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| Sponsors and Collaborators: |
Oregon Health and Science University Lance Armstrong Foundation |
|---|---|
| Information provided by: | Oregon Health and Science University |
| ClinicalTrials.gov Identifier: | NCT00660686 |
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: | Supportive Care, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Exercise for Physical Health in Men With Prostate Cancer |
| Estimated Enrollment: | 90 |
| Study Start Date: | January 2006 |
| Estimated Study Completion Date: | December 2008 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Progressive resistance training program 3 times a week for 12 months
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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
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2: Active Comparator
Seated flexibility training 3 times a week for 12 months
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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.
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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 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Oregon | |
| OHSU School of Nursing | |
| Portland, Oregon, United States, 97239 | |
| Principal Investigator: | Kerri M Winters, PhD | Oregon Health and Science University |
More Information
| Responsible Party: | Oregon Health & Science University ( Kerri Winters, PhD/ Associate Professor and Associate Scientist ) |
| Study ID Numbers: | 387 |
| Study First Received: | April 11, 2008 |
| Last Updated: | April 11, 2008 |
| ClinicalTrials.gov Identifier: | NCT00660686 |
| Health Authority: | United States: Institutional Review Board |
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randomized clinical trial elderly cancer survivor bone health |
body composition signs and symptoms Androgen Deprivation Therapy |
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Signs and Symptoms Prostatic Diseases Genital Neoplasms, Male Musculoskeletal Diseases Osteoporosis |
Urogenital Neoplasms Bone Diseases, Metabolic Genital Diseases, Male Bone Diseases Prostatic Neoplasms |
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Neoplasms Neoplasms by Site |
