search
Back to results

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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Exercise
Control
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Manitoba

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise

Control

Arm Description

Outcomes

Primary Outcome Measures

Cognitive-psychosocial functions

Secondary Outcome Measures

health-related quality of life

Full Information

First Posted
March 3, 2009
Last Updated
January 31, 2011
Sponsor
University of Manitoba
Collaborators
Health Sciences Centre Foundation, Manitoba
search

1. Study Identification

Unique Protocol Identification Number
NCT00856102
Brief Title
Exercise and Cognitive-psychosocial Functions in Men With Prostate Cancer Receiving Androgen Depletion Therapy
Official Title
Efficacy of Exercise in Promotion Cognitive-psychosocial Functions in Men With Prostate Cancer Receiving Androgen Depletion Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Manitoba
Collaborators
Health Sciences Centre Foundation, Manitoba

4. Oversight

Data Monitoring Committee
Yes

5. 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:

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
Home-base walking program
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
Usual care
Primary Outcome Measure Information:
Title
Cognitive-psychosocial functions
Time Frame
3 and 6 months
Secondary Outcome Measure Information:
Title
health-related quality of life
Time Frame
3 and 6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0T6
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
22846379
Citation
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs