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

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: NCT00450125
Recruitment Status : Active, not recruiting
First Posted : March 21, 2007
Last Update Posted : September 25, 2017
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
The goal of this clinical research study is to compare the 6-minute walk test with the exercise stress test, in patients who may have lung surgery. Researchers want to find out if the 6-minute walk test is as good as the exercise stress test at predicting possible complications that may occur after lung surgery.

Condition or disease Intervention/treatment
Lung Cancer Other: Six-Minute Walk Test Other: Exercise stress test

Detailed Description:

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 15 Days 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 15 Days 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.

Study Type : Observational
Estimated Enrollment : 101 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Six-Minute Walk Test in the Evaluation of Patients at High Risk for Complications From Lung Resection
Actual Study Start Date : February 2007
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Six-Minute Walk Test
Two Six-minute walk tests where total distance walked measured. Tests performed within 15 days of an exercise stress test.
Other: Six-Minute Walk Test
Six-Minute walk tests at least one hour after vigorous exertion (such as exercise stress test) and at least 20 minutes in between the first and second six-minute walk tests
Other: Exercise stress test
Scheduled gold standard exercise test, i.e. stress test, cycle ergometry with incremental workloads or oxygen consumption exercise studies
Other Names:
  • Stress test
  • oxygen consumption exercise test
  • gold standard exercise test

Primary Outcome Measures :
  1. Correlation of pre-operative six-minute walk test results with that of the gold standard exercise test [ Time Frame: Up to 15 days to complete 3 tests (two six-minute walk tests and a stress test) ]
    Results used to correlate the pre-operative six-minute walk test results with that of the gold standard exercise test (stress test) through analysis of gas exchange and measurement of oxygen uptake [oxygen volume (VO2)]. For the six-minute walk tests, recorded parameters are distance walked and pulse oximetry saturation percentage levels, and for gold standard exercise test, recorded are the gas exchange and measurement of oxygen uptake (VO2, ml/kg/min). Equivalence test 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.

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 to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients at high risk for complications from lung resection.

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

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): NCT00450125

United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Principal Investigator: Carlos A. Jimenez, MD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00450125     History of Changes
Other Study ID Numbers: 2006-1061
First Posted: March 21, 2007    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017

Keywords provided by M.D. Anderson Cancer Center:
Lung Cancer
Lung Resection
Exercise Stress Test
Six-Minute Walk Test