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document
A phase III clinical trial of exercise modalities on treatment side-effects in men receiving therapy for prostate cancer . BACKGROUND Androgen deprivation therapy ( ADT ) is accompanied by a number of adverse side effects including reduced bone mass and increased risk for fracture , reduced lean mass and muscle strength , mood disturbance and increased fat mass compromising physical functioning , independence , and quality of life . The purpose of this investigation is to examine the effects of long term exercise on reversing musculoskeletal-related side effects , and cardiovascular and diabetes risk factors in men receiving androgen deprivation for their prostate cancer . Specifically , we aim to investigate the effects of a 12-month exercise program designed to load the musculoskeletal system and reduce cardiovascular and diabetes disease progression on the following primary endpoints : 1 ) bone mineral density ; 2 ) cardiorespiratory function and maximal oxygen capacity ; 3 ) body composition ( lean mass and fat mass ) ; 4 ) blood pressure and cardiovascular function ; 5 ) lipids and glycemic control ; and 6 ) quality of life and psychological distress . METHODS/DESIGN Multi-site randomized controlled trial of 195 men ( 65 subjects per arm ) undergoing treatment for prostate cancer involving ADT in the cities of Perth and Brisbane in Australia . Participants will be randomized to ( 1 ) resistance/impact loading exercise , ( 2 ) resistance/cardiovascular exercise groups and ( 3 ) usual care/delayed exercise . Participants will then undergo progressive training for 12 months . Measurements for primary and secondary endpoints will take place at baseline , 6 and 12 months ( end of the intervention ) . DISCUSSION The principal outcome of this project will be the determination of the strength of effect of exercise on the well established musculoskeletal , cardiovascular and insulin metabolism side effects of androgen deprivation in prostate cancer patients . As this project is much longer term than previous investigations in the area of exercise and cancer , we will gain knowledge as to the continuing effects of exercise in this patient population specifically targeting bone density , cardiovascular function , lean and fat mass , physical function and falls risk as primary study endpoints . In terms of advancement of prostate cancer care , we expect dissemination of the knowledge gained from this project to reduce fracture risk , improve physical and functional ability , quality of life and ultimately survival rate in this population . CLINICAL TRIAL REGISTRY A Phase III clinical trial of exercise modalities on treatment side-effects in men receiving therapy for prostate cancer ; ACTRN12609000200280 .
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Intervention_Physical
exercise
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Intervention_Pharmacological
Androgen deprivation therapy ( ADT )
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Intervention_Physical
exercise
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Intervention_Pharmacological
androgen deprivation
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Intervention_Physical
exercise program
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Intervention_Pharmacological
ADT
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Intervention_Physical
resistance/impact loading exercise , ( 2 ) resistance/cardiovascular exercise groups and ( 3 ) usual care/delayed exercise .
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Intervention_Physical
progressive training
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Intervention_Physical
exercise
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Outcome_Adverse-effects
musculoskeletal-related side effects
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Outcome_Physical
cardiovascular and diabetes risk factors
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Outcome_Physical
bone mineral density ; 2 ) cardiorespiratory function and maximal oxygen capacity ; 3 ) body composition ( lean mass and fat mass ) ; 4 ) blood pressure and cardiovascular function ; 5 ) lipids and glycemic control ; and
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Outcome_Other
quality of life and psychological distress
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Outcome_Adverse-effects
side effects
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Outcome_Physical
bone density , cardiovascular function , lean and fat mass , physical function and falls risk
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Outcome_Physical
fracture risk , improve physical and functional ability
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Outcome_Other
quality of life
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Outcome_Mortality
ultimately survival rate
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Participant_Sex
men
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Participant_Condition
prostate cancer
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Participant_Sex
men
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Participant_Condition
androgen deprivation
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Participant_Sample-size
195
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Participant_Sex
men
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Participant_Condition
prostate cancer involving ADT