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

Not Applicable

Completed

• Conditions: Androgen Deprivation Therapy; Exercise Therapy; Prostatic Neoplasms
• Interventions: Behavioral: Group based exercise

• Registration Number: NCT02631681
• Lead Sponsor: Herlev Hospital

Brief Summary

Exercise intervention for men with prostate cancer on androgen deprivation therapy.

Detailed Description

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 Timeline

• Study Start: 2014-08
• Study First Submitted: 2015-12-10
• Study First Submitted QC: 2015-12-11
• Study First Posted: 2015-12-16
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-28
• Last Update Posted: 2019-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Men with prostate cancer on androgen deprivation therapy	Group based exercise	Group based supervised combined aerobic and resistance training for 12 weeks.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
change in QoL	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	Baseline, 12 and 24 weeks	BMI, waist and hip circumference, waist-hip ratio.
change in Bloodpressure	Baseline, 12 and 24 weeks	Systolic and diastolic bloodpressure
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

Trial Locations

Locations (1)

Herlev and Gentofte Hospital; 🇩🇰 Herlev, Please Select An Option Below, Denmark