The Physical Exercise and Prostate Cancer Study (PEPC)
The purpose of this study is to determine the effectiveness of a four months strength training program on physical and psychological health in patients with prostate cancer during androgen deprivation therapy. It is hypothesized a beneficial effect of the intervention on physical and psychological health in patients with prostate cancer treated with androgen deprivation.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Physical Exercise for Patients With Prostate Cancer During Androgen Deprivation Therapy - A Randomized Trial|
- lean body mass [ Time Frame: before ADT, before and after the intervention ] [ Designated as safety issue: No ]
- bone mineral density, fat mass, body mass index, serological outcomes (including lipids, hormones and CRP), physical functioning, psycho-social functioning and muscle cellular outcomes (including muscle fiber size and function) [ Time Frame: before ADT, before and after the intervention ] [ Designated as safety issue: No ]
|Study Start Date:||November 2008|
|Study Completion Date:||May 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Experimental: Strength training group
A four months strength training program during androgen deprivation therapy for prostate cancer patietns.
Behavioral: Strength training group
After 5-10 months on androgen deprivation therapy the patients in the intervention group go through a four months strength training intervention. The patients will perform three strength-training sessions per week, two under supervision of a sport instructor. Each session will consists of one-three sets of nine strength-training exercises, performed at an intensity of 6 or 10 repetitions of maximum (6-10 RM).
Other Name: Exercise, Physical activity
No Intervention: Control group
Patients in the control group are not discouraged from performing normal activities. They are however asked not to start a strength training program or increase their activity level in the same period as the experimental group is performing their strength training program. We will offer the control group a modified strength training program after the post-intervention assessment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00658229
|Rikshospitalet- Radiumhospitalet HF|
|Montebello, Oslo, Norway, 0310|
|Principal Investigator:||Lene Thorsen, PhD||Oslo University Hospital|