Clinical trial NCT04125108: 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
Overall status: COMPLETED
Phase: NA
Conditions: Inhalation Injury
Pulmonary Disease
Keywords: burn
Pulmonary Function Test
Pulmonary Rehabilitation
Lead sponsor: Hangang Sacred Heart Hospital
Sponsor class: OTHER
Collaborators: name: National Research Foundation of Korea
name: Hallym University
First posted: 2019-10-14
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: FVC
timeFrame: 12 weeks
measure: FEV1
timeFrame: 12 weeks
measure: FEV1/FVC ratio
timeFrame: 12 weeks
Secondary outcomes:
measure: MEP
timeFrame: 12 weeks
measure: MIP
timeFrame: 12 weeks
measure: gait performance
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hangang Sacred Heart Hospital
state: Yeong-deungpo-Dong
Study officials:
References:
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.
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.