Physical Activity Intervention in African American Men After Radical Prostatectomy

Not Applicable

Withdrawn

• Conditions: Prostate Cancer; Prostatectomy

• Registration Number: NCT02621684
• Lead Sponsor: Washington University School of Medicine

Brief Summary

The purpose of this pilot study is to evaluate the feasibility of recruiting African American prostate cancer survivors to a 12 week physical activity intervention study of three arms (aerobics, resistance training, and usual care) through physician referral and community advertisement strategies. In addition, the investigators will investigate the acceptance rate of the intervention and gather preliminary results on the effect of exercise on African American men's urinary and sexual functions. These data can then be used to refine the intervention and its implementation model, and to inform the submission of a larger grant to the National Institutes of Health.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2015-11-25
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Study First Submitted QC: 2015-12-01
• Study First Posted: 2015-12-03
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-28
• Last Update Posted: 2016-01-29

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

• Speaks English
• African American
• Radical prostatectomy for treatment of prostate cancer within the past 12 months
• Cleared by physician to safely participate in a physical exercise program

Exclusion Criteria

• Does not speak English
• Non-African American
• Previously undergone radiation treatment to the pelvis
• Previously undergone major pelvic surgery
• Known urethral stricture, colostomy, or inability to urinate requiring chronic urinary catheter

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Intervention effectiveness as measured by change in accelerometer measured physical activity	Completion of study (approximately 3.5 years)
Intervention effectiveness as measured by change in self-reported urinary/sexual function as measured by Expanded Prostate Cancer Index Composite (EPIC)	Completion of study (approximately 3.5 years)	-Intervention effectiveness will be compared between the three arms by comparing the change in self-reported urinary and sexual function. Mixed effects regression will be used to account for the longitudinal design.
Recruitment rate comparisons between physician referral and community advertisement	Completion of study (approximately 3.5 years)
Attrition rate in each arm	Completion of study (approximately 3.5 years)	* Evaluate percentage of finished duration of walking in each session and percentage of total finished session in the aerobic exercise arm.; * Evaluate the percentage of attended sessions in the resistance training arm