CompletedNot Applicable

Exercise Adherence and Cognitive Decline

United States21 participantsStarted 2024-10-01

Plain-language summary

The purpose of this study is to conduct a small-scale test of a goals-based program to help people to exercise more and learn what people like or don't like about the procedures. This program is being designed for individuals aged 45-65 from the Black community. Low levels of physical activity are related to health problems such as heart disease, diabetes, and cognitive decline. People of color are more negatively impacted by these conditions and have also historically been underrepresented by research seeking to increase physical activity. The investigators have developed this goals-based exercise promotion program with the help of a Black-led community-based organization (The Gyedi Project) and a Community Advisory Board made up of stakeholders in the Black community, and now the investigators are conducting a trial of its feasibility and acceptability.

Who can participate

Age range

45 Years – 65 Years

Sex

ALL

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: * \<3 incorrect responses on the Pfeiffer Mental Status Questionnaire * Ages 45-65. * Consent to be randomized to condition. * Planning to remain in the Denver metro area for the next two months * Identify as Black or African American Exclusion Criteria: * Currently physically active (i.e., \>90 min/week of moderate PA or \>40 min/week of vigorous PA consistently for the past 6 months). * On antipsychotic medications or currently under treatment for any serious psychiatric disorder, including Alzheimer's or dementia * Answers "yes" to 1 or more of the 7 questions of the PAR-Q+ * Blood pressure at baseline or before exercise is greater than 140/90 * Blood pressure \>210/90 mmHg (for men) or \>190/90 mmHg (for women) immediately after exercise * Inability to walk 3 blocks without chest pain, shortness of breath, or light headedness. * Inability to climb 2 flights of stairs without chest pain, shortness of breath, or light headedness.

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

Blood Pressure

Timeframe: Baseline, Visit 14 (~2 months after baseline)

Activity Levels

Timeframe: Baseline, Visit 14 (~2 months after baseline)

Sleep levels

Timeframe: Baseline, Visit 14 (~2 months after baseline)

Physical Activity Recall

Timeframe: Baseline, Visit 14 (~2 months after baseline)

Identity

Timeframe: Baseline

Exercise Behavior

Timeframe: Baseline, Visit 14 (~2 months after baseline)

Exercise Behavior

Timeframe: Baseline, Visit 14 (~2 months after baseline)

Theoretical Mediators of Exercise Behavior

Trial details

NCT IDNCT06769022

SponsorUniversity of Colorado, Boulder

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-07

View on ClinicalTrials.gov More Cognitive Decline trials

Plain-language summary

Who can participate

Age range

45 Years – 65 Years

Sex

ALL

See this in plain English?

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

What they're measuring

Blood Pressure

Timeframe: Baseline, Visit 14 (~2 months after baseline)

Activity Levels

Timeframe: Baseline, Visit 14 (~2 months after baseline)

Sleep levels

Timeframe: Baseline, Visit 14 (~2 months after baseline)

Physical Activity Recall

Timeframe: Baseline, Visit 14 (~2 months after baseline)

Identity

Timeframe: Baseline

Exercise Behavior

Timeframe: Baseline, Visit 14 (~2 months after baseline)

Exercise Behavior

Timeframe: Baseline, Visit 14 (~2 months after baseline)

Theoretical Mediators of Exercise Behavior