Back to resultsExercise in Men With Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer
Eligibility 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).
Sites / Locations
- University of Manitoba
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Exercise
Arm Description
Outcomes
Primary Outcome Measures
bone health
Secondary Outcome Measures
Full Information
NCT ID
NCT00834392
First Posted
February 2, 2009
Last Updated
January 31, 2011
Sponsor
University of Manitoba
Collaborators
Manitoba Medical Service Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00834392
Brief Title
Exercise in Men With Prostate Cancer
Official Title
A Pilot Study of Exercise in Men With Prostate Cancer Receiving Androgen Depletion Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Manitoba
Collaborators
Manitoba Medical Service Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Title
Exercise
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
Walking exercise
Primary Outcome Measure Information:
Title
bone health
Time Frame
baseline, 12 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
C. Ellen Lee, PhD, PT
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Y.K. James Lau, MD, PhD
Organizational Affiliation
CancerCare Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0T6
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
22436542
Citation
Lee CE, Leslie WD, Lau YK. A pilot study of exercise in men with prostate cancer receiving androgen deprivation therapy. BMC Cancer. 2012 Mar 21;12:103. doi: 10.1186/1471-2407-12-103.
Results Reference
derived
Learn more about this trial
Exercise in Men With Prostate Cancer
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