Exercise Adherence and Cognitive Decline: Phase 2 (MOVE)

June 9, 2026 updated by: Angela Bryan, University of Colorado, Boulder

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
226

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80309
        • Recruiting
        • Recreation Centers in the Denver Metro Area
        • Contact:
      • Boulder, Colorado, United States, 80309
        • Recruiting
        • Recreation Centers in the Boulder Area
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Ventilatory Threshold
Time Frame: Baseline
Talk Test. Graded treadmill test where intensity is increased at intervals to determine participant's ventilatory threshold.
Baseline
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
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)
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
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.
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 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
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.
Baseline, Visit 17 (12 months after Baseline)
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
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)
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
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.
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)
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
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.
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)
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
Time Frame: Baseline, Visit 17 (12 months after Baseline)
Heart Rate Variability is measured using chest strap monitor.
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)
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
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).
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)
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
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).
Visit 12, Visits 14-16 (3, 6, and 9 months after baseline)
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).
Visits 2, 6, 12 (Supervised Exercise Training)
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).
Visits 2, 6, 12 (Supervised Exercise Training)
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
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)
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
Time Frame: Baseline, Visit 17 (12-month follow-up)
Height will be measured in centimeters
Baseline, Visit 17 (12-month follow-up)
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.
Baseline, Visit 17 (12-month follow-up)
Demographics
Time Frame: Baseline
Survey includes gender, sexual orientation, age, detailed race/ethnicity, and SES
Baseline
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).
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)
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
Time Frame: Baseline, Visit 17 (12-month follow-up)
Weight will be measured in pounds
Baseline, Visit 17 (12-month follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Colorado, Boulder

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 5, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 7, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 17, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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