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

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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Diagnostic test: Shuttle walking test; Diagnostic test: Exercise stress test; Diagnostic test: 6 minutes walking 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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Songpa
    • Seoul, Songpa, Korea, Republic of, 05505
      • Asan Medical Center, University of Ulsan College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Shuttle walking test group; Patients will performed shultte walking test.	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
Active Comparator: Exercise stress test group; Patients will performed exercise stress test.	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.
Active Comparator: 6 minutes walking test group; Patients will performed 6 minutes walking test.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reproducibility in shuttle walking test	correlation between 2 times of walking distance in each shuttle walking test	1 week

Collaborators and Investigators

• Sponsor: Asan Medical Center
• Collaborators: Ulsan University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2019
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: November 13, 2019
• First Submitted That Met QC Criteria: November 25, 2019
• First Posted (Actual): November 26, 2019

Study Record Updates

• Last Update Posted (Actual): November 27, 2019
• Last Update Submitted That Met QC Criteria: November 26, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: KOR-SWT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No