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Inspiratory Muscle Training in Children With Chest Burn (chestburn)

Primary Purpose

Burns, Respiratory Function Impaired, Children

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
inspiratory muscle training
pulmonary rehabilitation
Sponsored by
Qassim University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burns focused on measuring chest burn, respiratory muscle strength, lung function

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

inspiratory muscle training group

pulmonary rehabilitation group

Arm Description

received both inspiratory muscle training and pulmonary rehabilitation

received only pulmonary rehabilitation and sham inspiratory muscle training

Outcomes

Primary Outcome Measures

maximal inspiratory pressure
performed using an electronic respiratory pressure meter
maximal inspiratory pressure
performed using an electronic respiratory pressure meter
maximal expiratory pressure
performed using an electronic respiratory pressure meter
maximal expiratory pressure
performed using an electronic respiratory pressure meter
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.
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.
Pulmonary function test, forced vital capacity
performed using a spirometer, the FVC (forced vital capacity) was recorded.
Pulmonary function test, forced vital capacity
performed using a spirometer, the FVC (forced vital capacity) was recorded.
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.
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.

Secondary Outcome Measures

Functional exercise capacity
assessed using the six-minute walk test
Functional exercise capacity
assessed using the six-minute walk test
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.
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.

Full Information

First Posted
October 26, 2022
Last Updated
October 28, 2022
Sponsor
Qassim University
Collaborators
Cairo University, Prince Sattam Bin Abdulaziz University
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1. Study Identification

Unique Protocol Identification Number
NCT05603507
Brief Title
Inspiratory Muscle Training in Children With Chest Burn
Acronym
chestburn
Official Title
Inspiratory Muscle Training Effects on Pulmonary Function and Quality of Life in Children With Chest Burn
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
September 10, 2021 (Actual)
Primary Completion Date
April 9, 2022 (Actual)
Study Completion Date
May 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qassim University
Collaborators
Cairo University, Prince Sattam Bin Abdulaziz University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns, Respiratory Function Impaired, Children
Keywords
chest burn, respiratory muscle strength, lung function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
inspiratory muscle training group
Arm Type
Experimental
Arm Description
received both inspiratory muscle training and pulmonary rehabilitation
Arm Title
pulmonary rehabilitation group
Arm Type
Sham Comparator
Arm Description
received only pulmonary rehabilitation and sham inspiratory muscle training
Intervention Type
Other
Intervention Name(s)
inspiratory muscle training
Other Intervention Name(s)
inspiratory resistance
Intervention Description
training done with a pressure threshold-loading device
Intervention Type
Other
Intervention Name(s)
pulmonary rehabilitation
Other Intervention Name(s)
Aerobic and resistance training
Intervention Description
Circuit training of aerobic and resistive exercise
Primary Outcome Measure Information:
Title
maximal inspiratory pressure
Description
performed using an electronic respiratory pressure meter
Time Frame
1 week after hospital discharge
Title
maximal inspiratory pressure
Description
performed using an electronic respiratory pressure meter
Time Frame
8 weeks
Title
maximal expiratory pressure
Description
performed using an electronic respiratory pressure meter
Time Frame
1 week after hospital discharge
Title
maximal expiratory pressure
Description
performed using an electronic respiratory pressure meter
Time Frame
8 weeks
Title
Pulmonary function test, forced expiratory volume in the first second
Description
performed using a spirometer, the FEV1 (forced expiratory volume in the first second) was recorded.
Time Frame
1 week after hospital discharge
Title
Pulmonary function test, forced expiratory volume in the first second
Description
performed using a spirometer, the FEV1 (forced expiratory volume in the first second) was recorded.
Time Frame
8 weeks
Title
Pulmonary function test, forced vital capacity
Description
performed using a spirometer, the FVC (forced vital capacity) was recorded.
Time Frame
1 week after hospital discharge
Title
Pulmonary function test, forced vital capacity
Description
performed using a spirometer, the FVC (forced vital capacity) was recorded.
Time Frame
8 weeks
Title
Pulmonary function test, FEV1/FVC ratio
Description
performed using a spirometer, (forced expiratory volume in the first second/ forced vital capacity) FEV1/FVC ratio was recorded.
Time Frame
1 week after hospital discharge
Title
Pulmonary function test, FEV1/FVC ratio
Description
performed using a spirometer, (forced expiratory volume in the first second/ forced vital capacity) FEV1/FVC ratio was recorded.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Functional exercise capacity
Description
assessed using the six-minute walk test
Time Frame
1 week after hospital discharge
Title
Functional exercise capacity
Description
assessed using the six-minute walk test
Time Frame
8 weeks
Title
Health related Quality of Life
Description
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.
Time Frame
1 week after hospital discharge
Title
Health related Quality of Life
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ragab Elnaggar, PhD
Organizational Affiliation
Prince Sattam Bin Abdulaziz University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Alshimaa Azab, PhD
Organizational Affiliation
Prince Sattam Bin Abdulaziz University
Official's Role
Study Director
Facility Information:
Facility Name
Outpatient Clinic of College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University
City
Al-Kharj
State/Province
Riyadh
ZIP/Postal Code
11432
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
IPD Sharing Time Frame
6 months after publication
IPD Sharing Access Criteria
relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.
Citations:
PubMed Identifier
21530086
Citation
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.
Results Reference
background
PubMed Identifier
16936234
Citation
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.
Results Reference
result

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Inspiratory Muscle Training in Children With Chest Burn

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