Six-Minute Walk Test in the Evaluation of Patients at High Risk for Complications From Lung Resection
试验速览
- 阶段
- 不适用
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Correlation of pre-operative six-minute walk test results with that of the gold standard exercise test
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient's age is between 18-
- •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.
排除标准
- •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
结局指标
主要结局
Correlation of pre-operative six-minute walk test results with that of the gold standard exercise test
时间窗: 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.
次要结局
未报告次要终点