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

U

University of Manitoba

Status

Completed

Conditions

Prostate Cancer

Treatments

Behavioral: Control
Behavioral: Exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT00856102
H2008:318

Details and patient eligibility

About

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:

Enrollment

30 estimated patients

Sex

Male

Ages

50+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

30 participants in 2 patient groups

Exercise
Experimental group
Treatment:
Behavioral: Exercise
Control
No Intervention group
Treatment:
Behavioral: Control

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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