Feasibility of Endurance Exercise Training on Cardiovascular Risk Factors Following Radical Prostatectomy Among Men With Localized Prostate Cancer; A Community-Based Intervention
Approximately 40 people will take part in this study and all of these people will take part
at Duke University Medical Center.
Participation in this study involves the following.
- We will ask you to perform a cardiopulmonary exercise test (walking stress test) to
determine if you have any undiagnosed cardiovascular health problems that may limit
your ability to participate in an exercise training program. This test will take place
at the Duke Center for Living on Duke University Campus.
- Complete a body composition assessment. This test is designed to determine your body
fat and lean body tissue (muscle mass) percentage and will consist of you sitting
quietly in a chamber with appropriate medical supervision. This test also will take
place at the Duke Center for Living on Duke University Campus.
- Complete two questionnaires one at the beginning and one at the end that asks about how
you are feeling and about your physical activity levels. The questionnaire takes about
- Provide two blood samples one at the beginning and one at the end to measure levels of
cardiovascular disease risk factors (cholesterol levels, c-reactive protein and insulin
levels) in your blood that may be influenced by exercise. Blood collection will be
drawn by medical staff at Duke University. The amount of blood drawn is approximately 2
- We will also collect information on how much treatment you receive as well as how many
and what type of side-effects you have from your medical treatment. This information
will be obtained from your medical chart following the completion of your treatment.
Following the successful completion of all initial tests and procedures (as described
above), you will be randomly assigned (like flipping a coin) to one of the following two
1. Exercise Training Group: You will be given a customized training program aimed at
increasing cardiorespiratory fitness. You will be asked to exercise 3 to 5 times per
week. All sessions will include a 5 minute warm-up and 5 minute cool-down at the
beginning and end of each session totaling 30-45 minutes per session. You will also
receive a heart rate monitor to record each exercise session to monitor adherence and
compliance. You will receive telephone calls every two weeks to provide encouragement,
outline goals, and provide feedback on study progress.
2. Wait-List Control Group: You will be asked to maintain your usual exercise levels
during the 6 month study period. You will receive telephone calls to report your levels
of exercise during the study. After study completion you will receive a heart rate
monitor and an individualized exercise prescription based on your cardiorespiratory
fitness test at the end of the study period (6 months).
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Cardiorespiratory Fitness will be determined using a incremental treadmill test with 12-lead ECG monitoring.
Lee Jones, PHd
United States: Institutional Review Board
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