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Exercise Adherence and Cognitive Decline: Phase 2

This study is testing a program called "Goal Setting and Exercise Intensity Intervention" to help Black adults aged 45-65 exercise more. The program was developed with input from the Black community. Researchers want to see if this program can improve activity levels, blood pressure, and sleep over 12 months. They are looking for 226 participants who are not currently very active and live in the Denver area. The goal is to address health issues like cognitive decline, which can be affected by low physical activity, especially in communities of color.

Study design
This is an interventional study with 226 planned participants. It is testing a behavioral intervention.
What's involved
Participants will have measurements taken at the start, then at 6 months, and again at 12 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months after starting the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07127965

Exercise Adherence and Cognitive Decline: Phase 2

Recruiting
NAAges 45–65InterventionalPrevention
University of Colorado, Boulder
~226 participants
Updated 2026-06-11 on ClinicalTrials.gov
What's tested:Goal Setting and Exercise Intensity Intervention

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Blood Pressure
Measured over Baseline, Visit 15 (6 Months after baseline), Visit 17 (12 months after baseline)
+26 more outcomes measured

Conditions

Cognitive Decline

Explore related trials

Cognitive Dysfunction

NCT07127965

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Recreation Centers in the Boulder Area

    Boulder, Coloradostudy coordinator listed

    Recruiting

  • Recreation Centers in the Denver Metro Area

    Aurora, Coloradostudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Soha Khadem, B.S.
[email protected]
720-853-4676
Email the study team

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Eligibility criteria

Inclusion

\<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

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
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

What this trial measures

  • Blood PressureBaseline, 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

  • Activity LevelsBaseline, 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.

  • Sleep LevelsBaseline, 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.

  • Exercise IntensityBaseline, 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.

  • Exercise BehaviorBaseline, 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.

  • Exercise BehaviorAll 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

  • Theoretical Mediators of Exercise BehaviorBaseline, 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.

  • Theoretical Mediators of Exercise BehaviorBaseline, 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.

  • Theoretical Mediators of Exercise BehaviorBaseline, 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.

  • Theoretical Mediators of Exercise BehaviorBaseline, 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.

  • Theoretical Mediators of Exercise BehaviorBaseline, 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

  • Heart Rate VariabilityBaseline, Visit 17 (12 months after Baseline)

    Heart Rate Variability is measured using chest strap monitor.

  • Heart RateBaseline, 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.

  • Ventilatory ThresholdBaseline

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

  • Perceived ExertionBaseline, 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).

  • Pain LevelsVisits 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).

  • Affective ValenceVisit 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).

  • Affective ArousalVisits 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).

  • EnjoymentVisits 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).

  • Exercise Check-InVisits 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

  • Exercise Benefits and BarriersBaseline, 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

  • AnthropometricsBaseline, Visit 17 (12-month follow-up)

    Height will be measured in centimeters

  • DietBaseline, 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.

  • DemographicsBaseline

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

  • Objective Physical ActivityBaseline, 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).

  • Biomarkers of Cognitive AgingBaseline 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.

  • AnthropometricsBaseline, Visit 17 (12-month follow-up)

    Weight will be measured in pounds