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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04125108
Enrollment
120
Registered
2019-10-14
Start date
2019-10-10
Completion date
2020-01-30
Last updated
2020-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inhalation Injury, Pulmonary Disease

Keywords

burn, Pulmonary Function Test, Pulmonary Rehabilitation

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.

Interventions

OTHERpulmonary 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.

Sponsors

National Research Foundation of Korea
CollaboratorOTHER
Hallym University
CollaboratorOTHER
Hangang Sacred Heart Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
FVC12 weeksforced vital capacity(%)
FEV112 weeks1 second forced expiratory volume(%)
FEV1/FVC ratio12 weeksFEV1/FVC ratio expressed as a percentage(%)

Secondary

MeasureTime frameDescription
MEP12 weeksmaximal expiratory pressure
MIP12 weeksmaximal inspiratory pressure
gait performance12 weeks6-minute walk test

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026