Exercise for Physical Health in Men With Prostate Cancer

Study Overview
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Brief Summary
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The purpose of this study is to conduct a 12-month randomized controlled trial comparing the effects of strength and impact exercise training to flexibility/relaxation training on body composition (bone, muscle and fat mass), physical function (strength, gait, power, balance and self-report physical function and symptoms) in men currently treated with hormone therapy for prostate cancer.

Detailed Description
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Prostate cancer survivors with advanced disease are commonly treated with androgen deprivation therapy (ADT) to reduce testosterone. Serious side effects of ADT are rapid bone and muscle loss that can lead to osteoporosis and declines in neuromuscular function (strength, power, gait and balance) which increases the risk of fracture and falls (a risk factor for fracture) and impairs physical function. Men on ADT are 1.4 times more likely to fracture compared with their cancer-free peers and those who fracture have a poorer prognosis than those who do not. Self-report physical function is also lower among men on ADT. Exercise can prevent bone loss, neuromuscular declines and falls in several populations. However, the ability of exercise to prevent bone loss from ADT has not been tested, while data on exercise and neuromuscular function (strength only) in this population are limited to one published trial. The long-term goal of our research is to improve musculoskeletal health and function in cancer survivors. Critical first steps to meet this goal are to determine whether our previously tested program of impact and resistance exercise, shown to improve bone health and neuromuscular function in women, can prevent bone loss and neuromuscular declines in prostate cancer survivors on ADT. Based on our previous research, we have developed the Prevent Osteoporosis With Impact + Resistance (POWIR) program to be adapted to clinical populations at risk for bone loss and declines in neuromuscular function. Potentially, POWIR could mitigate bone and muscle losses from ADT, and thereby lower fracture risk and improve quality of life.

Official Title
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Exercise for Physical Health in Men With Prostate Cancer

Conditions
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Prostatic Neoplasm, Osteoporosis

Intervention / Treatment
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* Behavioral: Resistance Exercise
* Behavioral: Flexibility Training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: histologically confirmed prostate cancer presently receiving or planning to begin androgen deprivation therapy for prostate cancer Exclusion Criteria: Presence of bone metastases in the proximal femur and lumbar spine Clinically defined osteoporosis Current or previous use of medications known to affect bone metabolism Current regular participation (>2x/wk for at least 30 min/session) in a planned session of moderate-vigorous impact or resistance training A medical condition, disorder, or medication that contraindicates participation in moderate intensity impact or resistance exercise

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Progressive resistance training program 3 times a week for 12 months | Behavioral: Resistance Exercise<br>* 60 minute sessions 3 times a week of moderate-vigorous lower and upper body free-weight strength training plus impact training (jumps). Two of the three sessions are conducted in a supervised setting at a university fitness facility and the third session is a modified version of the exercise program performed at home. Participants are in the exercise program for 12 months<br>* Other names: Arm 1: N/A;|
| Active Comparator: 2<br>Seated flexibility training 3 times a week for 12 months | Behavioral: Flexibility Training<br>* 60 minute session 3 times a week focusing on whole body flexibility (stretching) and relaxation (progressive neuromuscular relaxation, focused breathing) exercises. Exercises are selected to be non-weight bearing and require minimal muscle strength in order to provide a contrast to the intervention arm. Two sessions are conducted in a supervised setting at a university fitness center and the third is a home-based version of the program performed at home.<br>* Other names: Arm 2: N/A;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bone mineral density, bone turnover markers (serum osteocalcin, urinary deoxypyridinoline cross-links), muscle mass, fat mass. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maximal muscle strength, gait, balance, self-report physical function, symptoms |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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randomized clinical trial, elderly, cancer survivor, bone health, body composition, signs and symptoms, Androgen Deprivation Therapy