes (memory performance and relevant serum biomarkers).
The investigators hypothesize that Mind and Move individually will each yield benefits to memory. However, it is hypothesized that the combined MindMoves will have a greater impact than the sum of the individual effects. Findings will provide key knowledge about the ability of practical multi-modal lifestyle interventions to target memory in older women with CVD.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mind - BrainHQ cognitive training intervention | Experimental | Behavioral: MindThe 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. |
| Move - lifestyle physical activity intervention | Experimental | Behavioral: MoveThe 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. |
| MindMoves - cognitive training and lifestyle physical activity | Experimental | Behavioral: Mind, Behavioral: MoveParticipants 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. |
| Usual Care | No intervention | –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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- self-identified as women
- ≥ 65 years old
- read/speak English
- patient in the Rush Heart Center for Women
- history of CVD (e.g., coronary artery disease, hypertension) and receiving guideline-directed medical therapy when appropriate
Key exclusion criteria (8 listed)
- symptoms of unstable cardiac or pulmonary disease in the past month (Physical Activity Readiness Questionnaire)
- blood pressure (systolic ≥ 160 or diastolic ≥ 100 mm Hg)
- cognitive status score < 19 on the blind version (for phone administration) of the Montreal Cognitive Assessment (MoCA) consistent with significant cognitive impairment
- diagnosis of a neurological disease found in the electronic health record (e.g., Alzheimer's disease dementia, Parkinson's disease, vascular dementia)
- transient ischemic attack or small-vessel stroke in the past three months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MindSee arm description. | Behavioural | Mind - BrainHQ cognitive training intervention, MindMoves - cognitive training and lifestyle physical activity |
| MoveSee arm description. | Behavioural | MindMoves - cognitive training and lifestyle physical activity, Move - lifestyle physical activity intervention |
Primary outcome
Change in East Boston Memory Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
Time frame: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline
The East Boston Memory Test is a performance-based neurocognitive test. Participants are read a brief story with 12 key elements. The participants are asked to recall elements immediately and again after three-minute delay. Each score (immediate and delayed recall) has a scale of 0-12, with a higher score indicating better cognitive performance. The total score is an average of the two subscores for immediate and delayed recall. The total score has a scale of 0-12, with a higher score indicating better cognitive performance.
Change in Category Fluency Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
Time frame: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline
The Category Fluency Test is a performance-based neurocognitive test. Participants are asked to generate examples for two semantic categories (animals, fruits/vegetables) in separate 60-second trials. There are two separate scores (number of animals generated, number of fruits/vegetables generated). A minimum possible score is 0, with an infinite possible maximum score, with a higher score indicating better cognitive performance.
Change in Digit Span Forwards and Backwards Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
Time frame: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline
The Digit Span Forwards and Backwards Test is a performance-based neurocognitive test. The examiner says a string of numbers (digit span). For Digit Span Forwards, participant recites digit span, gradually increasing in length. Test stops when participant fails to recite digit span of same length twice. For Digit Span Backwards, participant recites digit span backwards. There are two separate scores (Digit Span Forwards correct responses, Digit Span Backwards correct responses). Digit Span Forwards scores can range from 0-16, with higher scores indicating higher cognitive performance. Digit Span Backwards Scores range from 0-14, with higher scores indicating higher cognitive performance. A total score is a sum of the two scores, with a range of 0-30, with higher scores indicating higher cognitive performance.
Change in Oral Trails A/B Tests Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
Time frame: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline
First, participants are asked to count from 1 to 25 (Part A). For Part B, the person is asked to verbally recite alternating numbers and letters until they reach 13 and the letter M. The possible scores is a combined time to completion of both Part A and B summed. Possible minimum score is "discontinued" due to failure to complete the test (a zero score). The maximum score is 300 seconds. A lower score (fewer seconds) indicates higher cognitive performance.
Change in Digit Ordering Tests Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
Time frame: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline
Participants are asked to memorize and immediately recall in ascending order a series of numbers that gradually increase in length with each trial. Possible scores range from 0-16, with a higher score indicating higher cognitive performance.
