Clinical trial NCT05603507: Inspiratory Muscle Training in Children With Chest Burn
Official title: Inspiratory Muscle Training Effects on Pulmonary Function and Quality of Life in Children With Chest Burn
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burns
Respiratory Function Impaired
Children
Keywords: chest burn
respiratory muscle strength
lung function
Lead sponsor: Qassim University
Sponsor class: OTHER
Collaborators: name: Cairo University
name: Prince Sattam Bin Abdulaziz University
First posted: 2022-11-02
Enrollment: 40
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: maximal inspiratory pressure
timeFrame: 1 week after hospital discharge
measure: maximal inspiratory pressure
timeFrame: 8 weeks
measure: maximal expiratory pressure
timeFrame: 1 week after hospital discharge
measure: maximal expiratory pressure
timeFrame: 8 weeks
measure: Pulmonary function test, forced expiratory volume in the first second
timeFrame: 1 week after hospital discharge
measure: Pulmonary function test, forced expiratory volume in the first second
timeFrame: 8 weeks
measure: Pulmonary function test, forced vital capacity
timeFrame: 1 week after hospital discharge
measure: Pulmonary function test, forced vital capacity
timeFrame: 8 weeks
measure: Pulmonary function test, FEV1/FVC ratio
timeFrame: 1 week after hospital discharge
measure: Pulmonary function test, FEV1/FVC ratio
timeFrame: 8 weeks
Secondary outcomes:
measure: Functional exercise capacity
timeFrame: 1 week after hospital discharge
measure: Functional exercise capacity
timeFrame: 8 weeks
measure: Health related Quality of Life
timeFrame: 1 week after hospital discharge
measure: Health related Quality of Life
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Al-Kharj
country: Saudi Arabia
facility: Outpatient Clinic of College of Applied Medical Sciences, Prince Sattam bin Abdulaziz University
state: Riyadh
Study officials:
affiliation: Prince Sattam Bin Abdulaziz University
name: Ragab Elnaggar, PhD
role: STUDY_CHAIR
affiliation: Prince Sattam Bin Abdulaziz University
name: Alshimaa Azab, PhD
role: STUDY_DIRECTOR
References:
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.
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.