Cognitive Decline
Conditions
Keywords
Goals, Goal Difficulty, Exercise Intensity, Cognitive Decline
Brief summary
The purpose of this study is to conduct a test of a goals-based program to help people exercise more. This program was 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.
Interventions
Participants' goal-setting and exercise intensity are manipulated based on group assignment.
Sponsors
University of Colorado, Boulder
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* \<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 criteria
* 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 PCP
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Pressure | 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 | 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 | 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 | 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 | 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. |
| Theoretical Mediators of Exercise Behavior | 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. |
| Heart Rate Variability | Baseline, Visit 17 (12 months after Baseline) | Heart Rate Variability is measured using chest strap monitor. |
| Heart Rate | 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 | Baseline | Talk Test. Graded treadmill test where intensity is increased at intervals to determine participant's ventilatory threshold. |
| Perceived Exertion | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Baseline, Visit 17 (12-month follow-up) | Height will be measured in centimeters |
| Diet | 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 | Baseline | Survey includes gender, sexual orientation, age, detailed race/ethnicity, and SES |
| Objective Physical Activity | 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 | 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. |
Countries
United States
Contacts
CONTACTSoha Khadem, B.S.
Outcome results
None listed