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Completed

NCT Number: NCT00856102

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

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:

Completed

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

50 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Manitoba

Winnipeg, Manitoba, R3E 0T6, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Behavioral

Home-base walking program

Control

Behavioral

Usual care

Primary outcomes

  1. Cognitive-psychosocial functions

    Time frame: 3 and 6 months

Secondary outcomes

  1. health-related quality of life

    Time frame: 3 and 6 months

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Collaborators

  • Health Sciences Centre Foundation, Manitoba

Registry information

Official study title

Efficacy of Exercise in Promotion Cognitive-psychosocial Functions in Men With Prostate Cancer Receiving Androgen Depletion Therapy

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Mar 5, 2009
Registry last updated
Feb 1, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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