Exercise Training Among Men With Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00620932
Recruitment Status : Withdrawn
First Posted : February 22, 2008
Last Update Posted : October 28, 2013
Information provided by (Responsible Party):
Duke University

Brief Summary:
The primary objective is to determine the feasibility and acceptability of a home-based endurance exercise program among men diagnosed with clinically localized prostate cancer.

Condition or disease Intervention/treatment Phase
Prostatectomy Behavioral: Exercise Not Applicable

Detailed Description:

Approximately 40 people will take part in this study and all of these people will take part at Duke University Medical Center.

Participation in this study involves the following.

  • We will ask you to perform a cardiopulmonary exercise test (walking stress test) to determine if you have any undiagnosed cardiovascular health problems that may limit your ability to participate in an exercise training program. This test will take place at the Duke Center for Living on Duke University Campus.
  • Complete a body composition assessment. This test is designed to determine your body fat and lean body tissue (muscle mass) percentage and will consist of you sitting quietly in a chamber with appropriate medical supervision. This test also will take place at the Duke Center for Living on Duke University Campus.
  • Complete two questionnaires one at the beginning and one at the end that asks about how you are feeling and about your physical activity levels. The questionnaire takes about 20-30 minutes.
  • Provide two blood samples one at the beginning and one at the end to measure levels of cardiovascular disease risk factors (cholesterol levels, c-reactive protein and insulin levels) in your blood that may be influenced by exercise. Blood collection will be drawn by medical staff at Duke University. The amount of blood drawn is approximately 2 teaspoons (10ml).
  • We will also collect information on how much treatment you receive as well as how many and what type of side-effects you have from your medical treatment. This information will be obtained from your medical chart following the completion of your treatment.

Following the successful completion of all initial tests and procedures (as described above), you will be randomly assigned (like flipping a coin) to one of the following two groups:

  1. Exercise Training Group: You will be given a customized training program aimed at increasing cardiorespiratory fitness. You will be asked to exercise 3 to 5 times per week. All sessions will include a 5 minute warm-up and 5 minute cool-down at the beginning and end of each session totaling 30-45 minutes per session. You will also receive a heart rate monitor to record each exercise session to monitor adherence and compliance. You will receive telephone calls every two weeks to provide encouragement, outline goals, and provide feedback on study progress.


  2. Wait-List Control Group: You will be asked to maintain your usual exercise levels during the 6 month study period. You will receive telephone calls to report your levels of exercise during the study. After study completion you will receive a heart rate monitor and an individualized exercise prescription based on your cardiorespiratory fitness test at the end of the study period (6 months).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Feasibility of Endurance Exercise Training on Cardiovascular Risk Factors Following Radical Prostatectomy Among Men With Localized Prostate Cancer; A Community-Based Intervention
Study Start Date : January 2008
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: Control Group
These patients will continue with whatever routine exercise they already engage in.
Experimental: Exercise Arm
These patients will participate in a controlled, supervised exercise program.
Behavioral: Exercise
Patients will be randomly assigned to groups and will either be given an exercise program individually tailored to them for them to participate in for 6 months or else be wait-listed for 6 months and remain on whatever exercise regimen they were already on.

Primary Outcome Measures :
  1. Cardiorespiratory Fitness will be determined using a incremental treadmill test with 12-lead ECG monitoring. [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Fasting lipids will be assessed. [ Time Frame: 6 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Legal age (>18 years old)
  2. An interval of at least 6 weeks between prior radical prostatectomy and study enrollment
  3. Karnofsky performance status of at least 70% at study entry
  4. Estimated life expectancy of ≥6 months
  5. Ability to read and understand English
  6. Attending urologist approval
  7. Signed informed consent
  8. Willingness to be randomized; and
  9. No contraindications to exercise as recommended by the American Thoracic Society

Exclusion Criteria:

  1. Acute myocardial infarction (6 weeks)
  2. Unstable angina
  3. Uncontrolled arrhythmias causing symptoms or hemodynamic compromise
  4. Syncope
  5. Acute endocarditis
  6. Acute myocarditis or pericarditis
  7. Uncontrolled heart failure
  8. Acute pulmonary embolus or pulmonary infarction
  9. Thrombosis of lower extremities
  10. Suspected dissecting aneurysm
  11. Uncontrolled asthma
  12. Pulmonary edema
  13. Room air desaturation at rest ≤85%
  14. Respiratory failure
  15. Acute noncardiopulmonary disorder that may affect exercise performance or be aggravated by exercise; and
  16. Mental impairment leading to inability to cooperate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00620932

United States, North Carolina
Duke University Medical Center Preston Robert Tisch Brain Tumor Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Principal Investigator: Lee Jones, PHd Duke University

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Duke University Identifier: NCT00620932     History of Changes
Other Study ID Numbers: Pro00002501
First Posted: February 22, 2008    Key Record Dates
Last Update Posted: October 28, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases