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| Sponsor: | Duke University |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Duke University |
| ClinicalTrials.gov Identifier: | NCT00873665 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Erectile Dysfunction |
Other: aerobic exercise Other: wait-list control |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Exercise Training, Erectile Dysfunction, and Prostate Cancer Study. |
| Estimated Enrollment: | 50 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
The test of the arm effect of incidence of ED will be made with the Wald chi-square test from the logistic regression model. A dichotomous variable indicating whether the patient received PDE-5 inhibitor therapy will be used as a covariate in the model. The arm effect will be summarized by giving arm-specific covariate-adjusted proportions and their 80% confidence intervals, and the p-value.
|
Other: aerobic exercise
To determine the effects of supervised aerobic exercise training versus usual care on incidence of ED among men undergoing radical prostatectomy for clinically localized prostate cancer.
Other Name: Erectile Dysfunction
|
|
2
For the analyses of arm differences in erectile dysfunction (IIEF) score, sexual functioning, urinary incontinence, and QOL, the primary endpoints will be the change across time in these continuous variables. Specifically, change across time for LTF patients will be imputed to be zero for all these analyses.
|
Other: wait-list control
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 phosphodiesterases type-5 (PDE-5) inhibitor therapy as well as therapy dose.
Other Name: Erectile Dysfunction
|
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:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Subjects must not have any of following absolute contraindications to exercise testing as recommended by the American Thoracic Society91:
Contacts and Locations| Contact: Lee W Jones, Ph.D. | 919-668-6791 | lee.w.jones@duke.edu |
| Contact: Michelle Schroder | 919-5301 | michelle.shroder@duke.edu |
| United States, North Carolina | |
| Duke University Medical Center | Recruiting |
| Durham, North Carolina, United States, 27710 | |
| Contact: Lee W Jones, Ph.D 919-668-6791 lee.w.jones@duke.edu | |
| Contact: Miranda West 919-681-5494 miranda.west@duke.edu | |
| Principal Investigator: Lee W Jones, Ph.D. | |
| Principal Investigator: | Lee W Jones, Ph.D. | Duke University |
More Information
| Responsible Party: | Lee Jones Ph.D., Duke University Medical Center |
| ClinicalTrials.gov Identifier: | NCT00873665 History of Changes |
| Other Study ID Numbers: | 00011329, CA133895-01 |
| Study First Received: | March 30, 2009 |
| Last Updated: | February 11, 2010 |
| Health Authority: | United States: Institutional Review Board |
|
Erectile Dysfunction Sexual Dysfunction, Physiological Genital Diseases, Male |
Sexual Dysfunctions, Psychological Sexual and Gender Disorders Mental Disorders |