Clinical trial NCT06769022: Exercise Adherence and Cognitive Decline
Official title: Exercise Adherence and Cognitive Decline: Engaging with the Black Community to Develop and Test a Goal-Setting and Exercise Intensity Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cognitive Decline
Keywords: Goals
Exercise Intensity
Goal Difficulty
Cognitive Decline
Lead sponsor: University of Colorado, Boulder
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2025-01-10
Enrollment: 22
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* \<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

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
* 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.

Primary outcomes:
measure: Blood Pressure
timeFrame: Baseline, Visit 14 (~2 months after baseline)
measure: Activity Levels
timeFrame: Baseline, Visit 14 (~2 months after baseline)
measure: Sleep levels
timeFrame: Baseline, Visit 14 (~2 months after baseline)
measure: Physical Activity Recall
timeFrame: Baseline, Visit 14 (~2 months after baseline)
measure: Identity
timeFrame: Baseline
measure: Exercise Behavior
timeFrame: Baseline, Visit 14 (~2 months after baseline)
measure: Exercise Behavior
timeFrame: Baseline, Visit 14 (~2 months after baseline)
measure: Theoretical Mediators of Exercise Behavior
timeFrame: Baseline, Visit 12 (~1 month after baseline), Visit 14 (~2 months after baseline)
measure: Theoretical Mediators of Exercise Behavior
timeFrame: Baseline, Visit 12 (~1 month after baseline), Visit 14 (~2 months after baseline)
measure: Theoretical Mediators of Exercise Behavior
timeFrame: Baseline, Visit 12 (~1 month after baseline), Visit 14 (~2 months after baseline)
measure: Theoretical Mediators of Exercise Behavior
timeFrame: Baseline, Visit 12 (~1 month after baseline), Visit 14 (~2 months after baseline)
measure: Heart Rate Variability
timeFrame: Baseline, Visit 14 (~2 months after baseline)
measure: Heart Rate
timeFrame: Baseline, Visits 1-14 (all visits)
measure: Physical Performance
timeFrame: Baseline, Visit 14 (~2 months after baseline)
measure: Ventilatory Threshold
timeFrame: Baseline
measure: Perceived Exertion
timeFrame: Visit 2-13 (~2 visits/week)
measure: Pain Levels
timeFrame: Visit 2-13 (~2 visits/week)
measure: Affective Valence
timeFrame: Visit 2-13 (~2 visits/week)
measure: Affective Arousal
timeFrame: Visit 2-13 (~2 visits/week)
measure: Enjoyment
timeFrame: Visit 2-13 (~2 visits/week)
measure: Exercise Check-In
timeFrame: Daily between visit 13 and 14 (~1 month)
measure: Study Feedback
timeFrame: Visit 14 (~2 months after baseline)
measure: Exercise Benefits and Barriers
timeFrame: Baseline, Visit 12 (~1 month after baseline), Visit 14 (~2 months after baseline)
measure: Anthropometrics
timeFrame: Baseline
measure: Exercise Aligned with Black Identity
timeFrame: Baseline
measure: Mental Status
timeFrame: Baseline
measure: Diet
timeFrame: Baseline
measure: Diet
timeFrame: Baseline
measure: Physical Activity
timeFrame: Baseline
Secondary outcomes:
measure: Demographics
timeFrame: Baseline
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Aurora Center for Active Adults
state: Colorado
city: Boulder
country: United States
facility: University of Colorado at Boulder
state: Colorado
city: Denver
country: United States
facility: Hiawatha Davis Jr. Recreation Center
state: Colorado
Study officials:
References: