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

NCT04178278 | Unknown

• 1 other identifier: KOR-SWT
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Reproducibility in shuttle walking test

  1 week

Study Arms (3)

Shuttle walking test group

EXPERIMENTAL

Patients will performed shultte walking test.

Diagnostic Test: Shuttle walking test

Exercise stress test group

ACTIVE COMPARATOR

Patients will performed exercise stress test.

Diagnostic Test: Exercise stress test

6 minutes walking test group

ACTIVE COMPARATOR

Patients will performed 6 minutes walking test.

Diagnostic Test: 6 minutes walking test

Interventions

Shuttle walking test 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

Shuttle walking test group

Exercise stress test 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.

Exercise stress test group

6 minutes walking test 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

6 minutes walking test group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asan Medical Center: lead
• Ulsan University Hospital: collaborator

Study Sites (1)

Asan Medical Center, University of Ulsan College of Medicine

Seoul, Songpa, 05505, South Korea

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 13, 2019
• First Posted: November 26, 2019
• Study Start: December 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: November 27, 2019

Record last verified: 2019-11

Locations

KR (1)