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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by M.D. Anderson Cancer Center
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00450125
First received: March 19, 2007
Last updated: October 30, 2014
Last verified: October 2014
  Purpose

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 Intervention Phase
Lung Cancer
Other: Six-Minute Walk Test
Other: Exercise stress test
Phase 2

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Correlation of pre-operative six-minute walk test results with that of the gold standard exercise test [ Time Frame: Up to 2 weeks to complete 3 tests (two six-minute walk tests and a stress test) ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 101
Study Start Date: February 2007
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Six-Minute Walk Test
Two Six-minute walk tests where total distance walked measured. Tests performed within 2 weeks 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

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 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.

  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:

  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
  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: NCT00450125

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

Locations
United States, Texas
University of Texas MD 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 M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00450125     History of Changes
Other Study ID Numbers: 2006-1061
Study First Received: March 19, 2007
Last Updated: October 30, 2014
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Lung Neoplasms
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on November 25, 2014