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Six-Minute Walk Test in the Evaluation of Patients at High Risk for Complications From Lung Resection


Phase 2
18 Years
90 Years
Open (Enrolling)
Both
Lung Cancer

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Trial Information

Six-Minute Walk Test in the Evaluation of Patients at High Risk for Complications From Lung Resection


Description of the Study Tests:

The exercise stress test is commonly used for predicting possible complications that may
occur after lung surgery. The 6-minute walk test is a simpler test that does not require as
much equipment.

6-Minute Walk Test: If you agree to take part in this research study, you will be asked to
perform two 6-minute walk tests along with your routine exercise stress test. Both 6-minute
walk tests will be done within 2 weeks of the already scheduled exercise stress test if your
clinical condition does not change during that time period. The 6-minute walk tests should
be done at least 2 hours before or 1 hour after the exercise stress test. The second
6-minute walk test may be done 20 minutes after the first one. If you had a 6-minute walk
test done within 2 weeks before enrolling in the study, it can be used for the study.

To perform the 6-minute walk tests, you will walk as far as possible around cones on a flat
indoor course that is about 40 yards long. You will walk at your own pace and can take
breaks at any time if necessary. After the 6 minutes, the study staff will tell you the
total distance you have walked.

Researchers will compare the distances you walked for the two 6-minute walk tests with the
results of the exercise stress test. The walk test results will not affect your treatment
plan.

Other Study Procedures:

Before and after the walk tests, the following procedures will be performed. Your blood
pressure will be measured. You will be asked about any shortness of breath and/or fatigue
you may have.

Before, during, and for about 1 minute after the walk tests, your heart rate will be
measured. A device that looks like a clothespin will be placed on your finger to wear
during this time, and it will measure the amount of oxygen in your blood.

Length of Study:

You will be considered off-study after the second walk test.

If you do have lung surgery, researchers will monitor your health status by checking your
medical records until you are discharged from the hospital or for 30 days after the lung
surgery, whichever comes first.

This is an investigational study. Using the 6-minute walk test for this study's purpose is
considered experimental. Up to 101 patients will take part in this study. All will be
enrolled at M. D. Anderson.


Inclusion Criteria:



1. Patient's age is between 18-90.

2. Patient has been referred for an oxygen consumption exercise test because they are
considered high risk for morbidity and/or mortality post lung resection

3. Patient must be able to read, understand and provide informed consent.

Exclusion Criteria:

1. Patients diagnosed with angina pectoris

2. Patients diagnosed with critical aortic stenosis

3. Patients with unstable gait that persists with use of assistive device

4. Patients unable to walk

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Equivalence Test

Outcome Time Frame:

An equivalence test will be performed to establish that the new test (six-minute walk) is comparable to the gold standard test (the VO2 peak) with an acceptable decreased sensitivity.

Safety Issue:

No

Principal Investigator

Carlos A. Jimenez, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2006-1061

NCT ID:

NCT00450125

Start Date:

February 2007

Completion Date:

Related Keywords:

  • Lung Cancer
  • Lung Cancer
  • Lung Resection
  • Exercise Stress Test
  • Six-Minute Walk Test
  • Lung Neoplasms

Name

Location
UT MD Anderson Cancer Center Houston, Texas  77030