NCT00834392CompletedNot Applicable
A Pilot Study of Exercise in Men With Prostate Cancer Receiving Androgen Depletion Therapy
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Manitoba
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- bone health
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- 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)
- •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).
Arms & Interventions
Exercise
Experimental
Intervention: Exercise (Behavioral)
Control
No Intervention
Outcomes
Primary Outcomes
bone health
Time Frame: baseline, 12 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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