NCT06237179

Behavioral Exercise Training to Reduce Cardiovascular Disease Risk

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: Male
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer
• Supportive Care

Interventions

Type	Name	Description
BEHAVIORAL	Exercise 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.
BEHAVIORAL	Healthy 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.

Timeline

• Start date: 2024-02-21
• Primary completion: 2028-01-31
• Completion: 2028-01-31
• First posted: 2024-02-01
• Last updated: 2026-03-02

Locations

2 sites across 1 country: United States