Clinical trial NCT04178278: The Study for the Reliability and Validity of Incremental Shuttle Walking Test for COPD Patients in Korea
Official title: The Reliability and Validity of Incremental Shuttle Walking Test to Assess Exercise Capacity in Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Ulsan University Hospital
First posted: 2019-11-26
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Correlation between shuttle walking test, 6 minutes walking test and exercise stress test
timeFrame: 1 week
Secondary outcomes:
measure: Reproducibility in shuttle walking test
timeFrame: 1 week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center, University of Ulsan College of Medicine
state: Songpa
Study officials:
References: