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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04178278
• Other study ID #: KOR-SWT
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: November 2019
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Diagnostic Test:
• 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
• 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.
• 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

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center, University of Ulsan College of Medicine	Seoul	Songpa

Sponsors (2)

Lead Sponsor	Collaborator
Asan Medical Center	Ulsan University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Reproducibility in shuttle walking test	correlation between 2 times of walking distance in each shuttle walking test	1 week