RecruitingPhase 1Phase 2NCT06237179

Behavioral Exercise Training to Reduce Cardiovascular Disease Risk

Behavioral Exercise Training to Reduce Cardiovascular Disease Risk in Men Undergoing Androgen Deprivation Therapy (EXTRA-PC)


Sponsor

Virginia Commonwealth University

Enrollment

60 participants

Start Date

Feb 21, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

To test the preliminary effectiveness of a home-based exercise training (ET) intervention to improve exercise capacity (VO2 peak \& 6-minute walk distance \[6MWD\]) among prostate cancer (PC) patients compared to controls receiving healthy living education (HLE) at 12 weeks.


Eligibility

Sex: MALEMin Age: 40 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a behavioral exercise training program to help reduce the risk of heart disease in men with prostate cancer who are receiving hormone therapy (called ADT). ADT can increase cardiovascular risk, and researchers want to see if structured exercise can help. **You may be eligible if...** - You have been diagnosed with stage II, III, or IV prostate cancer - You are currently on hormone therapy (ADT) - You have already completed local treatment such as surgery or radiation - You are between 40 and 85 years old - You can speak English and use a phone, computer, or smartphone - You are able to safely participate in an exercise program **You may NOT be eligible if...** - You cannot have an MRI (e.g., metal in your body, claustrophobia) - You have an existing heart condition or heart failure - You have an active infection or serious illness - Your blood counts (hemoglobin or platelets) are very low Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALExercise Training Intervention

5.1. The behavioral ET and HLE interventions will be delivered over 12 weeks. Before starting the study, men will be asked to attend one (1) in-person small group orientation to provide an overview of each intervention arm, familiarize them with web-based and smartphone applications or hard copy manuals for delivery of intervention content, exercise logs, resistance bands, and equipment for strength training.

BEHAVIORALHealthy Living Education

During the initial 12 weeks of the study, men randomized to the HLE group will receive educational modules delivered remotely (or manual and telephone call) in a group-based setting to approximately match contact frequency and structure with the ET arm.


Locations(2)

Richmond Veterans Affairs Medical Center

Richmond, Virginia, United States

Virginia Commonwealth University Massey Cancer Center

Richmond, Virginia, United States

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NCT06237179


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