Inspiratory Muscle Training in Children With Chest Burn

Study Overview
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Brief Summary
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8 weeks of inspiratory muscle training combined with a pulmonary rehabilitation program increases respiratory muscle strength, pulmonary function, functional capacity, and quality of life in chest burned children.

Detailed Description
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The primary purpose of this study is to see how an inspiratory muscle training program along with a pulmonary rehabilitation program improved respiratory muscle strength, respiratory function and quality of life after children with chest burns were discharged from the hospital.

Official Title
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Inspiratory Muscle Training Effects on Pulmonary Function and Quality of Life in Children With Chest Burn

Conditions
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Burns, Respiratory Function Impaired, Children

Intervention / Treatment
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* Other: inspiratory muscle training
* Other: pulmonary rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children aged 10 to 18. Following hospital discharge.- Total body surface area (TBSA) of 30% to 50%. Chest burns. Deep partial to full thickness burns. Subjects who had a skin graft or who healed completely were also included. Exclusion Criteria: - Participants who had a nonhealing or open wound. Congenital diaphragmatic hernia. Chest wall deformity. Cardiac or pulmonary problems.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: inspiratory muscle training group<br>received both inspiratory muscle training and pulmonary rehabilitation | Other: inspiratory muscle training<br>* training done with a pressure threshold-loading device<br>* Other names: inspiratory resistance;Other: pulmonary rehabilitation<br>* Circuit training of aerobic and resistive exercise<br>* Other names: Aerobic and resistance training;|
| Sham Comparator: pulmonary rehabilitation group<br>received only pulmonary rehabilitation and sham inspiratory muscle training | Other: pulmonary rehabilitation<br>* Circuit training of aerobic and resistive exercise<br>* Other names: Aerobic and resistance training;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maximal inspiratory pressure | performed using an electronic respiratory pressure meter | 1 week after hospital discharge | 
| maximal inspiratory pressure | performed using an electronic respiratory pressure meter | 8 weeks | 
| maximal expiratory pressure | performed using an electronic respiratory pressure meter | 1 week after hospital discharge | 
| maximal expiratory pressure | performed using an electronic respiratory pressure meter | 8 weeks | 
| Pulmonary function test, forced expiratory volume in the first second | performed using a spirometer, the FEV1 (forced expiratory volume in the first second) was recorded. | 1 week after hospital discharge | 
| Pulmonary function test, forced expiratory volume in the first second | performed using a spirometer, the FEV1 (forced expiratory volume in the first second) was recorded. | 8 weeks | 
| Pulmonary function test, forced vital capacity | performed using a spirometer, the FVC (forced vital capacity) was recorded. | 1 week after hospital discharge | 
| Pulmonary function test, forced vital capacity | performed using a spirometer, the FVC (forced vital capacity) was recorded. | 8 weeks | 
| Pulmonary function test, FEV1/FVC ratio | performed using a spirometer, (forced expiratory volume in the first second/ forced vital capacity) FEV1/FVC ratio was recorded. | 1 week after hospital discharge | 
| Pulmonary function test, FEV1/FVC ratio | performed using a spirometer, (forced expiratory volume in the first second/ forced vital capacity) FEV1/FVC ratio was recorded. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional exercise capacity | assessed using the six-minute walk test | 1 week after hospital discharge | 
| Functional exercise capacity | assessed using the six-minute walk test | 8 weeks | 
| Health related Quality of Life | assessed using the validated cross-culturally adapted version of the Pediatric Quality of life, The Peds-QL is a 23-item scale. Participants scored on a 5-point Likert scale ranging from 0 (never an issue) to 4 (almost always a problem). Following that, the item scores are decoded and linearly transformed to a 100-point scale. The psychosocial functioning summary score and physical functioning summary score were used for this study. A score of 100 indicates the highest functional status, while a score of 0 indicates the lowest functional status. | 1 week after hospital discharge | 
| Health related Quality of Life | assessed using the validated cross-culturally adapted version of the Pediatric Quality of life, The Peds-QL is a 23-item scale. Participants scored on a 5-point Likert scale ranging from 0 (never an issue) to 4 (almost always a problem). Following that, the item scores are decoded and linearly transformed to a 100-point scale. The psychosocial functioning summary score and physical functioning summary score were used for this study. A score of 100 indicates the highest functional status, while a score of 0 indicates the lowest functional status. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chest burn, respiratory muscle strength, lung function