Exercise Adherence and Cognitive Decline: Phase 2 (MOVE)

University of Colorado Boulder (CU)

Status: Enrolling

Conditions: Cognitive Decline

Treatments: Behavioral: Goal Setting and Exercise Intensity Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT07127965

25-0479

Details and patient eligibility

About

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.

Enrollment: 226 estimated patients

Sex: All

Ages: 45 to 65 years old

Volunteers: Accepts Healthy Volunteers

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 Exclusion Criteria:

• Answers "yes" to 1 or more of the 7 general questions of the PAR-Q+ and answers yes to any of the follow up questions.
• Blood pressure at baseline is greater than 160/100
• Blood pressure at baseline is between 140/90 - 160/100 and the participant is currently taking blood pressure medication
• Blood pressure > 210/90 mmHg (for men) or > 190/90 mmHg (for women) immediately after exercise

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

226 participants in 4 patient groups

Moderate Intensity Exercise, Basic Goal Difficulty

Experimental group

Description:

Participants are assigned to exercise at a moderate intensity and create basic goals

Treatment:

Behavioral: Goal Setting and Exercise Intensity Intervention

Moderate Intensity Exercise, Challenging Goal Difficulty

Experimental group

Description:

Participants are assigned to exercise at a moderate intensity and create challenging goals

Treatment:

Behavioral: Goal Setting and Exercise Intensity Intervention

Vigorous Intensity Exercise, Basic Goal Difficulty

Experimental group

Description:

Participants are assigned to exercise at a vigorous intensity and create basic goals

Treatment:

Behavioral: Goal Setting and Exercise Intensity Intervention

Vigorous Intensity Exercise, Challenging Goal Difficulty

Experimental group

Description:

Participants are assigned to exercise at a vigorous intensity and create challenging goals.

Treatment:

Behavioral: Goal Setting and Exercise Intensity Intervention