Exercise Adherence and Cognitive Decline: Phase 2

BEHAVIORAL

Goal Setting and Exercise Intensity Intervention

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

Blood Pressure

Time frame: Baseline, 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 Levels

Time frame: Baseline, 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 Levels

Time frame: Baseline, 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 Intensity

Time frame: Baseline, 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 Behavior

Time frame: Baseline, 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 Behavior

Time frame: All 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 Behavior

Time frame: Baseline, 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 Behavior

Time frame: Baseline, 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 Behavior

Time frame: Baseline, 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 Behavior

Time frame: Baseline, 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 Behavior

Time frame: Baseline, 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 Variability

Time frame: Baseline, Visit 17 (12 months after Baseline)

Heart Rate Variability is measured using chest strap monitor.

Heart Rate

Time frame: 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)

Heart Rate is measured using chest strap monitor.

Ventilatory Threshold

Time frame: Baseline

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

Perceived Exertion

Time frame: Baseline, 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 Levels

Time frame: Visits 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 Valence

Time frame: Visit 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 Arousal

Time frame: Visits 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).

Enjoyment

Time frame: Visits 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-In

Time frame: Visits 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 Barriers

Time frame: Baseline, 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

Anthropometrics

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

Height will be measured in centimeters

Diet

Time frame: Baseline, 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.

Demographics

Time frame: Baseline

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

Objective Physical Activity

Time frame: Baseline, 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 Aging

Time frame: Baseline 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.

Anthropometrics

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

Weight will be measured in pounds

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Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

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How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.