Exercise Training Among Men With Prostate Cancer

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00620932
First received: February 12, 2008
Last updated: October 25, 2013
Last verified: October 2013
  Purpose

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 Intervention
Prostatectomy
Behavioral: Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Cardiorespiratory Fitness will be determined using a incremental treadmill test with 12-lead ECG monitoring. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fasting lipids will be assessed. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: January 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Name: Exercise

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.

    OR

  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).
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00620932

Locations
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
Investigators
Principal Investigator: Lee Jones, PHd Duke University
  More Information

Additional Information:
No publications provided by Duke University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00620932     History of Changes
Other Study ID Numbers: Pro00002501
Study First Received: February 12, 2008
Last Updated: October 25, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 14, 2014