8 secondary outcomes
Change in Brain-derived Neurotrophic Factor (BDNF) Levels From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
Time frame: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline
Change in Vascular Endothelial Growth Factor A (VEGF) Levels From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
Time frame: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline
Change in Insulin-like Growth Factor 1 (IGF-1) From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
Time frame: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline
Change in GT3XE-Plus Triaxial Accelerometer Minutes of Moderate Vigorous Physical Activity From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
Time frame: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline
Change in the Two-minute Step Test of Aerobic Fitness Score From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
Time frame: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline
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
Time frame: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline
Change in Self-reported Cognitive Activity From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
Time frame: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline
Change in GT3XE-Plus Triaxial Accelerometer Minutes of Light Physical Activity From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks
Time frame: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 33383230Halloway S, Schoeny ME, Barnes LL, Arvanitakis Z, Pressler SJ, Braun LT, Volgman AS, Gamboa C, Wilbur J. A study protocol for MindMoves: A lifestyle physical activity and cognitive training intervention to prevent cognitive impairment in older women with cardiovascular disease. Contemp Clin Trials. 2021 Feb;101:106254. doi: 10.1016/j.cct.2020.106254. Epub 2020 Dec 29.
- Results publication: PubMed 37167428Halloway S, Volgman AS, Schoeny ME, Arvanitakis Z, Barnes LL, Pressler SJ, Vispute S, Braun LT, Tafini S, Williams M, Wilbur J. Overcoming Pandemic-Related Challenges in Recruitment and Screening: Strategies and Representation of Older Women With Cardiovascular Disease for a Multidomain Lifestyle Trial to Prevent Cognitive Decline. J Cardiovasc Nurs. 2024 Jul-Aug 01;39(4):359-370. doi: 10.1097/JCN.0000000000001000. Epub 2023 May 11.
- Results publication: PubMed 39031356Halloway S, Volgman AS, Barnes LL, Schoeny ME, Wilbur J, Pressler SJ, Laddu D, Phillips SA, Vispute S, Hall G, Shakya S, Goodyke M, Auger C, Cagin K, Borgia JA, Arvanitakis ZA. The MindMoves Trial: Cross-Sectional Analyses of Baseline Vascular Risk and Cognition in Older Women with Cardiovascular Disease. J Alzheimers Dis. 2024;100(4):1407-1416. doi: 10.3233/JAD-240100.
- Derived from this study: PubMed 41418039Rogers CA, Yeager C, Schoeny M, Wilbur J, Vispute S, Pressler SJ, Arvanitakis Z, Halloway S. Cognitive Training Intervention Adherence in Older Women with Cardiovascular Disease: A Secondary Analysis of the MindMoves Trial. J Cardiovasc Nurs. 2026 Mar-Apr 01;41(2):E63-E69. doi: 10.1097/JCN.0000000000001291. Epub 2025 Dec 22.
- Derived from this study: PubMed 40763916Shakya S, Sharp L, Tintle N, Fink AM, Hernandez R, Halloway S. Social Isolation and Daily Steps Are Associated With Fatigue in Older Women With Cardiovascular Disease: A Secondary Analysis of the MindMoves Trial. J Aging Phys Act. 2025 Aug 5;34(1):72-81. doi: 10.1123/japa.2024-0245. Print 2026 Feb 1.
- Derived from this study: PubMed 40511694Halloway S, Schoeny ME, Arvanitakis Z, Volgman AS, Pressler SJ, Vispute S, Wilhelm K, Borgia JA, Wilbur J, Barnes LL. A multidomain trial for cognition in women with cardiovascular disease. Alzheimers Dement. 2025 Jun;21(6):e70285. doi: 10.1002/alz.70285.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mind and Move in people with Cognitive Decline and Cardiovascular Diseases, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in East Boston Memory Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks (time frame: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04556305, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.