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

Purpose

Primary Objectives:

To assess the correlation of the pre-operative six-minute walk test results with that of the gold standard exercise test with analysis of gas exchange and measurement of oxygen uptake (O2).
To perform equivalence test of the six-minute walk test compared to the gold standard exercise test.

Secondary Objectives:

To compare the results of six-minute walk test between patients who underwent surgery who had and did not have post-operative morbidity and mortality.
Subgroup analysis by pulse oximetry saturation percentage levels.

Condition	Intervention	Phase
Lung Cancer	Other: Six-Minute Walk Test	Phase II

MedlinePlus related topics:

Cancer Exercise and Physical Fitness Lung Cancer Stress

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective

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

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

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. [ Time Frame: 18 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. [ Time Frame: 18 Months ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	101
Study Start Date:	February 2007
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Patients at high risk for complications from lung resection.	Other: Six-Minute Walk Test Two 6-minute walk tests where the total distance walked will be measured.

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. The first 6-minute walk test will be done either the day or 2 hours before the already scheduled exercise stress test, or at least 1 hour after it. The second 6-minute walk test will be done at least 20 minutes after the first one.

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 tally 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 clothepin 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. The 6-minute walk test will be performed at no cost to you. Up to 101 patients will take part in this study. All will be enrolled at M. D. Anderson.

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients at high risk for complications from lung resection.

Criteria

Inclusion Criteria:

Patient's age is between 18-90.
Patient has been referred for an oxygen consumption exercise test because they are considered high risk for morbidity and/or mortality post lung resection
Patient must be able to read, understand and provide informed consent.

Exclusion Criteria:

Patients diagnosed with angina pectoris
Patients diagnosed with critical aortic stenosis
Patients with unstable gait that persists with use of assistive device
Patients unable to walk

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00450125

Contacts


Contact: Carlos A. Jimenez, MD	713-563-4260

Locations


United States, Texas
	U.T.M.D. Anderson Cancer Center	Recruiting
	Houston, Texas, United States, 77030
	Principal Investigator: Carlos A. Jimenez, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators


Principal Investigator:	Carlos A. Jimenez, MD	U.T.M.D. Anderson Cancer Center

More Information

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Carlos A. Jimenez, MD/Associate Professor )
Study ID Numbers:	2006-1061
First Received:	March 19, 2007
Last Updated:	March 11, 2008
ClinicalTrials.gov Identifier:	NCT00450125
Health Authority:	United States: Institutional Review Board