An Exercise Intervention for Prostate Cancer Patients Receiving Androgen Deprivation Therapy
- Conditions
- Side-effectsProstate CancerPhysical Activity
- Interventions
- Behavioral: Stretching Control GroupBehavioral: Supervised and Home Based Exercise
- Registration Number
- NCT02248350
- Lead Sponsor
- Georgetown University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 19
- (1) Caucasian or African-American/Black men; (2) histologically confirmed non-metastatic PCa; (3) receiving ADT treatment for 9-months or less upon recruitment (and continue to receive treatment during the duration of the study); (4) 40 to 75 years old; (5) sedentary defined as <60 minutes of recreation or work requiring modest PA/week; (6) ability to perform the level of physical activity assessed by the Physical Activity Readiness Questionnaire (PAR-Q); (6) has access to a smartphone or computer with internet capabilities
- (1) severe cardiac disease; (2) recent myocardial infarction; (3) treated for any other cancer; (4) any physical, psychological illness, and/or medical problems that restricted them from exercise; (5) and not willing or able to follow procedures specified by the study and/or instructions of the researcher.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Stretching Control group Stretching Control Group Informational booklet containing stretching exercises (20-minutes a day) Exercise Group Supervised and Home Based Exercise 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
- Primary Outcome Measures
Name Time Method Bone Mineral Density 8-weeks BMD will be measured by a DXA scan
- Secondary Outcome Measures
Name Time Method Physical Fitness 8-weeks . The Bruce treadmill protocol will be used to examine VO2max using a ParvoMedics TrueOne 2400 metabolic cart
Muscle strength 8-weeks Grip strength will be measured in a standardized way (three times in each arm) using a Jamar Dynamometer
Step Count 8-weeks The Fit Bit reliably measures daily steps taken, distance walked, calories burned, and overall activity level.
Quality of Life (HRQOL) 8-weeks 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
Hip/Waist Circumference 8-weeks Anthropometric measures
Body Mass Index (BMI) 8-weeks BMI will be measured according to height and weight
Glucose/Lipid levels 8-weeks 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
Trial Locations
- Locations (1)
Office of Minority Health and Health Disparities Research
🇺🇸Washington, District of Columbia, United States