Exercise Adherence and Cognitive Decline

NCT ID: NCT06769022

Last Updated: 2025-08-12

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2027-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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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 45-65.
* 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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of Colorado, Boulder

OTHER

Sponsor Role lead

Responsible Party

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Angela Bryan

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Aurora Center for Active Adults

Aurora, Colorado, United States

Site Status RECRUITING

University of Colorado at Boulder

Boulder, Colorado, United States

Site Status RECRUITING

Hiawatha Davis Jr. Recreation Center

Denver, Colorado, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Marin McCallen, BA

Role: CONTACT

(720)853-4676

Facility Contacts

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Marin McCallen, BA

Role: primary

720-853-4676

Marin McCallen, BA

Role: primary

(720)853-4676

Marin McCallen, BA

Role: primary

720-853-4676

Other Identifiers

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1R61AG078088-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

23-01-0205

Identifier Type: -

Identifier Source: org_study_id

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