Erectile Dysfunction Clinical Trial
Official title:
Exercise Training, Erectile Dysfunction, and Prostate Cancer Study.
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.
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.
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Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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