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Sponsored by: |
Duke University |
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Information provided by: | Duke University |
ClinicalTrials.gov Identifier: | NCT00620932 |
The primary objective is to determine the feasibility and acceptability of a home-based endurance exercise program among men diagnosed with clinically localized prostate cancer.
Condition | Intervention |
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Prostatectomy |
Behavioral: Exercise |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Feasibility of Endurance Exercise Training on Cardiovascular Risk Factors Following Radical Prostatectomy Among Men With Localized Prostate Cancer; A Community-Based Intervention |
Estimated Enrollment: | 40 |
Study Start Date: | January 2008 |
Study Completion Date: | November 2008 |
Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Controll Group: No Intervention
These patients will continue with whatever routine exercise they already engage in.
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Behavioral: Exercise
Patients will be randomly assigned to groups and will either be given an exercise program individually tailored to them for them to participate in for 6 months or else be wait-listed for 6 months and remain on whatever exercise regimen they were already on.
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Exercise Arm: Experimental
These patients will participate in a controlled, supervised exercise program.
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Behavioral: Exercise
Patients will be randomly assigned to groups and will either be given an exercise program individually tailored to them for them to participate in for 6 months or else be wait-listed for 6 months and remain on whatever exercise regimen they were already on.
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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.
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 groups:
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.
OR
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, North Carolina | |
Duke University Medical Center Preston Robert Tisch Brain Tumor Center | |
Durham, North Carolina, United States, 27710 |
Principal Investigator: | Lee Jones, PHd | Duke University |
Responsible Party: | Duke University Medical Center ( Lee Jones, PhD ) |
Study ID Numbers: | Pro00002501 |
Study First Received: | February 12, 2008 |
Last Updated: | November 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00620932 History of Changes |
Health Authority: | United States: Institutional Review Board |
Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Neoplasms Neoplasms by Site Prostatic Diseases Genital Neoplasms, Male |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |