Exercise for Physical Health in Men With Prostate Cancer

Osteoporosis Clinical Trial

Official title:

Exercise for Physical Health in Men With Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00660686
• Other study ID #: 387
• Status: Completed
• Phase: N/A
• First received: April 11, 2008
• Last updated: October 20, 2015
• Start date: January 2006
• Est. completion date: January 2009

Study information

• Verified date: October 2015
• Source: OHSU Knight Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 100 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Osteoporosis
• Prostatic Neoplasm
• Prostatic Neoplasms

Intervention

Behavioral:
• Resistance Exercise
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
• Flexibility Training
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.

Locations

Country	Name	City	State
United States	OHSU School of Nursing	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
OHSU Knight Cancer Institute	Lance Armstrong Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bone mineral density, bone turnover markers (serum osteocalcin, urinary deoxypyridinoline cross-links), muscle mass, fat mass.		12 months	No
Secondary	maximal muscle strength, gait, balance, self-report physical function, symptoms		12 months	No