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Cognitive DeclineMOVENCT06769022

Exercise Adherence and Cognitive Decline

A study testing Goal Setting and Exercise Intensity Intervention in people with Cognitive Decline, run by University of Colorado, Boulder at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. 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
21 participants
Where
3 sitesUnited States
Study dates
1 Oct 2024to 7 Jul 2025
Phase
Interventional
Are there results?
None posted in the registry

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 45-65.
  • 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

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
  • 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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites
  • Aurora Center for Active Adults

    Aurora, Colorado, 80011

  • University of Colorado at Boulder

    Boulder, Colorado, 80309

  • Hiawatha Davis Jr. Recreation Center

    Denver, Colorado, 80207

Other trials in United States

About this study

Official title: 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.

Being tested
Goal Setting and Exercise Intensity Intervention
Keywords
Goals, Exercise Intensity, Goal Difficulty, 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 NCT06769022
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 of all participants is collected before intervention

    Measured: Baseline, Visit 14 (~2 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 14 (~2 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 14 (~2 months after baseline)

  4. 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.

    Measured: Baseline, Visit 14 (~2 months after baseline)

  5. 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.

    Measured: Baseline

  6. Exercise Behavior

    CHAMPS. The survey collects quantitative data looking at the approximate total hours per week spent doing various activities, both physical and social.

    Measured: Baseline, Visit 14 (~2 months after baseline)

  7. 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 14 (~2 months after baseline)

  8. 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 (~1 month after baseline), Visit 14 (~2 months after baseline)

  9. 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 (~1 month after baseline), Visit 14 (~2 months after baseline)

  10. 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 (~1 month after baseline), Visit 14 (~2 months after baseline)

  11. 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 (~1 month after baseline), Visit 14 (~2 months after baseline)

  12. Heart Rate Variability

    Heart Rate Variability is measured using chest strap monitor.

    Measured: Baseline, Visit 14 (~2 months after baseline)

  13. Heart Rate

    HR is measured using chest strap monitor.

    Measured: Baseline, Visits 1-14 (all visits)

  14. Physical Performance

    Short Physical Performance Battery. Physical performance measured with repeated chair stands, three balance tests (side-by-side, semi-tandem, tandem), timed walking.

    Measured: Baseline, Visit 14 (~2 months after baseline)

  15. Ventilatory Threshold

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

    Measured: Baseline

  16. 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: Visit 2-13 (~2 visits/week)

  17. 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: Visit 2-13 (~2 visits/week)

  18. 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 2-13 (~2 visits/week)

  19. 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: Visit 2-13 (~2 visits/week)

  20. 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: Visit 2-13 (~2 visits/week)

  21. 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: Daily between visit 13 and 14 (~1 month)

  22. Study Feedback

    An investigator led interview to pilot study participants' experience of the intervention and suggestions for improvement

    Measured: Visit 14 (~2 months after baseline)

  23. Exercise Benefits and Barriers

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

    Measured: Baseline, Visit 12 (~1 month after baseline), Visit 14 (~2 months after baseline)

  24. Anthropometrics

    Height, weight, waist circumference, and hip circumference will be measured

    Measured: Baseline

  25. Exercise Aligned with Black Identity

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

    Measured: Baseline

  26. Mental Status

    Pfeiffer Mental Status. Assessment of cognitive deficits at baseline.

    Measured: Baseline

  27. Diet

    Nutrition Data System for Research (NDSR) 24-Hour Dietary Recall. Interviewer administered recall developed by the University of Minnesota Nutrition Coordinating Center (NCC).

    Measured: Baseline

  28. 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.

    Measured: Baseline

  29. 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.

    Measured: Baseline

Secondary outcomes (1)
  1. Demographics

    Survey includes sex assigned at birth, gender identity, sexual orientation, age, detailed race/ethnicity, and SES

    Measured: Baseline

Timeline

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

  1. First posted10 Jan 2025
  2. Study start1 Oct 2024
  3. Primary completion7 Jul 2025
  4. Study completion7 Jul 2025

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
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06769022
Sponsor's protocol ID
23-01-0205
Other IDs
1R61AG078088-01A1
Acronym
MOVE
Status last verified
Jun 2026
First submitted
3 Dec 2024
Last updated
11 Jun 2026
Results posted
No
Data monitoring committee
No
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 3 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 7 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: finished, 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 3 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood Pressure (time frame: Baseline, Visit 14 (~2 months after baseline)). The study lists 29 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; AzTrials last refreshed its copy on 28 Oct 2026.

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