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Cognitive DeclineMOVENCT07127965

Exercise Adherence and Cognitive Decline: Phase 2

A study testing Goal Setting and Exercise Intensity Intervention in people with Cognitive Decline, run by University of Colorado, Boulder at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 45 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Cognitive Decline
What is being tested?
Goal Setting and Exercise Intensity Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
226 participants
Where
2 sitesUnited States
Study dates
5 Nov 2025to 31 Aug 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • <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

Who cannot join

  • 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.
Show all 9Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Soha Khadem, B.S. contact

720-853-4676

themovestudy@gmail.com

United States2 sites, 2 recruiting
  • Recreation Centers in the Denver Metro Area

    Aurora, Colorado, 80309

    Soha Khadem, B.S., 720-853-4676, themovestudy@gmail.com

    Recruiting
  • Recreation Centers in the Boulder Area

    Boulder, Colorado, 80309

    Soha Khadem, B.S., 720-853-4676, themovestudy@gmail.com

    Recruiting

Other trials in United States

About this study

Official title: 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.

Being tested
Goal Setting and Exercise Intensity Intervention
Keywords
Goals, Goal Difficulty, Exercise Intensity, Cognitive Decline
Medical subject headings
Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Goal Setting and Exercise Intensity InterventionBehavioural

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

Study groups in NCT07127965
Study groupRoleWhat they receive
Moderate Intensity Exercise, Basic Goal DifficultyExperimentalParticipants are assigned to exercise at a moderate intensity and create basic goals
Receives: Behavioral: Goal Setting and Exercise Intensity Intervention
Moderate Intensity Exercise, Challenging Goal DifficultyExperimentalParticipants are assigned to exercise at a moderate intensity and create challenging goals
Receives: Behavioral: Goal Setting and Exercise Intensity Intervention
Vigorous Intensity Exercise, Basic Goal DifficultyExperimentalParticipants are assigned to exercise at a vigorous intensity and create basic goals
Receives: Behavioral: Goal Setting and Exercise Intensity Intervention
Vigorous Intensity Exercise, Challenging Goal DifficultyExperimentalParticipants are assigned to exercise at a vigorous intensity and create challenging goals.
Receives: Behavioral: Goal Setting and Exercise Intensity Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Blood Pressure

    Blood pressure (systolic and diastolic) of all participants is collected before the intervention

    Measured: Baseline, Visit 15 (6 Months after baseline), Visit 17 (12 months after baseline)

  2. 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.

    Measured: Baseline, Visit 15 (6 months after baseline), Visit 17 (12 months after baseline)

  3. 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.

    Measured: Baseline, Visit 15 (6 months after baseline), Visit 17 (12 months after followup)

  4. 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.

    Measured: Baseline, Visit 15 (6 months after baseline), Visit 17 (12 months after baseline)

  5. 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.

    Measured: Baseline, Visit 17 (12 months after Baseline)

  6. Exercise Behavior

    modified Godin Shepard Leisure Time Physical Activity Questionnaire. Measures physical and leisure activity over a typical one week period

    Measured: All study timepoints (Visits 1-17; approximately 14 months)

  7. 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.

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

  8. 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.

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

  9. 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.

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

  10. 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.

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

  11. Theoretical Mediators of Exercise Behavior

    Exercise alignment with Black identity. Assessment of the extent to which 7 common exercises are aligned with Black identity

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

  12. Heart Rate Variability

    Heart Rate Variability is measured using chest strap monitor.

    Measured: Baseline, Visit 17 (12 months after Baseline)

  13. Heart Rate

    Heart Rate is measured using chest strap monitor.

    Measured: 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)

  14. Ventilatory Threshold

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

    Measured: Baseline

  15. 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).

    Measured: Baseline, Visits 2-13 (Supervised Exercise Training, 1 hour 3x/week for 4 weeks)

  16. 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).

    Measured: Visits 2, 6, 12 (Supervised Exercise Training)

  17. 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).

    Measured: Visit 12, Visits 14-16 (3, 6, and 9 months after baseline)

  18. 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).

    Measured: Visits 2, 6, 12 (Supervised Exercise Training)

  19. 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).

    Measured: Visits 2, 6, 12 (Supervised Exercise Training)

  20. 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

    Measured: Visits 14-17 (3, 6, 9, and 12 months after baseline)

  21. Exercise Benefits and Barriers

    A 10 item scale assessing perceived benefits of and barriers to exercise

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

  22. Anthropometrics

    Height will be measured in centimeters

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

  23. 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.

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

  24. Demographics

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

    Measured: Baseline

  25. 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).

    Measured: Baseline, Visit 15 (6 months after baseline), Visit 17 (12 months after baseline)

  26. 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.

    Measured: Baseline and Visit 17 (12 months after baseline)

  27. Anthropometrics

    Weight will be measured in pounds

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2025
  2. Study start5 Nov 2025
  3. Primary completion31 Aug 2028 (estimated)
  4. Study completion31 Aug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
226 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07127965
Sponsor's protocol ID
25-0479
Acronym
MOVE
Status last verified
Jun 2026
First submitted
7 Aug 2025
Last updated
11 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Goal Setting and Exercise Intensity Intervention in people with Cognitive Decline, run by University of Colorado, Boulder at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Soha Khadem, B.S. (720-853-4676, themovestudy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood Pressure (time frame: Baseline, Visit 15 (6 Months after baseline), Visit 17 (12 months after baseline)). The study lists 27 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.

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