Recruiting

Exercise Promotion

Sponsor:

University of Colorado, Boulder

Code:

NCT07127965

Conditions

Cognitive Decline

Eligibility Criteria

Sex: All

Age: 45 - 65

Healthy Volunteers: Accepted

Interventions

Goal Setting and Exercise Intensity Intervention

Study Details

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.

Conditions

Cognitive Decline

Study ID

NCT07127965

Start date

Nov 5, 2025

Status verified date

Jun, 2026

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Aug 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 65

Healthy Volunteers: Accepted

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

Enrollment

226 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Moderate Intensity Exercise, Basic Goal Difficulty

Participants are assigned to exercise at a moderate intensity and create basic goals

experimental: Moderate Intensity Exercise, Challenging Goal Difficulty

Participants are assigned to exercise at a moderate intensity and create challenging goals

experimental: Vigorous Intensity Exercise, Basic Goal Difficulty

Participants are assigned to exercise at a vigorous intensity and create basic goals

experimental: Vigorous Intensity Exercise, Challenging Goal Difficulty

Participants are assigned to exercise at a vigorous intensity and create challenging goals.

Interventions

Goal Setting and Exercise Intensity Intervention

Participants' goal-setting and exercise intensity are manipulated based on group assignment.

Primary outcome measure

  • Blood Pressure [ Time Frame: Baseline, Visit 15 (6 Months after baseline), Visit 17 (12 months after baseline) ]
  • Activity Levels [ Time Frame: Baseline, Visit 15 (6 months after baseline), Visit 17 (12 months after baseline) ]
  • Sleep Levels [ Time Frame: Baseline, Visit 15 (6 months after baseline), Visit 17 (12 months after followup) ]
  • Exercise Intensity [ Time Frame: Baseline, Visit 15 (6 months after baseline), Visit 17 (12 months after baseline) ]
  • Exercise Behavior [ Time Frame: Baseline, Visit 17 (12 months after Baseline) ]
  • Exercise Behavior [ Time Frame: All study timepoints (Visits 1-17; approximately 14 months) ]
  • Theoretical Mediators of Exercise Behavior [ Time Frame: Baseline, Visit 12 (supervised exercise visit), Visits 14-17 (3, 6, 9, and 12 months after baseline) ]
  • Theoretical Mediators of Exercise Behavior [ Time Frame: Baseline, Visit 12 (supervised exercise visit), Visits 14-17 (3, 6, 9, and 12 months after baseline) ]
  • Theoretical Mediators of Exercise Behavior [ Time Frame: Baseline, Visit 12 (supervised exercise visit), Visits 14-17 (3, 6, 9, and 12 months after baseline) ]
  • Theoretical Mediators of Exercise Behavior [ Time Frame: Baseline, Visit 12 (supervised exercise visit), Visits 14-17 (3, 6, 9, and 12 months after baseline) ]
  • Theoretical Mediators of Exercise Behavior [ Time Frame: Baseline, Visit 12 (supervised exercise visit), Visits 14-17 (3, 6, 9, and 12 months after baseline) ]
  • Heart Rate Variability [ Time Frame: Baseline, Visit 17 (12 months after Baseline) ]
  • Heart Rate [ Time Frame: 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) ]
  • Ventilatory Threshold [ Time Frame: Baseline ]
  • Perceived Exertion [ Time Frame: Baseline, Visits 2-13 (Supervised Exercise Training, 1 hour 3x/week for 4 weeks) ]
  • Pain Levels [ Time Frame: Visits 2, 6, 12 (Supervised Exercise Training) ]
  • Affective Valence [ Time Frame: Visit 12, Visits 14-16 (3, 6, and 9 months after baseline) ]
  • Affective Arousal [ Time Frame: Visits 2, 6, 12 (Supervised Exercise Training) ]
  • Enjoyment [ Time Frame: Visits 2, 6, 12 (Supervised Exercise Training) ]
  • Exercise Check-In [ Time Frame: Visits 14-17 (3, 6, 9, and 12 months after baseline) ]
  • Exercise Benefits and Barriers [ Time Frame: Baseline, Visit 12 (supervised exercise visit), Visits 14-17 (3, 6, 9, and 12 months after baseline) ]
  • Anthropometrics [ Time Frame: Baseline, Visit 17 (12-month follow-up) ]
  • Diet [ Time Frame: Baseline, Visit 17 (12-month follow-up) ]
  • Demographics [ Time Frame: Baseline ]
  • Objective Physical Activity [ Time Frame: Baseline, Visit 15 (6 months after baseline), Visit 17 (12 months after baseline) ]
  • Biomarkers of Cognitive Aging [ Time Frame: Baseline and Visit 17 (12 months after baseline) ]
  • Anthropometrics [ Time Frame: Baseline, Visit 17 (12-month follow-up) ]

Central Contacts and Locations

Central contacts

Soha Khadem, B.S.

720-853-4676themovestudy@gmail.com

Locations

Recreation Centers in the Denver Metro Area

Recruiting

Aurora, Colorado, United States, 80309

Contacts

Soha Khadem, B.S.

720-853-4676themovestudy@gmail.com

Recreation Centers in the Boulder Area

Recruiting

Boulder, Colorado, United States, 80309

Contacts

Soha Khadem, B.S.

720-853-4676themovestudy@gmail.com

More Information

Sponsor

University of Colorado, Boulder

Last update posted

Jun 11, 2026

Last verified

Jun, 2026

Keywords

  • Goals
  • Goal Difficulty
  • Exercise Intensity
  • Cognitive Decline

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Boulder on 2026-06-11.