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NCT Number: NCT04125108

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

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.

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Key information

Conditions

Inhalation Injury Burns Lung Diseases Pulmonary Disease Respiratory Tract Diseases Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hangang Sacred Heart Hospital

Seoul, Yeong-deungpo-Dong, 150-719, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pulmonary Rehabilitation

Other

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 outcomes

  1. FVC

    Time frame: 12 weeks

    forced vital capacity(%)

  2. FEV1

    Time frame: 12 weeks

    1 second forced expiratory volume(%)

  3. FEV1/FVC ratio

    Time frame: 12 weeks

    FEV1/FVC ratio expressed as a percentage(%)

Secondary outcomes

  1. MEP

    Time frame: 12 weeks

    maximal expiratory pressure

  2. MIP

    Time frame: 12 weeks

    maximal inspiratory pressure

  3. gait performance

    Time frame: 12 weeks

    6-minute walk test

Sponsors and collaborators

Lead sponsor

Hangang Sacred Heart Hospital

Other

Collaborators

  • Hallym University
  • National Research Foundation of Korea

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 14, 2019
Registry last updated
Feb 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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