Exercise Adherence and Cognitive Decline

NCT06769022 | Recruiting

• 2 other identifiers: 23-01-02051R61AG078088-01A1
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Cognitive Decline

Keywords

Goals; Exercise Intensity; Goal Difficulty; Cognitive Decline

Outcome Measures

Primary Outcomes (29)

• 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 Outcomes (1)

• Demographics

  Baseline

Study Arms (4)

Moderate Intensity Exercise, Basic Goal Difficulty

EXPERIMENTAL

Participants are assigned to exercise at a moderate intensity and create basic goals.

Behavioral: Goal Setting and Exercise Intensity Intervention

Moderate Intensity Exercise, Challenging Goal Difficulty

EXPERIMENTAL

Participants are assigned to exercise at a moderate intensity and create challenging goals.

Behavioral: Goal Setting and Exercise Intensity Intervention

Vigorous Intensity Exercise, Basic Goal Difficulty

EXPERIMENTAL

Participants are assigned to exercise at a vigorous intensity and create basic goals.

Behavioral: Goal Setting and Exercise Intensity Intervention

Vigorous Intensity Exercise, Challenging Goal Difficulty

EXPERIMENTAL

Participants are assigned to exercise at a vigorous intensity and create challenging goals.

Behavioral: Goal Setting and Exercise Intensity Intervention

Interventions

Goal Setting and Exercise Intensity Intervention BEHAVIORAL

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

Moderate Intensity Exercise, Basic Goal Difficulty; Moderate Intensity Exercise, Challenging Goal Difficulty; Vigorous Intensity Exercise, Basic Goal Difficulty; Vigorous Intensity Exercise, Challenging Goal Difficulty

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \<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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Boulder: lead
• National Institute on Aging (NIA): collaborator

Study Sites (3)

Aurora Center for Active Adults

Aurora, Colorado, 80011, United States

RECRUITING

University of Colorado at Boulder

Boulder, Colorado, 80309, United States

RECRUITING

Hiawatha Davis Jr. Recreation Center

Denver, Colorado, 80207, United States

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Marin McCallen, BA

CONTACT

(720)853-4676; marin.mccallen@colorado.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: January 10, 2025
• Study Start: October 1, 2024
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: August 12, 2025

Record last verified: 2025-08

Locations

US (3)