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Clinical Trial Summary

The investigators propose a single-site, prospective randomized trial to determine the effects of aerobic exercise training on ED among 50 sedentary men undergoing radical prostatectomy for clinically localized prostate cancer.


Clinical Trial Description

We propose a single-site, prospective randomized trial to determine the effects of aerobic exercise training on ED among 50 sedentary men undergoing radical prostatectomy for clinically localized prostate cancer. This project has three specific aims:

- Specific Aim #1: To determine the effects of aerobic exercise training versus wait-list control on incidence of ED among sedentary men undergoing radical prostatectomy for clinically localized prostate cancer.

- Hypothesis #1: Aerobic exercise training will be associated with a significantly lower incidence of ED compared with usual care among sedentary men undergoing radical prostatectomy for clinically localized prostate cancer.

- Specific Aim #2: To determine the effects of aerobic exercise training versus wait-list control on changes in patient symptoms (i.e., erectile function score, sexual functioning, urinary incontinence, and QOL) and the number of men receiving phosphodiesterase type-5 (PDE-5) inhibitor therapy as well as therapy dose.

- Hypothesis #2: Aerobic exercise training will improve patient symptoms and reduce the number of men requiring PDE-5 inhibitor therapy.

- Specific Aim #3: To determine the effects of aerobic exercise training versus wait-list control on changes in postulated biologic mechanisms that may underlie the relationship between exercise training and ED [i.e., CVD risk factors (cardiorespiratory fitness, lipid profile, blood pressure, c-reactive protein, body composition), cardiac function, and penile and brachial artery endothelial function].

- Hypothesis #3: Aerobic exercise training will be associated with favorable changes in postulated candidate mechanisms. ;


Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00873665
Study type Interventional
Source Duke University
Contact
Status Completed
Phase N/A
Start date December 2008
Completion date March 2013

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