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Feasibility of Endurance Exercise Training on Cardiovascular Risk Factors Following Radical Prostatectomy Among Men With Localized Prostate Cancer; A Community-Based Intervention


N/A
18 Years
N/A
Not Enrolling
Male
Prostatectomy

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Trial Information

Feasibility of Endurance Exercise Training on Cardiovascular Risk Factors Following Radical Prostatectomy Among Men With Localized Prostate Cancer; A Community-Based Intervention


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).


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Cardiorespiratory Fitness will be determined using a incremental treadmill test with 12-lead ECG monitoring.

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Lee Jones, PHd

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University

Authority:

United States: Institutional Review Board

Study ID:

Pro00002501

NCT ID:

NCT00620932

Start Date:

January 2008

Completion Date:

November 2008

Related Keywords:

  • Prostatectomy
  • Prostatic Neoplasms

Name

Location

Duke University Medical Center Preston Robert Tisch Brain Tumor CenterDurham, North Carolina  27710