Exercise for Physical Health in Men With Prostate Cancer

This study has been completed.
Sponsor:
Collaborator:
Lance Armstrong Foundation
Information provided by (Responsible Party):
Kerri Winters, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00660686
First received: April 11, 2008
Last updated: June 29, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Prostatic Neoplasm
Osteoporosis
Behavioral: Resistance Exercise
Behavioral: Flexibility Training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Exercise for Physical Health in Men With Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • bone mineral density, bone turnover markers (serum osteocalcin, urinary deoxypyridinoline cross-links), muscle mass, fat mass. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • maximal muscle strength, gait, balance, self-report physical function, symptoms [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: January 2006
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Progressive resistance training program 3 times a week for 12 months
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
Other Name: Arm 1: N/A
Active Comparator: 2
Seated flexibility training 3 times a week for 12 months
Behavioral: 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.
Other Name: Arm 2: N/A

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 POWIR program (Prevent Osteoporosis With Impact + Resistance) 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00660686

Locations
United States, Oregon
OHSU School of Nursing
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
Lance Armstrong Foundation
Investigators
Principal Investigator: Kerri M Winters, PhD Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Kerri Winters, Associate Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00660686     History of Changes
Other Study ID Numbers: 387
Study First Received: April 11, 2008
Last Updated: June 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:
randomized clinical trial
elderly
cancer survivor
bone health
body composition
signs and symptoms
Androgen Deprivation Therapy

Additional relevant MeSH terms:
Neoplasms
Osteoporosis
Prostatic Neoplasms
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on April 15, 2014