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

Asan Medical Center

Status: Unknown

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Diagnostic Test: 6 minutes walking test; Diagnostic Test: Exercise stress test; Diagnostic Test: Shuttle walking test

Study type: Interventional

Funder types: Other

Identifiers

NCT04178278

KOR-SWT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Shuttle walking test group

Experimental group

Description:

Patients will performed shultte walking test.

Treatment:

Diagnostic Test: Shuttle walking test

Exercise stress test group

Active Comparator group

Description:

Patients will performed exercise stress test.

Treatment:

Diagnostic Test: Exercise stress test

6 minutes walking test group

Active Comparator group

Description:

Patients will performed 6 minutes walking test.

Treatment:

Diagnostic Test: 6 minutes walking test