An interventional study of Goal Setting and Exercise Intensity Intervention in Cognitive Decline, sponsored by University of Colorado, Boulder. Completed at 3 sites in United States. Open to participants aged 45 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-11.
Sponsored by University of Colorado, Boulder · Not applicable, Interventional, and Prevention
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.
3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.
This study's enrollment of 21 is below the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →University of Colorado, Boulder is the lead sponsor of 86 studies on the registry; 20 are open to participants now.
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Exclusion Criteria:
Participants are assigned to exercise at a moderate intensity and create basic goals.
Behavioral: Goal Setting and Exercise Intensity Intervention
Participants are assigned to exercise at a moderate intensity and create challenging goals.
Behavioral: Goal Setting and Exercise Intensity Intervention
Participants are assigned to exercise at a vigorous intensity and create basic goals.
Behavioral: Goal Setting and Exercise Intensity Intervention
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.
Blood Pressure
Blood pressure of all participants is collected before intervention
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Visit 14 (~2 months after baseline)
Heart Rate
HR is measured using chest strap monitor.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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
Time frame: 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
Time frame: Visit 14 (~2 months after baseline)
Exercise Benefits and Barriers
A 10 item scale assessing perceived benefits of and barriers to exercise
Time frame: Baseline, Visit 12 (~1 month after baseline), Visit 14 (~2 months after baseline)
Anthropometrics
Height, weight, waist circumference, and hip circumference will be measured
Time frame: Baseline
Exercise Aligned with Black Identity
Assessment of the extent to which 7 common exercises are aligned with Black identity
Time frame: Baseline
Mental Status
Pfeiffer Mental Status. Assessment of cognitive deficits at baseline.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Baseline
Demographics
Survey includes sex assigned at birth, gender identity, sexual orientation, age, detailed race/ethnicity, and SES
Time frame: Baseline
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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University of Colorado, Boulder