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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00856102

Enrollment

Registered

2009-03-05

Start date

2009-03-31

Completion date

2010-12-31

Last updated

2011-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

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:

Interventions

BEHAVIORALExercise

Home-base walking program

BEHAVIORALControl

Usual care

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

50 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Cognitive-psychosocial functions	3 and 6 months

Secondary

Measure	Time frame
health-related quality of life	3 and 6 months

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026