Exercise Adherence and Cognitive Decline (MOVE)

Exercise Adherence and Cognitive Decline: Engaging With the Black Community to Develop and Test a Goal-Setting and Exercise Intensity Intervention

The purpose of this study is to conduct a small-scale test of a goals-based program to help people to exercise more and learn what people like or don't like about the procedures. This program is being 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, and now the investigators are conducting a trial of its feasibility and acceptability.

Study Overview

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

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marin McCallen, BA; Phone Number: (720)853-4676; Email: marin.mccallen@colorado.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80011
      • Recruiting
      • Aurora Center for Active Adults
      • Contact: Marin McCallen, BA; Phone Number: 720-853-4676; Email: marin.mccallen@colorado.edu
    • Boulder, Colorado, United States, 80309
      • Recruiting
      • University of Colorado at Boulder
      • Principal Investigator: Angela Bryan, PhD
      • Contact: Marin McCallen, BA; Phone Number: (720)853-4676; Email: marin.mccallen@colorado.edu
      • Sub-Investigator: Kweku Hazel, MD
      • Sub-Investigator: Cynthia Hazel, DrPH
    • Denver, Colorado, United States, 80207
      • Recruiting
      • Hiawatha Davis Jr. Recreation Center
      • Contact: Marin McCallen, BA; Phone Number: 720-853-4676; Email: marin.mccallen@colorado.edu

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 45-65.
• Consent to be randomized to condition.
• Planning to remain in the Denver metro area for the next two 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
• Answers "yes" to 1 or more of the 7 questions of the PAR-Q+
• Blood pressure at baseline or before exercise is greater than 140/90
• Blood pressure >210/90 mmHg (for men) or >190/90 mmHg (for women) immediately after exercise
• Inability to walk 3 blocks without chest pain, shortness of breath, or light headedness.
• Inability to climb 2 flights of stairs without chest pain, shortness of breath, or light headedness.

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: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Pressure	Blood pressure of all participants is collected before intervention	Baseline, Visit 14 (~2 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 14 (~2 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 14 (~2 months after baseline)
Physical Activity Recall	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 14 (~2 months after baseline)
Identity	Multidimensional Black Identity Scale to collect information on identity. Questions are about personal identity relating to the Black community on a scale of 1-7, 1 being strongly disagree and 7 being strongly agree. Higher scores indicate a stronger agreement with that dimension of Black identity. Scores are summed as subscales and averaged to obtain an average score.	Baseline
Exercise Behavior	CHAMPS. The survey collects quantitative data looking at the approximate total hours per week spent doing various activities, both physical and social.	Baseline, Visit 14 (~2 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 14 (~2 months after baseline)
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 (~1 month after baseline), Visit 14 (~2 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 (~1 month after baseline), Visit 14 (~2 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 (~1 month after baseline), Visit 14 (~2 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 (~1 month after baseline), Visit 14 (~2 months after baseline)
Heart Rate Variability	Heart Rate Variability is measured using chest strap monitor.	Baseline, Visit 14 (~2 months after baseline)
Heart Rate	HR is measured using chest strap monitor.	Baseline, Visits 1-14 (all visits)
Physical Performance	Short Physical Performance Battery. Physical performance measured with repeated chair stands, three balance tests (side-by-side, semi-tandem, tandem), timed walking.	Baseline, Visit 14 (~2 months after baseline)
Ventilatory Threshold	Talk Test. Graded treadmill test where intensity is increased at intervals to determine participant's ventilatory threshold.	Baseline
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).	Visit 2-13 (~2 visits/week)
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).	Visit 2-13 (~2 visits/week)
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 2-13 (~2 visits/week)
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).	Visit 2-13 (~2 visits/week)
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).	Visit 2-13 (~2 visits/week)
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	Daily between visit 13 and 14 (~1 month)
Study Feedback	An investigator led interview to pilot study participants' experience of the intervention and suggestions for improvement	Visit 14 (~2 months after baseline)
Exercise Benefits and Barriers	A 10 item scale assessing perceived benefits of and barriers to exercise	Baseline, Visit 12 (~1 month after baseline), Visit 14 (~2 months after baseline)
Anthropometrics	Height, weight, waist circumference, and hip circumference will be measured	Baseline
Exercise Aligned with Black Identity	Assessment of the extent to which 7 common exercises are aligned with Black identity	Baseline
Mental Status	Pfeiffer Mental Status. Assessment of cognitive deficits at baseline.	Baseline
Diet	Nutrition Data System for Research (NDSR) 24-Hour Dietary Recall. Interviewer administered recall developed by the University of Minnesota Nutrition Coordinating Center (NCC).	Baseline
Diet	NCI's Eating at America's Table Study (EATS) Fruit & Vegetable All-Day Screener174 NCI's Eating at America's Table Study (EATS) Fruit & Vegetable All-Day Screener174 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
Physical Activity	Godin Survey. This survey measures time spent in moderate, strenuous or light activity and has been modified to include time spent sitting over a typical 7 day period. Scores are summed and a range is used to quantify how active/sedentary a participant is.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographics	Survey includes sex assigned at birth, gender identity, sexual orientation, age, detailed race/ethnicity, and SES	Baseline

Collaborators and Investigators

• Sponsor: University of Colorado, Boulder
• Collaborators: National Institute on Aging (NIA)

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: December 3, 2024
• First Submitted That Met QC Criteria: January 6, 2025
• First Posted (Actual): January 10, 2025

Study Record Updates

• Last Update Posted (Actual): August 12, 2025
• Last Update Submitted That Met QC Criteria: August 7, 2025
• Last Verified: August 1, 2025

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: 23-01-0205; 1R61AG078088-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No