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

Overview

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.

Full Title of Study: “The Effect of a Pulmonary Rehabilitation on Lung Function and Exercise Capacity in Patients With Burn: a Prospective Randomized Single Blind Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 10, 2020

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.

Interventions

  • Other: pulmonary rehabilitation
    • 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.

Arms, Groups and Cohorts

  • Experimental: pulmonary rehabilitation group
    • The experimental group was to participate in a 12-week pulmonary rehabilitation program supplemented with an individualized and supervised exercise-training program.
  • No Intervention: control group
    • The control group was to participate in a 12-week conventional rehabilitation program.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • MEP
    • Time Frame: 12 weeks
    • maximal expiratory pressure
  • MIP
    • Time Frame: 12 weeks
    • maximal inspiratory pressure
  • gait performance
    • Time Frame: 12 weeks
    • 6-minute walk test

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hangang Sacred Heart Hospital
  • Collaborator
    • National Research Foundation of Korea
  • Provider of Information About this Clinical Study
    • Sponsor

Citations Reporting on Results

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.

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.

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