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Exercise and Cognitive-psychosocial Functions in Men With Prostate Cancer Receiving Androgen Depletion Therapy

This study has been completed.
Sponsor:
Collaborator:
Health Sciences Centre Foundation, Manitoba
Information provided by:
University of Manitoba
ClinicalTrials.gov Identifier:
NCT00856102
First received: March 3, 2009
Last updated: January 31, 2011
Last verified: January 2011
History of Changes
  Purpose

The objective of the proposed research is to determine the efficacy of a home-based walking exercise program in promoting cognitive-psychosocial functions of men with prostate cancer receiving androgen depletion therapy (ADT). ADT is the mainstay treatment for men with advanced prostate cancer. However, ADT has a number of side effects including compromised cognitive function, depression and anxiety, which negatively impacts the quality of life of men with prostate cancer. The central question of the proposed research is to determine if exercise will have a positive impact on the quality of life of men with prostate cancer undergoing ADT.

Hypothesis:


Condition Intervention
Prostate Cancer
 Behavioral: Exercise
Behavioral: Control

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • Cognitive-psychosocial functions [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • health-related quality of life [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: March 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise Behavioral: Exercise
Home-base walking program
No Intervention: Control Behavioral: Control
Usual care

  Eligibility

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

Inclusion Criteria:

  • men aged 50 or older
  • diagnosed with adenocarcinoma prostate cancer
  • will initiate and receive continuous ADT (LHRH or combination of LHRH and anti-androgen for at least 6 months

Exclusion Criteria:

  • severe cardiac disease (New York Heart Association class III or greater)
  • angina
  • severe osteoporosis
  • uncontrolled hypertension
  • orthostastic 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
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00856102

Locations
Canada, Manitoba
University of Manitoba
Winnipeg, Manitoba, Canada, R3E 0T6
Sponsors and Collaborators
University of Manitoba
Health Sciences Centre Foundation, 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,, University of Manitoba
ClinicalTrials.gov Identifier: NCT00856102     History of Changes
Other Study ID Numbers: H2008:318
Study First Received: March 3, 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
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013