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Exercise for Physical Health in Men With Prostate Cancer

Primary Purpose

Prostatic Neoplasm, Osteoporosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Resistance Exercise
Flexibility Training
Sponsored by
OHSU Knight Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prostatic Neoplasm focused on measuring randomized clinical trial, elderly, cancer survivor, bone health, body composition, signs and symptoms, Androgen Deprivation Therapy

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • OHSU School of Nursing

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Progressive resistance training program 3 times a week for 12 months

Seated flexibility training 3 times a week for 12 months

Outcomes

Primary Outcome Measures

bone mineral density, bone turnover markers (serum osteocalcin, urinary deoxypyridinoline cross-links), muscle mass, fat mass.

Secondary Outcome Measures

maximal muscle strength, gait, balance, self-report physical function, symptoms

Full Information

First Posted
April 11, 2008
Last Updated
October 20, 2015
Sponsor
OHSU Knight Cancer Institute
Collaborators
Lance Armstrong Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00660686
Brief Title
Exercise for Physical Health in Men With Prostate Cancer
Official Title
Exercise for Physical Health in Men With Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OHSU Knight Cancer Institute
Collaborators
Lance Armstrong Foundation

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasm, Osteoporosis
Keywords
randomized clinical trial, elderly, cancer survivor, bone health, body composition, signs and symptoms, Androgen Deprivation Therapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Progressive resistance training program 3 times a week for 12 months
Arm Title
2
Arm Type
Active Comparator
Arm Description
Seated flexibility training 3 times a week for 12 months
Intervention Type
Behavioral
Intervention Name(s)
Resistance Exercise
Other Intervention Name(s)
Arm 1: N/A
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Flexibility Training
Other Intervention Name(s)
Arm 2: N/A
Intervention Description
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.
Primary Outcome Measure Information:
Title
bone mineral density, bone turnover markers (serum osteocalcin, urinary deoxypyridinoline cross-links), muscle mass, fat mass.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
maximal muscle strength, gait, balance, self-report physical function, symptoms
Time Frame
12 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kerri M Winters, PhD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
OHSU School of Nursing
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25194450
Citation
Winters-Stone KM, Dobek JC, Bennett JA, Dieckmann NF, Maddalozzo GF, Ryan CW, Beer TM. Resistance training reduces disability in prostate cancer survivors on androgen deprivation therapy: evidence from a randomized controlled trial. Arch Phys Med Rehabil. 2015 Jan;96(1):7-14. doi: 10.1016/j.apmr.2014.08.010. Epub 2014 Sep 3.
Results Reference
derived

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Exercise for Physical Health in Men With Prostate Cancer

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