Actively Recruiting
Behavioral Exercise Training to Reduce Cardiovascular Disease Risk in Men Undergoing Androgen Deprivation Therapy for Prostate Cancer
Led by Virginia Commonwealth University · Updated on 2026-03-02
60
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
V
Virginia Commonwealth University
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying men with prostate cancer who are undergoing androgen deprivation therapy ADT to see if a home-based exercise training program can improve their exercise capacity. The study compares this exercise program to a control group receiving healthy living education. The main goal is to measure improvements in maximal and sub-maximal exercise capacity after 12 weeks. Participants will be randomly assigned to one of two groups. The exercise training intervention is tailored to each mans fitness and strength to reach at least 150 minutes of moderate to vigorous physical activity per week. The healthy living education group will receive educational modules remotely or by phone in a group setting, matching the contact frequency of the exercise group. Both interventions last for 12 weeks, starting with an in-person orientation to introduce the program and tools. During the study, participants will complete assessments at baseline, 12 weeks, and 24 weeks. These include exercise tests measuring VO2 peak and 6-minute walk distance, heart function measures like stroke volume and ejection fraction, body composition, physical activity questionnaires, and quality of life surveys. The study will track changes in fatigue, sleep, mood, and physical function to evaluate the impact of the interventions. Safety and health status will be monitored throughout the trial, which runs until 2028.
CONDITIONS
Brief Title
Behavioral Exercise Training to Reduce Cardiovascular Disease Risk
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with stage II, III, or IV prostate cancer
- Currently undergoing androgen deprivation therapy (intermittent or prolonged)
- Completed local curative-intent treatment such as prostatectomy or definitive radiation
- Aged between 40 and 85 years
- Willing to sign informed consent with HIPAA authorization
- No hearing or sight impairments that prevent using telephone or hearing normal conversation
- Able to join intervention groups by computer, smartphone, or phone call and agree to interview recording
- Without serious medical conditions that make exercise unsafe
- Able to speak English
You will not qualify if you...
- Unable to undergo MRI (due to ferromagnetic materials, inability to lie flat, or claustrophobia)
- Contraindications to exercise testing
- Pre-existing overt cardiovascular disease or heart failure
- Active illness or infection
- Hemoglobin level less than 7.0 grams per deciliter
- Platelet count less than 10 x 10^9/L
Research Team
A
Alexander R Lucas, PhD
A
Alexandra Marshall, MS
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