Exercise Adherence and Cognitive Decline: Phase 2

Not Applicable

Not yet recruiting

• Conditions: Cognitive Decline

• Registration Number: NCT07127965
• Lead Sponsor: University of Colorado, Boulder

Brief Summary

The purpose of this study is to conduct a test of a goals-based program to help people exercise more. This program was 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-07
• Study First Submitted QC: 2025-08-13
• Last Update Submitted: 2025-08-13
• Study First Posted: 2025-08-17
• Last Update Posted: 2025-08-17
• Study Start: 2025-11-15
• Primary Completion: 2028-08-31
• Study Completion: 2028-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 226

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Blood Pressure	Baseline, Visit 15 (6 Months after baseline), Visit 17 (12 months after baseline)	Blood pressure (systolic and diastolic) of all participants is collected before the intervention
Activity Levels	Baseline, Visit 15 (6 months after baseline), Visit 17 (12 months after baseline)	Exercise Intensity (PAR). Answers are direct (ex. how many hours active) and not scaled. Information is requested for the week and the past 3 months.
Sleep Levels	Baseline, Visit 15 (6 months after baseline), Visit 17 (12 months after followup)	Exercise Intensity (PAR). Answers are direct (ex. how many hours did you sleep) and are not scaled. Information is requested for the past 7 days.
Exercise Intensity	Baseline, Visit 15 (6 months after baseline), Visit 17 (12 months after baseline)	Exercise Intensity (PAR). Answers are direct (ex. how many hours did you sleep) and are not scaled. Information is requested for the past 7 days.
Ventilatory Threshold	Baseline	Talk Test. Graded treadmill test where intensity is increased at intervals to determine participant's ventilatory threshold.
Pain Levels	Visits 2, 6, 12 (Supervised Exercise Training)	A single item measure from Borg (1998) was used to assess participants' pain levels during the exercise bout. Participants were asked to indicate how much pain they felt \[at that moment/during the past ten minutes\] on an 11-point scale ranging from 0 (nothing at all) to 10 (excruciating).
Affective Arousal	Visits 2, 6, 12 (Supervised Exercise Training)	The Felt Arousal Scale, a single-item measure from Svebak and Murgatroyd (1985), was used to assess participants' affective arousal during the exercise bout. Participants were asked to indicate how "worked-up" they felt \[at that moment/during the past ten minutes\] on a 6-point scale ranging from 1 (low arousal) to 6 (high arousal).
Enjoyment	Visits 2, 6, 12 (Supervised Exercise Training)	A single item measure from Gillman and Bryan (2015) was used to assess participants' enjoyment levels during the exercise bout. Participants were asked to indicate how enjoyable exercise was \[at that moment/during the past ten minutes\] on a 5-point scale ranging from 1 (no enjoyment at all) to 5 (a great deal of enjoyment).
Demographics	Baseline	Survey includes gender, sexual orientation, age, detailed race/ethnicity, and SES
Objective Physical Activity	Baseline, Visit 15 (6 months after baseline), Visit 17 (12 months after baseline)	Objective physical activity will be measured through ActiGraph. Participants will be given the ActiGraph at baseline and will be asked to wear the device for one week. Participants will then be asked to wear the watch continuously for the week before visit 15 (6-month follow-up) and visit 17 (12-month follow-up).
Exercise Behavior	All study timepoints (Visits 1-17; approximately 14 months)	modified Godin Shepard Leisure Time Physical Activity Questionnaire. Measures physical and leisure activity over a typical one week period
Theoretical Mediators of Exercise Behavior	Baseline, Visit 12 (supervised exercise visit), Visits 14-17 (3, 6, 9, and 12 months after baseline)	Exercise alignment with Black identity. Assessment of the extent to which 7 common exercises are aligned with Black identity
Heart Rate	Baseline, Visits 2-13 (Supervised Exercise Training, 1 hour 3x/week for 4 weeks), Visit 15 (6-month follow-up), Visit 17 (12-month follow-up)	Heart Rate is measured using chest strap monitor.
Perceived Exertion	Baseline, Visits 2-13 (Supervised Exercise Training, 1 hour 3x/week for 4 weeks)	A single-item measure from Borg (1973) was used to assess participants' rate of perceived exertion (RPE) during the exercise bout. Participants were asked to rate the average intensity of exercise \[at that moment/during the past ten minutes\] on a 25-point scale ranging from 6 (no exertion at all) to 20 (maximal exertion).
Diet	Baseline, Visit 17 (12-month follow-up)	NCI's Eating at America's Table Study (EATS) Fruit \& Vegetable All-Day Screener. A short dietary assessment instrument for measuring fruit and vegetable intake over the past month.
Biomarkers of Cognitive Aging	Baseline and Visit 17 (12 months after baseline)	Biomarkers of cognitive again will be analyzed by blood samples. Blood samples will be collected at baseline and Visit 17 (12-month follow-up) and stored. At the end of the study, samples will be sent for analysis of biomarkers involved in cognitive aging, including p-tau181, NfL, Ab40, Ab42, GFAP, and IGF-1.
Heart Rate Variability	Baseline, Visit 17 (12 months after Baseline)	Heart Rate Variability is measured using chest strap monitor.
Affective Valence	Visit 12, Visits 14-16 (3, 6, and 9 months after baseline)	The Feeling Scale, a single-item measure from Hardy and Rejeski (1989), was used to assess participants' affective valence during the exercise bout. Participants were asked to indicate how they felt \[at that moment/during the past ten minutes\] on an 11-point scale ranging from -5 (very bad) to +5 (very good).
Exercise Check-In	Visits 14-17 (3, 6, 9, and 12 months after baseline)	Three short questions assessing if the participant planned to engage in exercise and how many minutes of moderate (0-120) and vigorous (0-60) exercise they engaged in
Exercise Benefits and Barriers	Baseline, Visit 12 (supervised exercise visit), Visits 14-17 (3, 6, 9, and 12 months after baseline)	A 10 item scale assessing perceived benefits of and barriers to exercise
Anthropometrics	Baseline, Visit 17 (12-month follow-up)	Weight will be measured in pounds

Trial Locations

Locations (2)

Recreation Centers in the Denver Metro Area; 🇺🇸 Aurora, Colorado, United States

University of Colorado at Boulder; 🇺🇸 Boulder, Colorado, United States