NCT02248350

An Exercise Intervention for Prostate Cancer Patients Receiving Androgen Deprivation Therapy

An Exercise Intervention to Mitigate Side-Effects Related to Androgen Deprivation Therapy Among Prostate Cancer Survivors.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Georgetown University · Academic / Other
• Sex: Male
• Age: 40 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This main purpose of this study is to examine the effects of an exercise intervention to counteract adverse side effects related to Androgen Deprivation Therapy (ADT) in prostate cancer patients. Specifically, a supervised and home-based exercise program will be used to assess its impact on clinical and behavioral variables related to ADT in prostate cancer patients.

Detailed description

This study will assess the feasibility of an exercise intervention to counteract adverse side effects related to ADT in prostate cancer (PCa) patients. Specifically, we will use an exercise intervention and assess its impact on bone mass density, Body Mass Index (BMI), hip/waist circumference levels, biomarkers (i.e., glucose, lipids), step count, grip strength, and health-related quality of life (HRQOL) using the Patient Reported Outcomes Measurement Information System (PROMIS®). In this 8-week two-arm randomized clinical trial, 40 PCa patients receiving ADT will be randomly assigned to an exercise (n=20) or a stretching control group (n=20) with a follow-up at 8-weeks.

Conditions

• Prostate Cancer
• Physical Activity
• Side-effects

Interventions

Type	Name	Description
BEHAVIORAL	Supervised and Home Based Exercise	Participants will come to our community based research office for up to 50 min/session, 3-days/week of supervised exercise for 8-weeks. The exercise intensity will be tailored between 60-80% of their VO2max, as determined during baseline testing and with a rating of perceived exertion (RPE) of 11-14 on the 20-point scale.
BEHAVIORAL	Stretching Control Group	Participants randomized into the control group will be provided an informational booklet with stretching techniques and exercises and will be asked to stretch at least 20-minutes a day for the duration of the study.

Timeline

• Start date: 2014-09-01
• Primary completion: 2017-09-01
• Completion: 2017-09-01
• First posted: 2014-09-25
• Last updated: 2018-02-15

Locations

1 site across 1 country: United States