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Physical Activity Intervention in African American Men After Radical Prostatectomy

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The Washington University

Status

Withdrawn

Conditions

Prostatectomy
Prostate Cancer

Treatments

Other: Expanded Prostate Cancer Index Composite (EPIC)
Other: 12 week Resistance Training Program
Other: Lifetime Total Physical Activity Questionnaire
Other: 12 week Walking Program
Other: Questionnaire regarding behavior/lifestyle changes since diagnosis
Other: Community Health Activities Model Program for Seniors (CHAMPS)
Other: Godin Leisure-Time Exercise Questionnaire (GLTEQ)
Other: International Physical Activity Prevalence Study Environmental Module

Study type

Interventional

Funder types

Other

Identifiers

NCT02621684
201410072

Details and patient eligibility

About

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.

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 3 patient groups

Arm 1: Aerobics
Experimental group
Description:
* Complete baseline questionnaires either online or on paper * Questionnaires will also be completed at 6 weeks, 12 weeks, and 16 weeks after baseline * Participants will be asked to wear an accelerometer for 7 days at baseline, 12 weeks, and 16 weeks. * Receive printed materials from the American Cancer Society about cancer management and standard physical activity recommendations. * Require physical evaluation and orientation to the WellAware gym * 12 week walking program at the WellAware Center * required to check in with gym staff to check attendance * advised to walk at own pace for 3 days per week * 15 minutes per day for the first 2 weeks * 30 minutes per day for the next 2 weeks * 50 minutes or more for remaining weeks
Treatment:
Other: Godin Leisure-Time Exercise Questionnaire (GLTEQ)
Other: 12 week Walking Program
Other: Questionnaire regarding behavior/lifestyle changes since diagnosis
Other: International Physical Activity Prevalence Study Environmental Module
Other: Community Health Activities Model Program for Seniors (CHAMPS)
Other: Lifetime Total Physical Activity Questionnaire
Other: Expanded Prostate Cancer Index Composite (EPIC)
Arm 2: Resistance training
Experimental group
Description:
* Complete baseline questionnaires either online or on paper * Questionnaires will also be completed at 6 weeks, 12 weeks, and 16 weeks after baseline * Participants will be asked to wear an accelerometer for 7 days at baseline, 12 weeks, and 16 weeks. * Receive printed materials from the American Cancer Society about cancer management and standard physical activity recommendations. * Require physical evaluation and orientation to the WellAware gym * 12 week weight lifting program at WellAware Center * exercise physiologists will work with each patient to develop a custom routine * exercise load will start at 60% of one-repetition maximum and progress from 8 to 12 repetitions * 2-4 sets of repetition exercises will be performed to target upper \& lower muscle groups * resistance load will be added by 5 pounds when patients can complete more than 12 repetitions
Treatment:
Other: Godin Leisure-Time Exercise Questionnaire (GLTEQ)
Other: Questionnaire regarding behavior/lifestyle changes since diagnosis
Other: International Physical Activity Prevalence Study Environmental Module
Other: 12 week Resistance Training Program
Other: Community Health Activities Model Program for Seniors (CHAMPS)
Other: Lifetime Total Physical Activity Questionnaire
Other: Expanded Prostate Cancer Index Composite (EPIC)
Arm 3: Usual care
Active Comparator group
Description:
* Complete baseline questionnaires either online or on paper * Questionnaires will also be completed at 6 weeks, 12 weeks, and 16 weeks after baseline * Participants will be asked to wear an accelerometer for 7 days at baseline, 12 weeks, and 16 weeks. * Receive printed materials from the American Cancer Society about cancer management and standard physical activity recommendations.
Treatment:
Other: Godin Leisure-Time Exercise Questionnaire (GLTEQ)
Other: Questionnaire regarding behavior/lifestyle changes since diagnosis
Other: International Physical Activity Prevalence Study Environmental Module
Other: Community Health Activities Model Program for Seniors (CHAMPS)
Other: Lifetime Total Physical Activity Questionnaire
Other: Expanded Prostate Cancer Index Composite (EPIC)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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