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Exercise in Men With Prostate Cancer
This study is currently recruiting participants.
Study NCT00834392   Information provided by University of Manitoba
First Received: February 2, 2009   Last Updated: October 9, 2009   History of Changes

February 2, 2009
October 9, 2009
October 2008
December 2010   (final data collection date for primary outcome measure)
bone health [ Time Frame: baseline, 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00834392 on ClinicalTrials.gov Archive Site
 
 
 
Exercise in Men With Prostate Cancer
A Pilot Study of Exercise in Men With Prostate Cancer Receiving Androgen Depletion Therapy

The purpose of this pilot study is to compare a walking exercise program (Exercise Group) to standard medical care (Control Group) in prostate cancer survivors receiving androgen depletion therapy (ADT). The central hypothesis of the proposed research is that the walking exercise program will have a positive impact on the bone health, health-related quality of life, and physical function of men with prostate cancer receiving ADT.

 
 
Interventional
Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment
Prostate Cancer
Behavioral: Exercise
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
30
December 2010
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • men aged 50 years or older
  • diagnosed with adenocarcinoma prostate cancer
  • will initiate and receive continuous ADT (luteinizing hormone releasing hormone agonist (LHRH) or combination of LHRH and anti-androgen) for at least 12 months after recruitment
  • Patients will also consent to participating in the study.

Exclusion Criteria:

  • severe cardiac disease (New York Heart Association class III or greater)
  • angina
  • severe osteoporosis
  • uncontrolled hypertension (blood pressure > 160/95mm Hg)
  • orthostatic blood pressure drop > 20mm Hg
  • moderate to severe aortic stenosis
  • acute illness or fever
  • uncontrolled atrial or ventricular dysrhythmias
  • uncontrolled sinus tachycardia (> 120 beats per minute)
  • uncontrolled congestive heart failure third-degree atrio-ventricular heart block, active pericarditis or myocarditis, recent embolism, thrombophlebitis, deep vein thrombosis, resting ST displacement (> 3mm), uncontrolled diabetes, uncontrolled pain, cognitive impairment, history of falls due to balance impairment or lost of consciousness, severe neuromusculoskeletal conditions that limit their ability to perform walking exercise (including ataxia, peripheral or sensory neuropathy, unstable bone lesion, severe arthritis, pathological lower limb fractures within 6 months, lower limb amputation).
Male
50 Years and older
No
Contact: C. Ellen Lee, PhD, PT (204) 480-1397 celee@cc.umanitoba.ca
Contact: Y.K. James Lau, MD, PhD (204) 787-8959 James.Lau@cancercare.mb.ca
Canada
 
NCT00834392
C. Ellen Lee, PhD, PT, Assistant Professor, University of Manitoba
H2008:035
University of Manitoba
Manitoba Medical Service Foundation
Principal Investigator: C. Ellen Lee, PhD, PT University of Manitoba
Principal Investigator: Y.K. James Lau, MD, PhD CancerCare Manitoba
University of Manitoba
October 2009

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