Inspiratory Muscle Training in Children With Chest Burn

Not Applicable

Completed

• Conditions: Burns; Respiratory Function Impaired; Children
• Interventions: Other: pulmonary rehabilitation; Other: inspiratory muscle training

• Registration Number: NCT05603507
• Lead Sponsor: Qassim University

Brief Summary

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

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.

Study Timeline

• Study Start: 2021-09-10
• Primary Completion: 2022-04-09
• Study Completion: 2022-05-15
• Status Verified: 2022-10
• Study First Submitted: 2022-10-26
• Study First Submitted QC: 2022-10-28
• Last Update Submitted: 2022-10-28
• Study First Posted: 2022-11-02
• Last Update Posted: 2022-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pulmonary rehabilitation group	pulmonary rehabilitation	received only pulmonary rehabilitation and sham inspiratory muscle training
inspiratory muscle training group	inspiratory muscle training	received both inspiratory muscle training and pulmonary rehabilitation
inspiratory muscle training group	pulmonary rehabilitation	received both inspiratory muscle training and pulmonary rehabilitation

Primary Outcome Measures

Name	Time	Method
Pulmonary function test, FEV1/FVC ratio	8 weeks	performed using a spirometer, (forced expiratory volume in the first second/ forced vital capacity) FEV1/FVC ratio was recorded.
maximal inspiratory pressure	8 weeks	performed using an electronic respiratory pressure meter
maximal expiratory pressure	8 weeks	performed using an electronic respiratory pressure meter
Pulmonary function test, forced expiratory volume in the first second	8 weeks	performed using a spirometer, the FEV1 (forced expiratory volume in the first second) was recorded.
Pulmonary function test, forced vital capacity	8 weeks	performed using a spirometer, the FVC (forced vital capacity) was recorded.

Secondary Outcome Measures

Name	Time	Method
Functional exercise capacity	8 weeks	assessed using the six-minute walk test
Health related Quality of Life	8 weeks	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.

Trial Locations

Locations (1)

Outpatient Clinic of College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University; 🇸🇦 Al-Kharj, Riyadh, Saudi Arabia