Exercise Adherence and Cognitive Decline: Phase 2
ConditionCognitive Decline
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-65
SponsorUniversity of Colorado, Boulder
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
<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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Goal Setting and Exercise Intensity Intervention
BehavioralParticipants' goal-setting and exercise intensity are manipulated based on group assignment.
Treatment groups
226 Participants
are divided into 4 treatment groupsGroup A: Moderate Intensity Exercise, Basic Goal DifficultyExperimental treatment 1 intervention
Group B: Moderate Intensity Exercise, Challenging Goal DifficultyExperimental treatment 1 intervention
Group C: Vigorous Intensity Exercise, Basic Goal DifficultyExperimental treatment 1 intervention
Group D: Vigorous Intensity Exercise, Challenging Goal DifficultyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Blood Pressure
Blood pressure (systolic and diastolic) of all participants is collected before the intervention
Time frame
Baseline, Visit 15 (6 Months after baseline), Visit 17 (12 months after baseline)2
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 15 (6 months after baseline), Visit 17 (12 months after baseline)3
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 15 (6 months after baseline), Visit 17 (12 months after followup)4
Exercise Intensity
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 15 (6 months after baseline), Visit 17 (12 months after baseline)Sponsors and contacts
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Source ClinicalTrials.gov