NCT04125108

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

October 10, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 14, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2020

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2020

Completed
Last Updated

February 10, 2020

Status Verified

October 1, 2019

Enrollment Period

3 months

First QC Date

October 10, 2019

Last Update Submit

February 6, 2020

Conditions

Inhalation InjuryPulmonary Disease

Keywords

burnPulmonary Function TestPulmonary Rehabilitation

Outcome Measures

Primary Outcomes (3)

  • FVC

    forced vital capacity(%)

    12 weeks

  • FEV1

    1 second forced expiratory volume(%)

    12 weeks

  • FEV1/FVC ratio

    FEV1/FVC ratio expressed as a percentage(%)

    12 weeks

Secondary Outcomes (3)

  • MEP

    12 weeks

  • MIP

    12 weeks

  • gait performance

    12 weeks

Study Arms (2)

pulmonary rehabilitation group

EXPERIMENTAL

The experimental group was to participate in a 12-week pulmonary rehabilitation program supplemented with an individualized and supervised exercise-training program.

Other: pulmonary rehabilitation

control group

NO INTERVENTION

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

Interventions

pulmonary rehabilitationOTHER

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.

pulmonary rehabilitation group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • inhalation injury
  • The burn surface area of chest and neck are more than 50% of the anterior or posterior trunk areas.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hangang Sacred Heart Hospital

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

Location

Related 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.0b013e3181db5317.

    PMID: 20354445RESULT

  • 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.

    PMID: 31504621RESULT

MeSH Terms

Conditions

Lung DiseasesBurns

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2019

First Posted

October 14, 2019

Study Start

October 10, 2019

Primary Completion

January 10, 2020

Study Completion

January 30, 2020

Last Updated

February 10, 2020

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)