Goals-based exercise program for Black adults aged 45–65 to address cognitive decline
Exercise Adherence and Cognitive Decline: A Goal-setting and Exercise Intensity Intervention Collaboratively Developed With the Black Community
This program will try a goals-based exercise plan to help Black adults aged 45–65 exercise more and see if that slows cognitive decline.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 226 (estimated) |
| Ages | 45 Years to 65 Years |
| Sex | All |
| Sponsor | University of Colorado, Boulder Academic / other |
| Locations | 2 sites (Aurora, Colorado and 1 other locations) |
| Trial ID | NCT07127965 on ClinicalTrials.gov |
What this trial studies
This randomized interventional program was developed with a Black-led community organization (The Gyedi Project) and a Community Advisory Board to improve exercise adherence in middle-aged Black adults. Eligible participants who are not currently regularly active and who pass cognitive and safety screens will be randomized to a goal-setting and exercise-intensity intervention or a comparison condition and followed over roughly 14 months. Activities take place at recreation centers in the Denver metro area and at the University of Colorado Boulder and emphasize personalized goal difficulty and exercise intensity. The trial aims to increase physical activity and examine whether greater adherence is associated with slowed cognitive decline in a population underrepresented in prior exercise research.
Who should consider this trial
Good fit: Ideal candidates are Black or African American adults aged 45–65 who are not currently meeting moderate-to-vigorous activity thresholds, can walk three blocks and climb two flights of stairs without limiting symptoms, have minimal cognitive impairment on screening, and can remain in the Denver metro area for the study period.
Not a fit: People already regularly active, those with diagnosed dementia or serious psychiatric disorders or on antipsychotic medications, those with unsafe cardiovascular or mobility limitations, or those whose primary care provider raises safety concerns are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, the program could help midlife Black adults increase physical activity and potentially slow or reduce future cognitive decline and related health risks.
How similar studies have performed: Prior studies show goal-setting and exercise interventions can increase activity and sometimes slow cognitive decline, but this culturally tailored program for middle-aged Black adults is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * \<3 incorrect responses on the Pfeiffer Mental Status Questionnaire * Ages 45 to 65 * Consent to be randomized to conditions * Planning to remain in the Denver metro area for the next 14 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 * Inability to walk 3 blocks without chest pain, shortness of breath, or lightheadedness * Inability to climb 2 flights of stairs without chest pain, shortness of breath, or lightheadedness PCP Exclusion Criteria: * Answers "yes" to 1 or more of the 7 general questions of the PAR-Q+ and answers yes to any of the follow up questions. * Blood pressure at baseline is greater than 160/100 * Blood pressure at baseline is between 140/90 - 160/100 and the participant is currently taking blood pressure medication * Blood pressure \> 210/90 mmHg (for men) or \> 190/90 mmHg (for women) immediately after exercise
Where this trial is running
Aurora, Colorado and 1 other locations
- Recreation Centers in the Denver Metro Area — Aurora, Colorado, United States (Recruiting)
- University of Colorado at Boulder — Boulder, Colorado, United States (Recruiting)
Study contacts
- Study coordinator: Sarah Frances Crawford, B.A.
- Email: Sarah.Crawford-1@colorado.edu
- Phone: 423-771-1244
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.