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NCT Number: NCT07127965

Exercise Adherence and Cognitive Decline: Phase 2

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.

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Key information

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Goal Setting and Exercise Intensity Intervention

Behavioral

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

Primary outcomes

  1. Blood Pressure

    Time frame: 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

  2. Activity Levels

    Time frame: 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.

  3. Sleep Levels

    Time frame: 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.

  4. Exercise Intensity

    Time frame: 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.

  5. Exercise Behavior

    Time frame: Baseline, Visit 17 (12 months after Baseline)

    L-Cat. Single question that asks about frequency/rigor of physical activity, with six potential answers ranging from no physical activity to daily physical activity.

  6. Exercise Behavior

    Time frame: 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

  7. Theoretical Mediators of Exercise Behavior

    Time frame: Baseline, Visit 12 (supervised exercise visit), Visits 14-17 (3, 6, 9, and 12 months after baseline)

    Intrinsic Motivation Inventory. Questions relate to how participants think or feel about physical activity, with answers ranging from 1 (strongly disagree) to 7 (strongly agree). Broader scores are broken up into subscales; final subscale scores are summed and averaged. Higher scores indicate higher agreement with that subscale.

  8. Theoretical Mediators of Exercise Behavior

    Time frame: Baseline, Visit 12 (supervised exercise visit), Visits 14-17 (3, 6, 9, and 12 months after baseline)

    Self-Efficacy. 9 questions about confidence in exercise on scale of 1 (disagree strongly) to 7 (agree strongly). Higher scores indicate higher perceived confidence in doing that activity. Total scores are summed.

  9. Theoretical Mediators of Exercise Behavior

    Time frame: Baseline, Visit 12 (supervised exercise visit), Visits 14-17 (3, 6, 9, and 12 months after baseline)

    Exercise Intention Survey. Scored on a Likert scale from 1 (strongly disagree) to 7 (strongly agree) to indicate level of agreement to statements related to intention to exercise. Scores are summed to produce a total score. Higher scores indicate stronger intention to exercise, lower scores indicate weaker intention.

  10. Theoretical Mediators of Exercise Behavior

    Time frame: Baseline, Visit 12 (supervised exercise visit), Visits 14-17 (3, 6, 9, and 12 months after baseline)

    Exercise Identity Score. Scored on a Likert scale from 1 (strongly disagree) to 7 (strongly agree) to indicate level of agreement to statements related to attitudes towards exercise. Scores are summed and averaged to provide an overall score. Higher scores indicate a positive attitude towards exercise, lower scores less favorable attitude.

  11. Theoretical Mediators of Exercise Behavior

    Time frame: 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

  12. Heart Rate Variability

    Time frame: Baseline, Visit 17 (12 months after Baseline)

    Heart Rate Variability is measured using chest strap monitor.

  13. 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)

    Heart Rate is measured using chest strap monitor.

  14. Ventilatory Threshold

    Time frame: Baseline

    Talk Test. Graded treadmill test where intensity is increased at intervals to determine participant's ventilatory threshold.

  15. Perceived Exertion

    Time frame: 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).

  16. Pain Levels

    Time frame: 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).

  17. Affective Valence

    Time frame: 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).

  18. Affective Arousal

    Time frame: 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).

  19. Enjoyment

    Time frame: 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).

  20. Exercise Check-In

    Time frame: 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

  21. Exercise Benefits and Barriers

    Time frame: 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

  22. Anthropometrics

    Time frame: Baseline, Visit 17 (12-month follow-up)

    Height will be measured in centimeters

  23. Diet

    Time frame: 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.

  24. Demographics

    Time frame: Baseline

    Survey includes gender, sexual orientation, age, detailed race/ethnicity, and SES

  25. Objective Physical Activity

    Time frame: 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).

  26. Biomarkers of Cognitive Aging

    Time frame: 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.

  27. Anthropometrics

    Time frame: Baseline, Visit 17 (12-month follow-up)

    Weight will be measured in pounds

Study contacts

Contact information is provided by the study sponsor or research team.

Soha Khadem, B.S.

CONTACT

[email protected]

720-853-4676

Sponsors and collaborators

Lead sponsor

University of Colorado, Boulder

Other

Registry information

Official study title

Exercise Adherence and Cognitive Decline: A Goal-setting and Exercise Intensity Intervention Collaboratively Developed With the Black Community

Acronym: MOVE

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Aug 17, 2025
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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