Exercise in Men With Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

A Pilot Study of Exercise in Men With Prostate Cancer Receiving Androgen Depletion Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00834392
• Other study ID #: H2008:035
• Status: Completed
• Phase: N/A
• First received: February 2, 2009
• Last updated: January 31, 2011
• Start date: October 2008
• Est. completion date: December 2010

Study information

• Verified date: January 2011
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• Exercise
Walking exercise

Locations

Country	Name	City	State
Canada	University of Manitoba	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
University of Manitoba	Manitoba Medical Service Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bone health		baseline, 12 months	No