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

NCT00450125 | Unknown

• 1 other identifier: 2006-1061
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Keywords

Lung Cancer; Lung Resection; Exercise Stress Test; Six-Minute Walk Test

Outcome Measures

Primary Outcomes (1)

• Correlation of pre-operative six-minute walk test results with that of the gold standard exercise 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.

  Up to 15 days to complete 3 tests (two six-minute walk tests and a stress test)

Study Arms (1)

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; Other: Exercise stress test

Interventions

Six-Minute Walk Test OTHER

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

Six-Minute Walk Test

Exercise stress test OTHER

Scheduled gold standard exercise test, i.e. stress test, cycle ergometry with incremental workloads or oxygen consumption exercise studies

Also known as: Stress test, oxygen consumption exercise test, gold standard exercise test

Six-Minute Walk Test

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients at high risk for complications from lung resection.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Officials

• Carlos A. Jimenez, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2007
• First Posted: March 21, 2007
• Study Start: February 1, 2007
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: May 15, 2019

Record last verified: 2018-09

Locations

US (1)