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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:
Lance Armstrong Foundation
Information provided by (Responsible Party):
OHSU Knight Cancer Institute

Tracking Information
First Submitted Date  ICMJE April 11, 2008
First Posted Date  ICMJE April 17, 2008
Last Update Posted Date October 21, 2015
Study Start Date  ICMJE January 2006
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 11, 2008)
bone mineral density, bone turnover markers (serum osteocalcin, urinary deoxypyridinoline cross-links), muscle mass, fat mass. [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 11, 2008)
maximal muscle strength, gait, balance, self-report physical function, symptoms [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exercise for Physical Health in Men With Prostate Cancer
Official Title  ICMJE Exercise for Physical Health in Men With Prostate Cancer
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Prostatic Neoplasm
  • Osteoporosis
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: 1
    Progressive resistance training program 3 times a week for 12 months
    Intervention: Behavioral: Resistance Exercise
  • Active Comparator: 2
    Seated flexibility training 3 times a week for 12 months
    Intervention: Behavioral: Flexibility Training
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 29, 2012)
56
Original Estimated Enrollment  ICMJE
 (submitted: April 11, 2008)
90
Actual Study Completion Date  ICMJE January 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00660686
Other Study ID Numbers  ICMJE 387
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party OHSU Knight Cancer Institute
Study Sponsor  ICMJE OHSU Knight Cancer Institute
Collaborators  ICMJE Lance Armstrong Foundation
Investigators  ICMJE
Principal Investigator: Kerri M Winters, PhD Oregon Health and Science University
PRS Account OHSU Knight Cancer Institute
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP