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Exercise in Men With Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00834392
Recruitment Status : Completed
First Posted : February 3, 2009
Last Update Posted : February 1, 2011
Manitoba Medical Service Foundation
Information provided by:
University of Manitoba

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Behavioral: Exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Study of Exercise in Men With Prostate Cancer Receiving Androgen Depletion Therapy
Study Start Date : October 2008
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: Control
Experimental: Exercise Behavioral: Exercise
Walking exercise

Primary Outcome Measures :
  1. bone health [ Time Frame: baseline, 12 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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).

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 identifier (NCT number): NCT00834392

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Canada, Manitoba
University of Manitoba
Winnipeg, Manitoba, Canada, R3E 0T6
Sponsors and Collaborators
University of Manitoba
Manitoba Medical Service Foundation
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Principal Investigator: C. Ellen Lee, PhD, PT University of Manitoba
Principal Investigator: Y.K. James Lau, MD, PhD CancerCare Manitoba
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: C. Ellen Lee, PhD, PT, Assistant Professor, University of Manitoba Identifier: NCT00834392    
Other Study ID Numbers: H2008:035
First Posted: February 3, 2009    Key Record Dates
Last Update Posted: February 1, 2011
Last Verified: January 2011
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases