Inspiratory Muscle Training in Children With Chest Burn

Burns Clinical Trial

— chestburn  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05603507
• Other study ID #: RHPT/0020/0082
• Status: Completed
• Phase: N/A
• Start date: September 10, 2021
• Est. completion date: May 15, 2022

Study information

• Verified date: October 2022
• Source: Qassim University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 15, 2022
• Est. primary completion date: April 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Burns
• Children
• Respiratory Function Impaired
• Respiratory Insufficiency

Intervention

Other:
• inspiratory muscle training
training done with a pressure threshold-loading device
• pulmonary rehabilitation
Circuit training of aerobic and resistive exercise

Locations

Country	Name	City	State
Saudi Arabia	Outpatient Clinic of College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University	Al-Kharj	Riyadh

Sponsors (3)

Lead Sponsor	Collaborator
Qassim University	Cairo University, Prince Sattam Bin Abdulaziz University

Country where clinical trial is conducted

Saudi Arabia, 

References & Publications (2)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	maximal inspiratory pressure	performed using an electronic respiratory pressure meter	1 week after hospital discharge
Primary	maximal inspiratory pressure	performed using an electronic respiratory pressure meter	8 weeks
Primary	maximal expiratory pressure	performed using an electronic respiratory pressure meter	1 week after hospital discharge
Primary	maximal expiratory pressure	performed using an electronic respiratory pressure meter	8 weeks
Primary	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
Primary	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
Primary	Pulmonary function test, forced vital capacity	performed using a spirometer, the FVC (forced vital capacity) was recorded.	1 week after hospital discharge
Primary	Pulmonary function test, forced vital capacity	performed using a spirometer, the FVC (forced vital capacity) was recorded.	8 weeks
Primary	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
Primary	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	Functional exercise capacity	assessed using the six-minute walk test	1 week after hospital discharge
Secondary	Functional exercise capacity	assessed using the six-minute walk test	8 weeks
Secondary	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
Secondary	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