Supervised Group Based Exercise for Men With Prostate Cancer on Androgen Deprivation Therapy

Study Overview
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Brief Summary
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Exercise intervention for men with prostate cancer on androgen deprivation therapy.

Detailed Description
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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.

Official Title
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Supervised Group Based Exercise for Men With Prostate Cancer on Androgen Deprivation Therapy

Conditions
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Prostatic Neoplasms, Exercise Therapy, Androgen Deprivation Therapy

Intervention / Treatment
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* Behavioral: Group based exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a prostate cancer diagnosis on androgen deprivation therapy Exclusion Criteria: Opioid demanding treatment for skeletal pain Eastern Cooperative Oncology Group performance status > 2 Inability to perform floor and machine exercises independently

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Men with prostate cancer on androgen deprivation therapy<br>Group based supervised combined aerobic and resistance training for 12 weeks. | Behavioral: Group based exercise<br>* Supervised group based combined aerobic and resistance training for 12 weeks as part of our normal clinical practice.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 30second Chair-Stand test (30s-CST) | Test of functional capacity, measured as change | Baseline, 12 and 24 weeks | 
| Change in Graded Cycling Test with Talk Test (GCT-TT) | Test of functional capacity, measured as change | Baseline, 12 and 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in QoL | European Organisation for Research and Treatment of Cancer (EORTC) cancer and prostate specific questionnaires: EORTC QLQC-30 version 3.0 and PR25 | Baseline, 12 and 24 weeks | 
| change in Body composition | BMI, waist and hip circumference, waist-hip ratio. | Baseline, 12 and 24 weeks | 
| change in Bloodpressure | Systolic and diastolic bloodpressure | Baseline, 12 and 24 weeks | 
| Safety of exercise assessed by serious adverse events according to the FDA |  | Study period baseline - 24 weeks | 
| Compliance assessed by attendance and continued exercise (yes/no) |  | Baseline, 12 and 24 weeks |