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Physical Activity Intervention in African American Men After Radical Prostatectomy

A Pilot Study of Physical Activity Intervention in African American Men After Radical Prostatectomy

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02621684
Enrollment
0
Registered
2015-12-03
Start date
2014-11-30
Completion date
2015-12-31
Last updated
2016-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer, Prostatectomy

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.

Interventions

OTHERCommunity Health Activities Model Program for Seniors (CHAMPS)

* Physical activity questionnaire for older adults * Asks about activities in the past 4 weeks * 41 questions and asks to notate how long the activity took

OTHERLifetime Total Physical Activity Questionnaire

* Questions about leisure time (27) and household activities (5) * Mark if participated in the activity during the past year, ages 51-65, 35-50, 23-34, and onset of puberty through 21 years

OTHERExpanded Prostate Cancer Index Composite (EPIC)

* Measures urinary and sexual function before and after prostate cancer treatment * 7 questions about urinary function * 9 questions about sexual function

OTHERInternational Physical Activity Prevalence Study Environmental Module

-The 17-item Physical Activity Neighborhood Environment Scale can be used to assess the environmental factors for walking and bicycling in various neighborhoods.

OTHERGodin Leisure-Time Exercise Questionnaire (GLTEQ)

-4 item query of usual leisure time exercise habits

OTHERQuestionnaire regarding behavior/lifestyle changes since diagnosis
OTHER12 week Walking Program
OTHER12 week Resistance Training Program

Sponsors

Washington University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Recruitment rate comparisons between physician referral and community advertisementCompletion of study (approximately 3.5 years)
Attrition rate in each armCompletion 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
Intervention effectiveness as measured by change in accelerometer measured physical activityCompletion 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026