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

Not Applicable

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Diagnostic Test: Exercise stress test; Diagnostic Test: 6 minutes walking test; Diagnostic Test: Shuttle walking test

• Registration Number: NCT04178278
• Lead Sponsor: Asan Medical Center

Brief Summary

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

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.

Study Timeline

• Status Verified: 2019-11
• Study First Submitted: 2019-11-13
• Study First Submitted QC: 2019-11-25
• Study First Posted: 2019-11-26
• Last Update Submitted: 2019-11-26
• Last Update Posted: 2019-11-27
• Study Start: 2019-12-01
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Exercise stress test group	Exercise stress test	Patients will performed exercise stress test.
6 minutes walking test group	6 minutes walking test	Patients will performed 6 minutes walking test.
Shuttle walking test group	Shuttle walking test	Patients will performed shultte walking test.

Primary Outcome Measures

Name	Time	Method
Correlation between shuttle walking test, 6 minutes walking test and exercise stress test	1 week	Correlation between walking distance in shuttle walking test, walking distance in 6 minutes walking test and maximal oxygen uptake in exercise stress test

Secondary Outcome Measures

Name	Time	Method
Reproducibility in shuttle walking test	1 week	correlation between 2 times of walking distance in each shuttle walking test

Trial Locations

Locations (1)

Asan Medical Center, University of Ulsan College of Medicine; 🇰🇷 Seoul, Songpa, Korea, Republic of