Exercise Adherence and Cognitive Decline: Phase 2 (MOVE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cognitive Decline
• Intervention / Treatment: Behavioral: Goal Setting and Exercise Intensity Intervention

• Study Type: Interventional
• Enrollment (Estimated): 226
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Soha Khadem, B.S.; Phone Number: 720-853-4676; Email: themovestudy@gmail.com

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80309
      • Recruiting
      • Recreation Centers in the Denver Metro Area
      • Contact: Soha Khadem, B.S.; Phone Number: 720-853-4676; Email: themovestudy@gmail.com
    • Boulder, Colorado, United States, 80309
      • Recruiting
      • Recreation Centers in the Boulder Area
      • Contact: Soha Khadem, B.S.; Phone Number: 720-853-4676; Email: themovestudy@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vigorous Intensity Exercise, Challenging Goal Difficulty; Participants are assigned to exercise at a vigorous intensity and create challenging goals.	Behavioral: Goal Setting and Exercise Intensity Intervention; Participants' goal-setting and exercise intensity are manipulated based on group assignment.
Experimental: Moderate Intensity Exercise, Basic Goal Difficulty; Participants are assigned to exercise at a moderate intensity and create basic goals	Behavioral: Goal Setting and Exercise Intensity Intervention; Participants' goal-setting and exercise intensity are manipulated based on group assignment.
Experimental: Moderate Intensity Exercise, Challenging Goal Difficulty; Participants are assigned to exercise at a moderate intensity and create challenging goals	Behavioral: Goal Setting and Exercise Intensity Intervention; Participants' goal-setting and exercise intensity are manipulated based on group assignment.
Experimental: Vigorous Intensity Exercise, Basic Goal Difficulty; Participants are assigned to exercise at a vigorous intensity and create basic goals	Behavioral: Goal Setting and Exercise Intensity Intervention; Participants' goal-setting and exercise intensity are manipulated based on group assignment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ventilatory Threshold	Talk Test. Graded treadmill test where intensity is increased at intervals to determine participant's ventilatory threshold.	Baseline
Blood Pressure	Blood pressure (systolic and diastolic) of all participants is collected before the intervention	Baseline, Visit 15 (6 Months after baseline), Visit 17 (12 months after baseline)
Activity Levels	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.	Baseline, Visit 15 (6 months after baseline), Visit 17 (12 months after baseline)
Sleep Levels	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.	Baseline, Visit 15 (6 months after baseline), Visit 17 (12 months after followup)
Exercise Intensity	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.	Baseline, Visit 15 (6 months after baseline), Visit 17 (12 months after baseline)
Exercise Behavior	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.	Baseline, Visit 17 (12 months after Baseline)
Exercise Behavior	modified Godin Shepard Leisure Time Physical Activity Questionnaire. Measures physical and leisure activity over a typical one week period	All study timepoints (Visits 1-17; approximately 14 months)
Theoretical Mediators of Exercise Behavior	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.	Baseline, Visit 12 (supervised exercise visit), Visits 14-17 (3, 6, 9, and 12 months after baseline)
Theoretical Mediators of Exercise Behavior	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.	Baseline, Visit 12 (supervised exercise visit), Visits 14-17 (3, 6, 9, and 12 months after baseline)
Theoretical Mediators of Exercise Behavior	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.	Baseline, Visit 12 (supervised exercise visit), Visits 14-17 (3, 6, 9, and 12 months after baseline)
Theoretical Mediators of Exercise Behavior	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.	Baseline, Visit 12 (supervised exercise visit), Visits 14-17 (3, 6, 9, and 12 months after baseline)
Theoretical Mediators of Exercise Behavior	Exercise alignment with Black identity. Assessment of the extent to which 7 common exercises are aligned with Black identity	Baseline, Visit 12 (supervised exercise visit), Visits 14-17 (3, 6, 9, and 12 months after baseline)
Heart Rate Variability	Heart Rate Variability is measured using chest strap monitor.	Baseline, Visit 17 (12 months after Baseline)
Heart Rate	Heart Rate is measured using chest strap monitor.	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)
Perceived Exertion	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).	Baseline, Visits 2-13 (Supervised Exercise Training, 1 hour 3x/week for 4 weeks)
Pain Levels	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).	Visits 2, 6, 12 (Supervised Exercise Training)
Affective Valence	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).	Visit 12, Visits 14-16 (3, 6, and 9 months after baseline)
Affective Arousal	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).	Visits 2, 6, 12 (Supervised Exercise Training)
Enjoyment	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).	Visits 2, 6, 12 (Supervised Exercise Training)
Exercise Check-In	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	Visits 14-17 (3, 6, 9, and 12 months after baseline)
Exercise Benefits and Barriers	A 10 item scale assessing perceived benefits of and barriers to exercise	Baseline, Visit 12 (supervised exercise visit), Visits 14-17 (3, 6, 9, and 12 months after baseline)
Anthropometrics	Height will be measured in centimeters	Baseline, Visit 17 (12-month follow-up)
Diet	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.	Baseline, Visit 17 (12-month follow-up)
Demographics	Survey includes gender, sexual orientation, age, detailed race/ethnicity, and SES	Baseline
Objective Physical Activity	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).	Baseline, Visit 15 (6 months after baseline), Visit 17 (12 months after baseline)
Biomarkers of Cognitive Aging	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.	Baseline and Visit 17 (12 months after baseline)
Anthropometrics	Weight will be measured in pounds	Baseline, Visit 17 (12-month follow-up)

Collaborators and Investigators

• Sponsor: University of Colorado, Boulder

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2025
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028

Study Registration Dates

• First Submitted: August 7, 2025
• First Submitted That Met QC Criteria: August 13, 2025
• First Posted (Actual): August 17, 2025

Study Record Updates

• Last Update Posted (Actual): June 11, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Cognitive Decline; Exercise Intensity; Goals; Goal Difficulty
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 25-0479

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No