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Recruiting NCT07127965

Exercise Adherence and Cognitive Decline: Phase 2

No phase Interventional Cognitive Decline

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Goal Setting and Exercise Intensity Intervention.
Who it may be relevant to
Registry conditions: Cognitive Decline. Basic parameters: 45 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Exercise Adherence and Cognitive Decline: A Goal-setting and Exercise Intensity Intervention Collaboratively Developed With the Black Community

Overview

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.

Interventions

  • Behavioral Goal Setting and Exercise Intensity Intervention
    Participants' goal-setting and exercise intensity are manipulated based on group assignment.

Primary outcome measures

  • Blood Pressure [Time frame: Baseline, Visit 15 (6 Months after baseline), Visit 17 (12 months after baseline)]
  • Activity Levels [Time frame: Baseline, Visit 15 (6 months after baseline), Visit 17 (12 months after baseline)]
  • Sleep Levels [Time frame: Baseline, Visit 15 (6 months after baseline), Visit 17 (12 months after followup)]
  • Exercise Intensity [Time frame: Baseline, Visit 15 (6 months after baseline), Visit 17 (12 months after baseline)]
  • Exercise Behavior [Time frame: Baseline, Visit 17 (12 months after Baseline)]
  • Exercise Behavior [Time frame: All study timepoints (Visits 1-17; approximately 14 months)]
  • Theoretical Mediators of Exercise Behavior [Time frame: Baseline, Visit 12 (supervised exercise visit), Visits 14-17 (3, 6, 9, and 12 months after baseline)]
  • Theoretical Mediators of Exercise Behavior [Time frame: Baseline, Visit 12 (supervised exercise visit), Visits 14-17 (3, 6, 9, and 12 months after baseline)]
  • Theoretical Mediators of Exercise Behavior [Time frame: Baseline, Visit 12 (supervised exercise visit), Visits 14-17 (3, 6, 9, and 12 months after baseline)]
  • Theoretical Mediators of Exercise Behavior [Time frame: Baseline, Visit 12 (supervised exercise visit), Visits 14-17 (3, 6, 9, and 12 months after baseline)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 2 centers
  • Recreation Centers in the Denver Metro Area — Aurora
  • Recreation Centers in the Boulder Area — Boulder

Identifiers

NCT: NCT07127965 · 25-0479

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