The Effect of a Pulmonary Rehabilitation on Lung Function and Exercise Capacity in Patients With Burn: a Prospective Randomized Single Blind Study
| Registry | NCT04125108 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, single group, masking: none, treatment |
| Enrollment | 120 (Actual) |
| Sponsor | Hangang Sacred Heart Hospital (Other); collaborators: National Research Foundation of Korea, Hallym University |
| Conditions | Inhalation Injury, Pulmonary Disease |
| Interventions | pulmonary rehabilitation (Other) |
| Dates | start 2019-10-10, primary completion 2020-01-10, completion 2020-01-30, first posted 2019-10-14, last updated 2020-02-10 |
| Locations | 1 site in South Korea |
Related Papers Related Patents Related Grants Related Experts
All trials for Inhalation Injury All trials for Pulmonary Disease All trials of pulmonary rehabilitation
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| pulmonary rehabilitation group | Experimental | Other: pulmonary rehabilitation | The experimental group was to participate in a 12-week pulmonary rehabilitation program supplemented with an individualized and supervised exercise-training program. |
| control group | No intervention | The control group was to participate in a 12-week conventional rehabilitation program. |
Sex: All, ages: 18 Years to 60 Years
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Hangang Sacred Heart Hospital | Seoul, Yeong-deungpo-Dong | South Korea |