Exercise and Cognitive-psychosocial Functions in Men With Prostate Cancer Receiving Androgen Depletion Therapy
Efficacy of Exercise in Promotion Cognitive-psychosocial Functions in Men With Prostate Cancer Receiving Androgen Depletion Therapy
1 other identifier
interventional
30
1 country
1
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:
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable prostate-cancer
Started Mar 2009
Shorter than P25 for not_applicable prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 3, 2009
CompletedFirst Posted
Study publicly available on registry
March 5, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedFebruary 1, 2011
January 1, 2011
1.8 years
March 3, 2009
January 31, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Cognitive-psychosocial functions
3 and 6 months
Secondary Outcomes (1)
health-related quality of life
3 and 6 months
Study Arms (2)
Exercise
EXPERIMENTALControl
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Manitoba
Winnipeg, Manitoba, R3E 0T6, Canada
Related Publications (1)
Lee CE, Kilgour A, Lau YK. Efficacy of walking exercise in promoting cognitive-psychosocial functions in men with prostate cancer receiving androgen deprivation therapy. BMC Cancer. 2012 Jul 30;12:324. doi: 10.1186/1471-2407-12-324.
PMID: 22846379DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
March 3, 2009
First Posted
March 5, 2009
Study Start
March 1, 2009
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
February 1, 2011
Record last verified: 2011-01