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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Shuttle walking test
Exercise stress test
6 minutes walking test
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Asan Medical Center, University of Ulsan College of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Shuttle walking test group

Exercise stress test group

6 minutes walking test group

Arm Description

Patients will performed shultte walking test.

Patients will performed exercise stress test.

Patients will performed 6 minutes walking test.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 13, 2019
Last Updated
November 26, 2019
Sponsor
Asan Medical Center
Collaborators
Ulsan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04178278
Brief Title
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

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2019 (Anticipated)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center
Collaborators
Ulsan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Shuttle walking test group
Arm Type
Experimental
Arm Description
Patients will performed shultte walking test.
Arm Title
Exercise stress test group
Arm Type
Active Comparator
Arm Description
Patients will performed exercise stress test.
Arm Title
6 minutes walking test group
Arm Type
Active Comparator
Arm Description
Patients will performed 6 minutes walking test.
Intervention Type
Diagnostic Test
Intervention Name(s)
Shuttle walking test
Intervention Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
Exercise stress test
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
6 minutes walking test
Intervention Description
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
Primary Outcome Measure Information:
Title
Correlation between shuttle walking test, 6 minutes walking test and exercise stress test
Description
Correlation between walking distance in shuttle walking test, walking distance in 6 minutes walking test and maximal oxygen uptake in exercise stress test
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Reproducibility in shuttle walking test
Description
correlation between 2 times of walking distance in each shuttle walking test
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Asan Medical Center, University of Ulsan College of Medicine
City
Seoul
State/Province
Songpa
ZIP/Postal Code
05505
Country
Korea, Republic of

12. IPD Sharing Statement

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

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