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

NCT ID: NCT04178278

Last Updated: 2019-11-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-01
• Study Completion Date: 2021-12-31

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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Shuttle walking test group

Patients will performed shultte walking test.

Group Type: EXPERIMENTAL

Shuttle walking test

Intervention Type: DIAGNOSTIC_TEST

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

Exercise stress test group

Patients will performed exercise stress test.

Group Type: ACTIVE_COMPARATOR

Exercise stress test

Intervention Type: DIAGNOSTIC_TEST

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.

6 minutes walking test group

Patients will performed 6 minutes walking test.

Group Type: ACTIVE_COMPARATOR

6 minutes walking test

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Shuttle walking test

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

Intervention Type: DIAGNOSTIC_TEST

Exercise stress test

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.

Intervention Type: DIAGNOSTIC_TEST

6 minutes walking test

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ulsan University Hospital

OTHER

Sponsor Role: collaborator

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Sei Won Lee

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Asan Medical Center, University of Ulsan College of Medicine

Seoul, Songpa, South Korea

Countries

South Korea

Other Identifiers

KOR-SWT

Identifier Type: -

Identifier Source: org_study_id