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

NCT ID: NCT00856102

Last Updated: 2011-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2010-12-31

Brief Summary

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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:

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Exercise

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

Home-base walking program

Control

Group Type NO_INTERVENTION

Control

Intervention Type BEHAVIORAL

Usual care

Interventions

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Exercise

Home-base walking program

Intervention Type BEHAVIORAL

Control

Usual care

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Health Sciences Centre Foundation, Manitoba

OTHER

Sponsor Role collaborator

University of Manitoba

OTHER

Sponsor Role lead

Responsible Party

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University of Manitoba

Locations

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University of Manitoba

Winnipeg, Manitoba, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 22846379 (View on PubMed)

Other Identifiers

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H2008:318

Identifier Type: -

Identifier Source: org_study_id

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