Back to resultsSupervised Group Based Exercise for Men With Prostate Cancer on Androgen Deprivation Therapy
Primary Purpose
Prostatic Neoplasms, Exercise Therapy, Androgen Deprivation Therapy
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Group based exercise
Sponsored by
About this trial
This is an interventional treatment trial for Prostatic Neoplasms
Eligibility 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
Sites / Locations
- Herlev and Gentofte Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Men with prostate cancer on androgen deprivation therapy
Arm Description
Group based supervised combined aerobic and resistance training for 12 weeks.
Outcomes
Primary Outcome Measures
Change in 30second Chair-Stand test (30s-CST)
Test of functional capacity, measured as change
Change in Graded Cycling Test with Talk Test (GCT-TT)
Test of functional capacity, measured as change
Secondary Outcome Measures
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
change in Body composition
BMI, waist and hip circumference, waist-hip ratio.
change in Bloodpressure
Systolic and diastolic bloodpressure
Safety of exercise assessed by serious adverse events according to the FDA
Compliance assessed by attendance and continued exercise (yes/no)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02631681
Brief Title
Supervised Group Based Exercise for Men With Prostate Cancer on Androgen Deprivation Therapy
Official Title
Supervised Group Based Exercise for Men With Prostate Cancer on Androgen Deprivation Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Herlev Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms, Exercise Therapy, Androgen Deprivation Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Men with prostate cancer on androgen deprivation therapy
Arm Type
Experimental
Arm Description
Group based supervised combined aerobic and resistance training for 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Group based exercise
Intervention Description
Supervised group based combined aerobic and resistance training for 12 weeks as part of our normal clinical practice.
Primary Outcome Measure Information:
Title
Change in 30second Chair-Stand test (30s-CST)
Description
Test of functional capacity, measured as change
Time Frame
Baseline, 12 and 24 weeks
Title
Change in Graded Cycling Test with Talk Test (GCT-TT)
Description
Test of functional capacity, measured as change
Time Frame
Baseline, 12 and 24 weeks
Secondary Outcome Measure Information:
Title
change in QoL
Description
European Organisation for Research and Treatment of Cancer (EORTC) cancer and prostate specific questionnaires: EORTC QLQC-30 version 3.0 and PR25
Time Frame
Baseline, 12 and 24 weeks
Title
change in Body composition
Description
BMI, waist and hip circumference, waist-hip ratio.
Time Frame
Baseline, 12 and 24 weeks
Title
change in Bloodpressure
Description
Systolic and diastolic bloodpressure
Time Frame
Baseline, 12 and 24 weeks
Title
Safety of exercise assessed by serious adverse events according to the FDA
Time Frame
Study period baseline - 24 weeks
Title
Compliance assessed by attendance and continued exercise (yes/no)
Time Frame
Baseline, 12 and 24 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter B Østergren, MD
Organizational Affiliation
Herlev and Gentofte Hospital, Faculty of Health and Medical Sciences, Copenhagen University, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Herlev and Gentofte Hospital
City
Herlev
State/Province
Please Select An Option Below
ZIP/Postal Code
2100
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27357198
Citation
Ostergren P, Ragle AM, Jakobsen H, Klausen TW, Vinther A, Sonksen J. Group-based exercise in daily clinical practice to improve physical fitness in men with prostate cancer undergoing androgen deprivation therapy: study protocol. BMJ Open. 2016 Jun 29;6(6):e011460. doi: 10.1136/bmjopen-2016-011460.
Results Reference
derived
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Supervised Group Based Exercise for Men With Prostate Cancer on Androgen Deprivation Therapy
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