Exercise in Men With Prostate Cancer

This study is currently recruiting participants.

Verified by University of Manitoba, October 2009

First Received: February 2, 2009 Last Updated: October 9, 2009 History of Changes

Sponsor:	University of Manitoba
Collaborator:	Manitoba Medical Service Foundation
Information provided by:	University of Manitoba
ClinicalTrials.gov Identifier:	NCT00834392

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:	Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment
Official Title:	A Pilot Study of Exercise in Men With Prostate Cancer Receiving Androgen Depletion Therapy

Resource links provided by NLM:

MedlinePlus related topics: Cancer Exercise and Physical Fitness Prostate Cancer

U.S. FDA Resources

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
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Control: No Intervention
Exercise: Experimental	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

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

Contacts

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

Locations

Canada, Manitoba
University of Manitoba	Recruiting
Winnipeg, Manitoba, Canada, R3E 0T6
Principal Investigator: C. Ellen Lee, PhD, PT

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

Responsible Party:	University of Manitoba ( C. Ellen Lee, PhD, PT, Assistant Professor )
Study ID Numbers:	H2008:035
Study First Received:	February 2, 2009
Last Updated:	October 9, 2009
ClinicalTrials.gov Identifier:	NCT00834392 History of Changes
Health Authority:	Canada: Ethics Review Committee

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on February 08, 2010