An interventional study of Supervised and Home Based Exercise and Stretching Control Group in Prostate Cancer, Physical Activity and Side-effects, sponsored by Georgetown University. Completed at 1 site in United States. Open to male participants aged 40 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-02-15.
Sponsored by Georgetown University · Not applicable, Interventional, and Supportive care
This main purpose of this study is to examine the effects of an exercise intervention to counteract adverse side effects related to Androgen Deprivation Therapy (ADT) in prostate cancer patients. Specifically, a supervised and home-based exercise program will be used to assess its impact on clinical and behavioral variables related to ADT in prostate cancer patients.
This study will assess the feasibility of an exercise intervention to counteract adverse side effects related to ADT in prostate cancer (PCa) patients. Specifically, we will use an exercise intervention and assess its impact on bone mass density, Body Mass Index (BMI), hip/waist circumference levels, biomarkers (i.e., glucose, lipids), step count, grip strength, and health-related quality of life (HRQOL) using the Patient Reported Outcomes Measurement Information System (PROMIS®). In this 8-week two-arm randomized clinical trial, 40 PCa patients receiving ADT will be randomly assigned to an exercise (n=20) or a stretching control group (n=20) with a follow-up at 8-weeks.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 19 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Georgetown University is the lead sponsor of 286 studies on the registry; 42 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 20 (71%) have results posted.
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Exclusion Criteria:
8-weeks of supervised and home based exercise intervention, 3 times a week, 50-minutes a session for a total of 150/minutes a week
Behavioral: Supervised and Home Based Exercise
Informational booklet containing stretching exercises (20-minutes a day)
Behavioral: Stretching Control Group
Participants will come to our community based research office for up to 50 min/session, 3-days/week of supervised exercise for 8-weeks. The exercise intensity will be tailored between 60-80% of their VO2max, as determined during baseline testing and with a rating of perceived exertion (RPE) of 11-14 on the 20-point scale.
Participants randomized into the control group will be provided an informational booklet with stretching techniques and exercises and will be asked to stretch at least 20-minutes a day for the duration of the study.
Bone Mineral Density
BMD will be measured by a DXA scan
Time frame: 8-weeks
Physical Fitness
. The Bruce treadmill protocol will be used to examine VO2max using a ParvoMedics TrueOne 2400 metabolic cart
Time frame: 8-weeks
Muscle strength
Grip strength will be measured in a standardized way (three times in each arm) using a Jamar Dynamometer
Time frame: 8-weeks
Step Count
The Fit Bit reliably measures daily steps taken, distance walked, calories burned, and overall activity level.
Time frame: 8-weeks
Quality of Life (HRQOL)
The 10-item PROMIS® Global Health Scale will be used to assess key HRQOL domains including pain, fatigue, mental health, physical health, social health, and overall health
Time frame: 8-weeks
Hip/Waist Circumference
Anthropometric measures
Time frame: 8-weeks
Body Mass Index (BMI)
BMI will be measured according to height and weight
Time frame: 8-weeks
Glucose/Lipid levels
A fasting finger stick sample of blood (35 μl) will be assessed for immediate analysis of lipid panel (i.e., total cholesterol, HDL cholesterol, LDL cholesterol, VLDL cholesterol, triglycerides) and fasting glucose
Time frame: 8-weeks
This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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