Inspiratory Muscle Training in Children With Chest Burn

NCT ID: NCT05603507

Last Updated: 2022-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-10

Study Completion Date

2022-05-15

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.

Conditions

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Burns Respiratory Function Impaired Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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inspiratory muscle training group

received both inspiratory muscle training and pulmonary rehabilitation

Group Type EXPERIMENTAL

inspiratory muscle training

Intervention Type OTHER

training done with a pressure threshold-loading device

pulmonary rehabilitation

Intervention Type OTHER

Circuit training of aerobic and resistive exercise

pulmonary rehabilitation group

received only pulmonary rehabilitation and sham inspiratory muscle training

Group Type SHAM_COMPARATOR

pulmonary rehabilitation

Intervention Type OTHER

Circuit training of aerobic and resistive exercise

Interventions

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inspiratory muscle training

training done with a pressure threshold-loading device

Intervention Type OTHER

pulmonary rehabilitation

Circuit training of aerobic and resistive exercise

Intervention Type OTHER

Other Intervention Names

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inspiratory resistance Aerobic and resistance training

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.
Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role collaborator

Prince Sattam Bin Abdulaziz University

OTHER

Sponsor Role collaborator

Qassim University

OTHER

Sponsor Role lead

Responsible Party

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Maged Basha

Assistant Professor, College of Medical Rehabilitation, Qassim University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ragab Elnaggar, PhD

Role: STUDY_CHAIR

Prince Sattam Bin Abdulaziz University

Alshimaa Azab, PhD

Role: STUDY_DIRECTOR

Prince Sattam Bin Abdulaziz University

Locations

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Outpatient Clinic of College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University

Al Kharj, Riyadh Region, Saudi Arabia

Site Status

Countries

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Saudi Arabia

References

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Willis CE, Grisbrook TL, Elliott CM, Wood FM, Wallman KE, Reid SL. Pulmonary function, exercise capacity and physical activity participation in adults following burn. Burns. 2011 Dec;37(8):1326-33. doi: 10.1016/j.burns.2011.03.016. Epub 2011 May 6.

Reference Type BACKGROUND
PMID: 21530086 (View on PubMed)

Laszlo G. Standardisation of lung function testing: helpful guidance from the ATS/ERS Task Force. Thorax. 2006 Sep;61(9):744-6. doi: 10.1136/thx.2006.061648.

Reference Type RESULT
PMID: 16936234 (View on PubMed)

Other Identifiers

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RHPT/0020/0082

Identifier Type: -

Identifier Source: org_study_id

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