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

August 28, 2019 updated by: Peter Busch Østergren, Herlev Hospital
Exercise intervention for men with prostate cancer on androgen deprivation therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Please Select An Option Below
      • Herlev, Please Select An Option Below, Denmark, 2100
        • Herlev and Gentofte Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional 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
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, 12 and 24 weeks
change in Body composition
Time Frame: Baseline, 12 and 24 weeks
BMI, waist and hip circumference, waist-hip ratio.
Baseline, 12 and 24 weeks
change in Bloodpressure
Time Frame: Baseline, 12 and 24 weeks
Systolic and diastolic bloodpressure
Baseline, 12 and 24 weeks
Safety of exercise assessed by serious adverse events according to the FDA
Time Frame: Study period baseline - 24 weeks
Study period baseline - 24 weeks
Compliance assessed by attendance and continued exercise (yes/no)
Time Frame: Baseline, 12 and 24 weeks
Baseline, 12 and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Herlev Hospital

Investigators

  • Principal Investigator: Peter B Østergren, MD, Herlev and Gentofte Hospital, Faculty of Health and Medical Sciences, Copenhagen University, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

December 10, 2015

First Submitted That Met QC Criteria

December 11, 2015

First Posted (Estimate)

December 16, 2015

Study Record Updates

Last Update Posted (Actual)

August 30, 2019

Last Update Submitted That Met QC Criteria

August 28, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ProstEx

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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