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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00856102
Recruitment Status : Completed
First Posted : March 5, 2009
Last Update Posted : February 1, 2011
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:

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 or disease Intervention/treatment
Prostate Cancer Behavioral: Exercise Behavioral: Control

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Exercise in Promotion Cognitive-psychosocial Functions in Men With Prostate Cancer Receiving Androgen Depletion Therapy
Study Start Date : March 2009
Primary Completion Date : December 2010
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Exercise Behavioral: Exercise
Home-base walking program
No Intervention: Control Behavioral: Control
Usual care


Outcome Measures

Primary Outcome Measures :
  1. Cognitive-psychosocial functions [ Time Frame: 3 and 6 months ]

Secondary Outcome Measures :
  1. health-related quality of life [ Time Frame: 3 and 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: March 5, 2009    Key Record Dates
Last Update Posted: February 1, 2011
Last Verified: January 2011

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