Exercise in Men With Prostate Cancer

This study has been completed.
Sponsor:
Collaborator:
Manitoba Medical Service Foundation
Information provided by:
University of Manitoba
ClinicalTrials.gov Identifier:
NCT00834392
First received: February 2, 2009
Last updated: January 31, 2011
Last verified: January 2011
  Purpose

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 Intervention
Prostate Cancer
Behavioral: Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Study of Exercise in Men With Prostate Cancer Receiving Androgen Depletion Therapy

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • bone health [ Time Frame: baseline, 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: October 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Experimental: Exercise Behavioral: Exercise
Walking exercise

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00834392

Locations
Canada, Manitoba
University of Manitoba
Winnipeg, Manitoba, Canada, R3E 0T6
Sponsors and Collaborators
University of Manitoba
Manitoba Medical Service Foundation
Investigators
Principal Investigator: C. Ellen Lee, PhD, PT University of Manitoba
Principal Investigator: Y.K. James Lau, MD, PhD CancerCare Manitoba
  More Information

No publications provided by University of Manitoba

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: C. Ellen Lee, PhD, PT, Assistant Professor, University of Manitoba
ClinicalTrials.gov Identifier: NCT00834392     History of Changes
Other Study ID Numbers: H2008:035
Study First Received: February 2, 2009
Last Updated: January 31, 2011
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on October 19, 2014