The Effect of a Pulmonary Rehabilitation on Lung Function and Exercise Capacity in Patients With Burn

Not Applicable

Completed

• Conditions: Inhalation Injury; Pulmonary Disease
• Interventions: Other: pulmonary rehabilitation

• Registration Number: NCT04125108
• Lead Sponsor: Hangang Sacred Heart Hospital

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.

Study Timeline

• Status Verified: 2019-10
• Study Start: 2019-10-10
• Study First Submitted: 2019-10-10
• Study First Submitted QC: 2019-10-10
• Study First Posted: 2019-10-14
• Primary Completion: 2020-01-10
• Study Completion: 2020-01-30
• Last Update Submitted: 2020-02-06
• Last Update Posted: 2020-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
pulmonary rehabilitation group	pulmonary rehabilitation	The experimental group was to participate in a 12-week pulmonary rehabilitation program supplemented with an individualized and supervised exercise-training program.

Primary Outcome Measures

Name	Time	Method
FVC	12 weeks	forced vital capacity(%)
FEV1	12 weeks	1 second forced expiratory volume(%)
FEV1/FVC ratio	12 weeks	FEV1/FVC ratio expressed as a percentage(%)

Secondary Outcome Measures

Name	Time	Method
MEP	12 weeks	maximal expiratory pressure
MIP	12 weeks	maximal inspiratory pressure
gait performance	12 weeks	6-minute walk test

Trial Locations

Locations (1)

Hangang Sacred Heart Hospital; 🇰🇷 Seoul, Yeong-deungpo-Dong, Korea, Republic of