Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00450125
Status:
UNKNOWN
Last Update Posted:
2019-05-15
First Post:
2007-03-19
Brief Title:
Six-Minute Walk Test in Patients at High Risk for Complications From Lung Resection
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Six-Minute Walk Test in the Evaluation of Patients at High Risk for Complications From Lung Resection
Status:
UNKNOWN
Status Verified Date:
2018-09
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 andor 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 studys purpose is considered experimental Up to 101 patients will take part in this study All will be enrolled at M D Anderson
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 andor 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 studys purpose is considered experimental Up to 101 patients will take part in this study All will be enrolled at M D Anderson
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None