Exercise Adherence and Cognitive Decline: Phase 2

NCT ID: NCT07127965

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

226 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-05

Study Completion Date

2028-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cognitive Decline

Keywords

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Goals Goal Difficulty Exercise Intensity Cognitive Decline

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Moderate Intensity Exercise, Basic Goal Difficulty

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

Group Type EXPERIMENTAL

Goal Setting and Exercise Intensity Intervention

Intervention Type BEHAVIORAL

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

Moderate Intensity Exercise, Challenging Goal Difficulty

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

Group Type EXPERIMENTAL

Goal Setting and Exercise Intensity Intervention

Intervention Type BEHAVIORAL

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

Vigorous Intensity Exercise, Basic Goal Difficulty

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

Group Type EXPERIMENTAL

Goal Setting and Exercise Intensity Intervention

Intervention Type BEHAVIORAL

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

Vigorous Intensity Exercise, Challenging Goal Difficulty

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

Group Type EXPERIMENTAL

Goal Setting and Exercise Intensity Intervention

Intervention Type BEHAVIORAL

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

Interventions

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Goal Setting and Exercise Intensity Intervention

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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


* 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
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Colorado, Boulder

OTHER

Sponsor Role lead

Responsible Party

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Angela Bryan

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Recreation Centers in the Denver Metro Area

Aurora, Colorado, United States

Site Status RECRUITING

University of Colorado at Boulder

Boulder, Colorado, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Sarah Frances Crawford, B.A.

Role: CONTACT

Phone: 423-771-1244

Email: [email protected]

Facility Contacts

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Sarah Frances Crawford, B.A

Role: primary

Sarah Frances Crawford, B.A.

Role: primary

Other Identifiers

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25-0479

Identifier Type: -

Identifier Source: org_study_id