An Exercise Intervention to Mitigate Side-Effects Related to Androgen Deprivation Therapy Among Prostate Cancer Survivors.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Georgetown University
- Enrollment
- 19
- Locations
- 1
- Primary Endpoint
- Bone Mineral Density
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 40 Years to 70 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •(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
Exclusion Criteria
- •(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.
Arms & Interventions
Exercise Group
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
Intervention: Supervised and Home Based Exercise (Behavioral)
Stretching Control group
Informational booklet containing stretching exercises (20-minutes a day)
Intervention: Stretching Control Group (Behavioral)
Outcomes
Primary Outcomes
Bone Mineral Density
Time Frame: 8-weeks
BMD will be measured by a DXA scan
Secondary Outcomes
- Physical Fitness(8-weeks)
- Muscle strength(8-weeks)
- Step Count(8-weeks)
- Quality of Life (HRQOL)(8-weeks)
- Hip/Waist Circumference(8-weeks)
- Body Mass Index (BMI)(8-weeks)
- Glucose/Lipid levels(8-weeks)