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

NCT ID: NCT04125108

Last Updated: 2020-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-10
• Study Completion Date: 2020-01-30

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.

Conditions

Inhalation Injury; Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

pulmonary rehabilitation

Intervention Type: 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.

control group

The control group was to participate in a 12-week conventional rehabilitation program.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Research Foundation of Korea

OTHER

Sponsor Role: collaborator

Hallym University

OTHER

Sponsor Role: collaborator

Hangang Sacred Heart Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hangang Sacred Heart Hospital

Seoul, Yeong-deungpo-Dong, South Korea

Countries

South Korea

References

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.

Reference Type: RESULT

PMID: 20354445 (View on PubMed)

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.

Reference Type: RESULT

PMID: 31504621 (View on PubMed)

Other Identifiers

HangangSHH-6

Identifier Type: -

Identifier Source: org_study_id