Erectile Dysfunction Study

NCT00873665 | Completed

• 2 other identifiers: Pro00011329CA133895-01
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (2)

• To determine the effects of aerobic exercise training versus wait-list control on changes in patient symptoms and the number of men receiving phosphodiesterases type-5 (PDE-5) inhibitor therapy as well as therapy dose.

  12 months

• 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.

Study Arms (2)

Aerobic exercise

EXPERIMENTAL

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. 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

Wait-list control

OTHER

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. 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

Interventions

aerobic exercise OTHER

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.

Also known as: Erectile Dysfunction

Aerobic exercise

wait-list control OTHER

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.

Also known as: Erectile Dysfunction

Wait-list control

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Legal age (\>18 years old)
• An interval of at least 4-6 weeks between prior radical prostatectomy and study enrollment. Radical prostatectomy-induced ED is an immediate and progressive disorder as such interventions shortly following surgery may be the most effective at attenuating this disorder. It is expected that men who have undergone radical prostatectomy will be fully recovered at 4-6 weeks post surgery and will be receptive to an exercise intervention study at this time (capitalizing on the teachable moment). Additionally, the PI has demonstrated that maximal cardiopulmonary exercise testing is a safe, feasible, and acceptable assessment procedure 7±3 days post-craniotomy among 20 primary high grade primary brain tumor patients and 30±5 days post-pneumonectomy or lobectomy among 20 operable non-small cell lung cancer patients,
• Karnofsky performance status of at least 70% at study entry,
• Estimated life expectancy of ≥6 months,
• Ability to read and understand English,
• Primary attending urologist approval (Drs. Donatucci and Moul),
• Signed informed consent prior to initiation of study-related procedures,
• Willingness to be randomized,
• Sedentary (i.e., men not performing regular exercise on at least 5 days a week, for at least 30 minutes each session, at a moderate or vigorous intensity for the past month). This definition is consistent with the national exercise recommendations guidelines and will ensure that only men not currently engaging in regular exercise (i.e., those who are the most likely to benefit) are recruited,
• Postoperative erectile function (score ≤21 on the International Index of Erectile Function (IIEF) multidimensional questionnaire90). To avoid potential ceiling effects (i.e., testing of the intervention among men with only good erectile function), only men with an IIEF score ≤21, which indicates ED, will be recruited.

You may not qualify if:

• Presence of a concurrent, actively treated other malignancy or history of other malignancy treated within the past 3 years (other than non-melanoma skin cancer),
• Presence of metastatic disease,
• Scheduled to receive any form of adjuvant cancer therapy (i.e., radiation, chemotherapy, androgen deprivation therapy),
• Subjects must not have any of following absolute contraindications to exercise testing as recommended by the American Thoracic Society91:
• acute myocardial infarction (3-5 days)
• unstable angina
• uncontrolled arrhythmias causing symptoms or hemodynamic compromise
• syncope
• acute endocarditis
• acute myocarditis or pericarditis
• uncontrolled heart failure
• acute pulmonary embolus or pulmonary infarction
• thrombosis of lower extremities
• suspected dissecting aneurysm
• uncontrolled asthma

Sponsors & Collaborators

• Duke University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

Exercise

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Lee W Jones, Ph.D.

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2009
• First Posted: April 1, 2009
• Study Start: December 1, 2008
• Primary Completion: December 1, 2012
• Study Completion: March 1, 2013
• Last Updated: October 28, 2013

Record last verified: 2013-07

Locations

US (1)