Exercise for Physical Health in Men With Prostate Cancer

Not Applicable

Completed

• Conditions: Prostatic Neoplasm; Osteoporosis
• Interventions: Behavioral: Flexibility Training; Behavioral: Resistance Exercise

• Registration Number: NCT00660686
• Lead Sponsor: OHSU Knight Cancer Institute

Brief Summary

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

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.

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2008-04-11
• Study First Submitted QC: 2008-04-11
• Study First Posted: 2008-04-17
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-20
• Last Update Posted: 2015-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Flexibility Training	Seated flexibility training 3 times a week for 12 months
1	Resistance Exercise	Progressive resistance training program 3 times a week for 12 months

Primary Outcome Measures

Name	Time	Method
bone mineral density, bone turnover markers (serum osteocalcin, urinary deoxypyridinoline cross-links), muscle mass, fat mass.	12 months

Secondary Outcome Measures

Name	Time	Method
maximal muscle strength, gait, balance, self-report physical function, symptoms	12 months

Trial Locations

Locations (1)

OHSU School of Nursing; 🇺🇸 Portland, Oregon, United States