CompletedNot Applicable

Lifestyle Physical Activity and Cognitive Training Interventions

United States253 participantsStarted 2020-10-05

Plain-language summary

Older women with cardiovascular disease (CVD) are at greater risk for memory loss, an important public health issue due to the negative effects to quality of life and health care costs. This research will be the first to examine the independent and combined effects of a lifestyle physical activity intervention and cognitive training on memory performance and memory-related serum biomarkers in this vulnerable population. The investigators will incorporate a practical lifestyle approach that can be delivered in the home and community settings to prevent or delay memory loss in older women with CVD.

Who can participate

Age range

65 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * self-identified as women * ≥ 65 years old * read/speak English * patient in the Rush Heart Center for Women * history of CVD (e.g., coronary artery disease, hypertension) and receiving guideline-directed medical therapy when appropriate * no regular moderate-vigorous physical activity (≥ 30 minutes ≥ 3 days per week in the past month) * no cognitive training program in the past month * no disabilities preventing regular physical activity (Physical Activity Readiness Questionnaire, which includes cardiac and lung disease symptoms) * written approval from cardiology provider (Physical Activity Readiness Medical Examination); no self-reported significant hearing loss that interferes with normal conversation * access to a Bluetooth-capable phone or tablet Exclusion Criteria: * symptoms of unstable cardiac or pulmonary disease in the past month (Physical Activity Readiness Questionnaire) * blood pressure (systolic ≥ 160 or diastolic ≥ 100 mm Hg) * cognitive status score \< 19 on the blind version (for phone administration) of the Montreal Cognitive Assessment (MoCA) consistent with significant cognitive impairment * diagnosis of a neurological disease found in the electronic health record (e.g., Alzheimer's disease dementia, Parkinson's disease, vascular dementia) * transient ischemic attack or small-vessel stroke in the past three months * taking anti-psychotic medication * diabetes with an A1C ≥ 9.0 within the past six months * end-stage renal disease on…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in East Boston Memory Test Scores From Baseline to 24 Weeks, 48 Weeks, and 72 Weeks

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: Baseline, and 24 weeks, 48 weeks, and 72 weeks post-baseline

Trial details

NCT IDNCT04556305

SponsorRush University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01-12

Results submitted2025-01-28

View on ClinicalTrials.gov More Cognitive Decline trials