The Effect of a Pulmonary Rehabilitation on Lung Function and Exercise Capacity in Patients With Burn
Primary Purpose
Inhalation Injury, Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
pulmonary rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Inhalation Injury focused on measuring burn, Pulmonary Function Test, Pulmonary Rehabilitation
Eligibility Criteria
Inclusion Criteria:
- inhalation injury
- The burn surface area of chest and neck are more than 50% of the anterior or posterior trunk areas.
Exclusion Criteria:
- vocal cord palsy
- who were intubated
- had a tracheostomy
- anoxic brain injury
- psychologicical disorders
- quadriplegia
- severe cognitive disorders
- who took medications that affect pulmonary function.
Sites / Locations
- Hangang Sacred Heart Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
pulmonary rehabilitation group
control group
Arm Description
The experimental group was to participate in a 12-week pulmonary rehabilitation program supplemented with an individualized and supervised exercise-training program.
The control group was to participate in a 12-week conventional rehabilitation program.
Outcomes
Primary Outcome Measures
FVC
forced vital capacity(%)
FEV1
1 second forced expiratory volume(%)
FEV1/FVC ratio
FEV1/FVC ratio expressed as a percentage(%)
Secondary Outcome Measures
MEP
maximal expiratory pressure
MIP
maximal inspiratory pressure
gait performance
6-minute walk test
Full Information
NCT ID
NCT04125108
First Posted
October 10, 2019
Last Updated
February 6, 2020
Sponsor
Hangang Sacred Heart Hospital
Collaborators
National Research Foundation of Korea, Hallym University
1. Study Identification
Unique Protocol Identification Number
NCT04125108
Brief Title
The Effect of a Pulmonary Rehabilitation on Lung Function and Exercise Capacity in Patients With Burn
Official Title
The Effect of a Pulmonary Rehabilitation on Lung Function and Exercise Capacity in Patients With Burn: a Prospective Randomized Single Blind Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
October 10, 2019 (Actual)
Primary Completion Date
January 10, 2020 (Actual)
Study Completion Date
January 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hangang Sacred Heart Hospital
Collaborators
National Research Foundation of Korea, Hallym University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Inhalation burn injury and lung complications caused by large surface burns occurring during a fire remains a serious problem. Pulmonary rehabilitation has been used successfully to improve pulmonary function(PF) in patients with chronic obstructive pulmonary disease. But there were no studies that pulmonary rehabilitation induce improvements in PF in patient with large surface burn and inhalation injury.
The investigators will performe pulmonary function and respiratory muscles strength evaluation in 40 patients with thermal injury in order to evaluate the effects of pulmonary rehabilitation in patients with thermally injury.
Detailed Description
The investigators will performe pulmonary function and respiratory muscles strength evaluation in 40 patients with thermal injury in order to evaluate the effects of pulmonary rehabilitation in patients with thermally injury.
The investigators will study 40 patients who had burn injury. Burned patients will be randomized into two groups. The experimental group(EG) will participate in a 12-week pulmonary rehabilitation program daily for 60 minutes. The control group(CG) will participate in a 12-week conventional exercise program daily for 60 minutes. Spirometer will be done to evaluate pulmonary function. Pulmonary function tests include forced vital capacity(FVC), 1 second forced expiratory volume(FEV1), forced expiratory flow rate between 25 and 75% of the FVC(FEF 25-75) FEV1/FVC ratio expressed as a percentage(FEV1/FVC %) and peak expiratory flow(PEF). Maximum voluntary ventilation(MVV) and respiratory muscles strength(MEP[maximal expiratory pressure], MIP[maximal inspiratory pressure]) will be measured by mouth pressure-meter in sitting position. Pulmonary function tests will be performed for all groups at baseline and after 12 weeks programs. A 6-minute walk test and health-related quality of life will be also evaluated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inhalation Injury, Pulmonary Disease
Keywords
burn, Pulmonary Function Test, Pulmonary Rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The patients with inhalation injury, chest and neck burn injury were included. The burn surface area of chest and neck are more than 50% of the anterior or posterior trunk areas.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
pulmonary rehabilitation group
Arm Type
Experimental
Arm Description
The experimental group was to participate in a 12-week pulmonary rehabilitation program supplemented with an individualized and supervised exercise-training program.
Arm Title
control group
Arm Type
No Intervention
Arm Description
The control group was to participate in a 12-week conventional rehabilitation program.
Intervention Type
Other
Intervention Name(s)
pulmonary rehabilitation
Intervention Description
Pulmonary rehabilitation programs were designed to include both 30 minutes resistance and 30 minutes aerobic exercises. Eight basic resistnace exercises were used incorporating, bench press, leg press, leg curl, leg extension, toe raises, biceps curl, triceps curl, shoulder press. Additionally each exercise training session also included aerobic conditioning exercises ona treadmill or cycle ergometer. Aerobic exercise training was carried out 5 days per week, with each session lasting 30 minutes. All exercise sessions were preceded by a 5-minutes warm up period on a treadmill set.
Primary Outcome Measure Information:
Title
FVC
Description
forced vital capacity(%)
Time Frame
12 weeks
Title
FEV1
Description
1 second forced expiratory volume(%)
Time Frame
12 weeks
Title
FEV1/FVC ratio
Description
FEV1/FVC ratio expressed as a percentage(%)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
MEP
Description
maximal expiratory pressure
Time Frame
12 weeks
Title
MIP
Description
maximal inspiratory pressure
Time Frame
12 weeks
Title
gait performance
Description
6-minute walk test
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
inhalation injury
The burn surface area of chest and neck are more than 50% of the anterior or posterior trunk areas.
Exclusion Criteria:
vocal cord palsy
who were intubated
had a tracheostomy
anoxic brain injury
psychologicical disorders
quadriplegia
severe cognitive disorders
who took medications that affect pulmonary function.
Facility Information:
Facility Name
Hangang Sacred Heart Hospital
City
Seoul
State/Province
Yeong-deungpo-Dong
ZIP/Postal Code
150-719
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
20354445
Citation
Al-Mousawi AM, Williams FN, Mlcak RP, Jeschke MG, Herndon DN, Suman OE. Effects of exercise training on resting energy expenditure and lean mass during pediatric burn rehabilitation. J Burn Care Res. 2010 May-Jun;31(3):400-8. doi: 10.1097/BCR.0b013e3181db5317.
Results Reference
result
PubMed Identifier
31504621
Citation
Ring J, Heinelt M, Sharma S, Letourneau S, Jeschke MG. Oxandrolone in the Treatment of Burn Injuries: A Systematic Review and Meta-analysis. J Burn Care Res. 2020 Jan 30;41(1):190-199. doi: 10.1093/jbcr/irz155.
Results Reference
result
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The Effect of a Pulmonary Rehabilitation on Lung Function and Exercise Capacity in Patients With Burn
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