Supervised Group Based Exercise for Men With Prostate Cancer on Androgen Deprivation Therapy
1 other identifier
interventional
200
1 country
1
Brief Summary
Exercise intervention for men with prostate cancer on androgen deprivation therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 10, 2015
CompletedFirst Posted
Study publicly available on registry
December 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedAugust 30, 2019
August 1, 2019
3.1 years
December 10, 2015
August 28, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (5)
change in QoL
Baseline, 12 and 24 weeks
change in Body composition
Baseline, 12 and 24 weeks
change in 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
Study Arms (1)
Men with prostate cancer on androgen deprivation therapy
EXPERIMENTALGroup based supervised combined aerobic and resistance training for 12 weeks.
Interventions
Supervised group based combined aerobic and resistance training for 12 weeks as part of our normal clinical practice.
Eligibility Criteria
You may qualify if:
- Patients with a prostate cancer diagnosis on androgen deprivation therapy
You may not qualify if:
- Opioid demanding treatment for skeletal pain
- Eastern Cooperative Oncology Group performance status \> 2
- Inability to perform floor and machine exercises independently
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Herlev Hospitallead
Study Sites (1)
Herlev and Gentofte Hospital
Herlev, Please Select An Option Below, 2100, Denmark
Related Publications (1)
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.
PMID: 27357198DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter B Østergren, MD
Herlev and Gentofte Hospital, Faculty of Health and Medical Sciences, Copenhagen University, Denmark
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D.
Study Record Dates
First Submitted
December 10, 2015
First Posted
December 16, 2015
Study Start
August 1, 2014
Primary Completion
September 1, 2017
Study Completion
September 1, 2017
Last Updated
August 30, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share