NCT06429813

Remotely Monitored Exercise Interventions in Patients with MCSPC Undergoing ADT (Prostate 006)

A Feasibility Study to Examine the Impact of Remotely Monitored Exercise Interventions on Cardiorespiratory/muscular Fitness and Fatigue in Patients with Metastatic Castrate-sensitive Prostate Cancer (mCSPC) Undergoing Treatment with Androgen-deprivation Therapy (ADT) Intensification

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Paul Viscuse · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study consists of two home-based exercise programs: a stationary exercise bicycle intervention (Arm A), and a walking intervention (Arm B). The study will enroll 24 patients who are starting ADT (Androgen Deprivation Therapy)/ARSI (Androgen-Receptor Signaling Inhibitors) therapy for newly diagnosed metastatic castrate-sensitive prostate cancer (mCSPC). All participants will be asked to complete 1-2 training sessions at UVA prior to starting the exercise. All participants will be asked to complete aerobic and strength testing before and after the exercise program. Participants will be asked to answer questionnaires throughout the program. The at-home exercise will last for 12 weeks.

Detailed description

The purpose of this study is to find out how many patients who are being treated for mCSPC complete one of two home-based exercise programs. The researchers want to find out how much exercise participants complete and how satisfied they are with the program. Another purpose of this study is to learn if doing the exercise changes fitness levels and/or muscle strength, and what relationship those changes might have on feeling tired during cancer treatment. Participants will be randomly assigned (like the flip of a coin) to one of two home-based exercise programs: * Arm A: A high intensity interval (HIIT) stationary bike program * Arm B: A walking program Participants in the cycling group (Arm A) will receive a stationary exercise bike for home exercise. All participants in the study (Arms A and B) will receive an activity monitor (watch) and a heart rate-monitoring chest strap that sends information back to the study team. Participants will receive 1-2 exercise training sessions, held in a UVA research lab, to allow them to experience the level of the exercise they will be asked to complete. Each participant will make a personal plan with the study team to gradually workup to the exercise goal assigned to each group. The research team will answer any questions and help set up the activity monitors. After these session(s), the remaining 12 weeks of exercise will occur at home.

Conditions

• Castrate Sensitive Prostate Cancer
• Metastatic Prostate Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Home-Based Exercise Intervention - Walking	30 minutes of walking or light jogging a day at a moderate intensity for 30 minutes a day, 5 days a week for 12 weeks
BEHAVIORAL	Home-Based Exercise Intervention - HIIT Cycling	Four, 4 minute high intensity intervals of exercise, separated by 3 minutes of lower intensity exercise + a 10 minute warm up and 5 minute cool down for 40 minutes a day, 3 days a week for 12 weeks

Timeline

• Start date: 2024-07-26
• Primary completion: 2025-11-01
• Completion: 2025-11-01
• First posted: 2024-05-28
• Last updated: 2025-02-21

Locations

1 site across 1 country: United States