Supervised Group Based Exercise for Men With Prostate Cancer on Androgen Deprivation Therapy
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|ClinicalTrials.gov Identifier: NCT02631681|
Recruitment Status : Completed
First Posted : December 16, 2015
Last Update Posted : August 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Prostatic Neoplasms Exercise Therapy Androgen Deprivation Therapy||Behavioral: Group based exercise||Not Applicable|
The aim of the project is to investigate the effects of patient education and exercise intervention implemented in daily clinical practice for men with prostate cancer on androgen deprivation therapy
- Functional capacity
- Quality of life
- Body composition
- Blood pressure
and to assess safety of progressive resistance training for participants with bone metastases.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Supervised Group Based Exercise for Men With Prostate Cancer on Androgen Deprivation Therapy|
|Study Start Date :||August 2014|
|Actual Primary Completion Date :||September 2017|
|Actual Study Completion Date :||September 2017|
Experimental: Men with prostate cancer on androgen deprivation therapy
Group based supervised combined aerobic and resistance training for 12 weeks.
Behavioral: Group based exercise
Supervised group based combined aerobic and resistance training for 12 weeks as part of our normal clinical practice.
- Change in 30second Chair-Stand test (30s-CST) [ Time Frame: Baseline, 12 and 24 weeks ]Test of functional capacity, measured as change
- Change in Graded Cycling Test with Talk Test (GCT-TT) [ Time Frame: Baseline, 12 and 24 weeks ]Test of functional capacity, measured as change
- change in QoL [ Time Frame: Baseline, 12 and 24 weeks ]European Organisation for Research and Treatment of Cancer (EORTC) cancer and prostate specific questionnaires: EORTC QLQC-30 version 3.0 and PR25
- change in Body composition [ Time Frame: Baseline, 12 and 24 weeks ]BMI, waist and hip circumference, waist-hip ratio.
- change in Bloodpressure [ Time Frame: Baseline, 12 and 24 weeks ]Systolic and diastolic bloodpressure
- Safety of exercise assessed by serious adverse events according to the FDA [ Time Frame: Study period baseline - 24 weeks ]
- Compliance assessed by attendance and continued exercise (yes/no) [ Time Frame: Baseline, 12 and 24 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02631681
|Herlev and Gentofte Hospital|
|Herlev, Please Select An Option Below, Denmark, 2100|
|Principal Investigator:||Peter B Østergren, MD||Herlev and Gentofte Hospital, Faculty of Health and Medical Sciences, Copenhagen University, Denmark|