The Study for the Reliability and Validity of Incremental Shuttle Walking Test for COPD Patients in Korea

Study Overview
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Brief Summary
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Investigators will perform this study to validate shuttle walking tests in korean patients with chronic obstructive pulmonary disease. This study will be performed as multi-center prospective observational correlation study in ulsan university hospital and asan medical center. 36 participants will perform the exercise stress test with cycle, 6 minutes walking test and shuttle walking test. Investigators will analyze correlation 6 minutes walking test and shuttle walking test with exercise stress test.

Detailed Description
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Investigators will perform this study to validate shuttle walking tests in korean patients with chronic obstructive pulmonary disease. This study will be performed as multi-center prospective observational correlation study in ulsan university hospital and asan medical center. 18 patients will be enrolled in each hospital. When then visit, patients will perform questionnaire and laboratory study for baseline characteristics. After that, patients select memo, in which order for the exercise stress test with cycle, 6 minutes walking test and shuttle walking test will be written. Along that order, patients will perform each study at every two day in a week. Investigators will analyze correlation 6 minutes walking test and shuttle walking test with exercise stress test. To analyze reliability in shuttle walking test, patients will shuttle walking test in two times. Researchers will analyze correlation between them.

Official Title
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The Reliability and Validity of Incremental Shuttle Walking Test to Assess Exercise Capacity in Patients With Chronic Obstructive Pulmonary Disease

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Diagnostic Test: Shuttle walking test
* Diagnostic Test: Exercise stress test
* Diagnostic Test: 6 minutes walking test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with respiratory symptom patients with forced expiratory volume 1/forced vital capacity < 0.7 in pulmonary function test after bronchodilator patients with informed consent Exclusion Criteria: history of unstable angina or myocardial infarction within 1 month more than 120/mins pulse rate in stable state uncontrolled arrhythmia or history of syncope Symptomatic aortic stenosis or severe cardiac valve stenosis acute pulmonary embolism, deep vein thrombosis, aortic dissection or pulmonary edema difficult condition for shuttle walking test; visual, auditory or psychological disturbance respiratory failure oxygen saturation ≤ 85% in stable state needs for oxygen supply during walking active infection, acute infective endocarditis, renal failure, hyperthyroidism or significant pulmonary hypertension Left main coronary artery stenosis, hypertrophic cardiomyopathy systolic blood pressure more than 180 mmHg diastolic blood pressure more than 100 mmHg pregnant women patients with orthopedic disease

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Shuttle walking test group<br>Patients will performed shultte walking test. | Diagnostic Test: Shuttle walking test<br>* Patients will be required to walk around a 10-m course marked by cones placed 9 m apart, thus allowing 0.5 m for turning at each end. Walking speed will be regulated by prerecorded signals on a compact disc or MP3 file. Patients will increase walking speed at every minute. patients can stop this study, when they can not maintain their speeds due to dyspnea<br>|
| Active Comparator: Exercise stress test group<br>Patients will performed exercise stress test. | Diagnostic Test: Exercise stress test<br>* Exercise stress test will be performed with cycle. When patients perform this study, they will gradually increase the velocity. Investigators will measure electrocardiography, vital sign, oxygen saturation, oxygen uptake, minute ventilation and fatigue.<br>|
| Active Comparator: 6 minutes walking test group<br>Patients will performed 6 minutes walking test. | Diagnostic Test: 6 minutes walking test<br>* When participants perform 6 minutes walking test, patients will walk around the tract during 6 minutes. They can their walking speed according to condition and symptom. Investigators records walking distance, pulse rate, oxygen saturation and Borg scale<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between shuttle walking test, 6 minutes walking test and exercise stress test | Correlation between walking distance in shuttle walking test, walking distance in 6 minutes walking test and maximal oxygen uptake in exercise stress test | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reproducibility in shuttle walking test | correlation between 2 times of walking distance in each shuttle walking test | 1 week |