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Exercise for Physical Health in Men With Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00660686
Recruitment Status : Completed
First Posted : April 17, 2008
Last Update Posted : October 21, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Prostatic Neoplasm Osteoporosis Behavioral: Resistance Exercise Behavioral: Flexibility Training

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Exercise for Physical Health in Men With Prostate Cancer
Study Start Date : January 2006
Primary Completion Date : January 2009
Study Completion Date : January 2009

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. bone mineral density, bone turnover markers (serum osteocalcin, urinary deoxypyridinoline cross-links), muscle mass, fat mass. [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. maximal muscle strength, gait, balance, self-report physical function, symptoms [ Time Frame: 12 months ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00660686


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT00660686     History of Changes
Other Study ID Numbers: 387
First Posted: April 17, 2008    Key Record Dates
Last Update Posted: October 21, 2015
Last Verified: October 2015

Keywords provided by OHSU Knight Cancer Institute:
randomized clinical trial
elderly
cancer survivor
bone health
body composition
signs and symptoms
Androgen Deprivation Therapy

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