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

This study is not yet open for participant recruitment.

Verified by University of Manitoba, February 2009

First Received: March 3, 2009 No Changes Posted

Sponsors and Collaborators:	University of Manitoba Health Sciences Centre Foundation, Manitoba
Information provided by:	University of Manitoba
ClinicalTrials.gov Identifier:	NCT00856102

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:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment
Official Title:	Efficacy of Exercise in Promotion Cognitive-Psychosocial Functions in Men With Prostate Cancer Receiving Androgen Depletion Therapy

Resource links provided by NLM:

MedlinePlus related topics: Cancer Exercise and Physical Fitness Prostate Cancer

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:	60
Study Start Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Exercise: Experimental	Behavioral: Exercise Home-base walking program
Control: No Intervention	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

Contacts

Contact: C. Ellen Lee, PhD, PT

787-1899

celee@cc.umanitoba.ca

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

Responsible Party:	University of Manitoba ( C. Ellen Lee, )
Study ID Numbers:	H2008:318
Study First Received:	March 3, 2009
Last Updated:	March 3, 2009
ClinicalTrials.gov Identifier:	NCT00856102 History of Changes
Health Authority:	Canada: Ethics Review Committee

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms

Genital Diseases, Male
Prostatic Neoplasms
Androgens

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on September 10, 2009