Physical Activity Intervention in African American Men After Radical Prostatectomy

January 28, 2016 updated by: Washington University School of Medicine

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm 1: Aerobics
  • 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
Other: Community 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
Other: Lifetime 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
Other: Expanded 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
Other: International 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.
Other: Godin Leisure-Time Exercise Questionnaire (GLTEQ)
-4 item query of usual leisure time exercise habits
Other: Questionnaire regarding behavior/lifestyle changes since diagnosis
Other: 12 week Walking Program
Experimental: Arm 2: Resistance training
  • 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
Other: Community 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
Other: Lifetime 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
Other: Expanded 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
Other: International 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.
Other: Godin Leisure-Time Exercise Questionnaire (GLTEQ)
-4 item query of usual leisure time exercise habits
Other: Questionnaire regarding behavior/lifestyle changes since diagnosis
Other: 12 week Resistance Training Program
Active Comparator: Arm 3: Usual care
  • 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.
Other: Community 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
Other: Lifetime 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
Other: Expanded 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
Other: International 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.
Other: Godin Leisure-Time Exercise Questionnaire (GLTEQ)
-4 item query of usual leisure time exercise habits
Other: Questionnaire regarding behavior/lifestyle changes since diagnosis

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recruitment rate comparisons between physician referral and community advertisement
Time Frame: Completion of study (approximately 3.5 years)
Completion of study (approximately 3.5 years)
Attrition rate in each arm
Time Frame: 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
Completion of study (approximately 3.5 years)
Intervention effectiveness as measured by change in accelerometer measured physical activity
Time Frame: Completion of study (approximately 3.5 years)
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)
Time Frame: 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.
Completion of study (approximately 3.5 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Washington University School of Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lin Yang, Ph.D., Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2015

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 25, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 3, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 29, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 201410072

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings