NCT03672396

Home-based Exercise Intervention for Patients With Metastatic Prostate Cancer

Feasibility Study of a Home-Based Exercise Intervention Program for Patients With Metastatic Castration-Resistant Prostate Cancer Receiving Androgen Deprivation Therapy (ADT)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: UNC Lineberger Comprehensive Cancer Center · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This single arm, multi-site pilot study aims to evaluate the feasibility of recruiting and adherence to a 12 week home-based exercise intervention to be conducted in men with metastatic castration resistant prostate cancer (mCRPC) receiving androgen deprivation therapy (ADT). Thirty patients will be enrolled, with the expectation that 20-25 will complete all follow-up measures.

Detailed description

The purpose of this trial is to evaluate the feasibility and adherence to a home-based 12 week exercise intervention in mCRPC patients receiving ADT. It will also examine if a home-based exercise intervention can improve muscle strength, body composition, physical function, cardiopulmonary function fatigue, and patient reported outcomes (fatigue, depression, quality of life (QoL)).

Conditions

• Castration-resistant Prostate Cancer
• Androgen Deprivation Therapy

Interventions

Type	Name	Description
BEHAVIORAL	Home-based exercise	The intervention consists of aerobic and strength training \~3 times per week for 12 weeks with each session lasting 1 hour. The progressive aerobic exercise will involve walking that varies from from 15 to 30 minutes done 2-4 times per week at an intensity from 40% to 65% of heart rate reserve. Therabands elastic bands will be used to perform 12 to 15 repetitions per exercise. Once a participant can comfortably complete 15 repetitions for all prescribed sets, they will increase resistance by moving up to the next band. The training volume increased from 1 set per exercise on week 1 to 3 sets by week 12.

Timeline

• Start date: 2017-04-01
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2018-09-14
• Last updated: 2021-04-20
• Results posted: 2021-01-12

Locations

2 sites across 1 country: United States