| 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 |
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| 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. |
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| Interventional |
| Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment |
| Prostate Cancer |
| Behavioral: Exercise |
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| 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).
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| Male |
| 50 Years and older |
| No |
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| Canada |
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| 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 |
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| Principal Investigator: |
Y.K. James Lau, MD, PhD |
CancerCare Manitoba |
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| University of Manitoba |
| October 2009 |