Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02631681
Recruitment Status : Completed
First Posted : December 16, 2015
Last Update Posted : August 30, 2019
Sponsor:
Information provided by (Responsible Party):
Peter Busch Østergren, Herlev Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Exercise intervention for men with prostate cancer on androgen deprivation therapy.

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Exercise Therapy Androgen Deprivation Therapy Behavioral: Group based exercise Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change in 30second Chair-Stand test (30s-CST) [ Time Frame: Baseline, 12 and 24 weeks ]
    Test of functional capacity, measured as change

  2. Change in Graded Cycling Test with Talk Test (GCT-TT) [ Time Frame: Baseline, 12 and 24 weeks ]
    Test of functional capacity, measured as change


Secondary Outcome Measures :
  1. 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

  2. change in Body composition [ Time Frame: Baseline, 12 and 24 weeks ]
    BMI, waist and hip circumference, waist-hip ratio.

  3. change in Bloodpressure [ Time Frame: Baseline, 12 and 24 weeks ]
    Systolic and diastolic bloodpressure

  4. Safety of exercise assessed by serious adverse events according to the FDA [ Time Frame: Study period baseline - 24 weeks ]
  5. Compliance assessed by attendance and continued exercise (yes/no) [ Time Frame: Baseline, 12 and 24 weeks ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Locations
Layout table for location information
Denmark
Herlev and Gentofte Hospital
Herlev, Please Select An Option Below, Denmark, 2100
Sponsors and Collaborators
Herlev Hospital
Investigators
Layout table for investigator information
Principal Investigator: Peter B Østergren, MD Herlev and Gentofte Hospital, Faculty of Health and Medical Sciences, Copenhagen University, Denmark
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Peter Busch Østergren, M.D., Herlev Hospital
ClinicalTrials.gov Identifier: NCT02631681     History of Changes
Other Study ID Numbers: ProstEx
First Posted: December 16, 2015    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
 Prostatic Diseases
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs