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

Sponsor
Asan Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT04178278
Collaborator
Ulsan University Hospital (Other)
30
1
3
25
1.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Shuttle walking test
  • Diagnostic Test: Exercise stress test
  • Diagnostic Test: 6 minutes walking test
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
The Reliability and Validity of Incremental Shuttle Walking Test to Assess Exercise Capacity in Patients With Chronic Obstructive Pulmonary Disease
Anticipated Study Start Date :
Dec 1, 2019
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Dec 31, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Correlation between shuttle walking test, 6 minutes walking test and exercise stress test [1 week]

    Correlation between walking distance in shuttle walking test, walking distance in 6 minutes walking test and maximal oxygen uptake in exercise stress test

Secondary Outcome Measures

  1. Reproducibility in shuttle walking test [1 week]

    correlation between 2 times of walking distance in each shuttle walking test

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Asan Medical Center, University of Ulsan College of Medicine Seoul Songpa Korea, Republic of 05505

Sponsors and Collaborators

  • Asan Medical Center
  • Ulsan University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sei Won Lee, Associate Professor, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT04178278
Other Study ID Numbers:
  • KOR-SWT
First Posted:
Nov 26, 2019
Last Update Posted:
Nov 27, 2019
Last Verified:
Nov 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 27, 2019