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

Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04125108
• Other study ID #: HangangSHH-6
• Status: Completed
• Phase: N/A
• Start date: October 10, 2019
• Est. completion date: January 30, 2020

Study information

• Verified date: October 2019
• Source: Hangang Sacred Heart Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 30, 2020
• Est. primary completion date: January 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Inhalation Injury
• Pulmonary Disease
• Respiratory Aspiration

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Hangang Sacred Heart Hospital	Seoul	Yeong-deungpo-Dong

Sponsors (3)

Lead Sponsor	Collaborator
Hangang Sacred Heart Hospital	Hallym University, National Research Foundation of Korea

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

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.0b013e3181db — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FVC	forced vital capacity(%)	12 weeks
Primary	FEV1	1 second forced expiratory volume(%)	12 weeks
Primary	FEV1/FVC ratio	FEV1/FVC ratio expressed as a percentage(%)	12 weeks
Secondary	MEP	maximal expiratory pressure	12 weeks
Secondary	MIP	maximal inspiratory pressure	12 weeks
Secondary	gait performance	6-minute walk test	12 weeks