Inspiratory Muscle Training in Children With Chest Burn

NCT05603507 | Completed

• 1 other identifier: RHPT/0020/0082
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Burns; Respiratory Function Impaired; Children

Keywords

chest burn; respiratory muscle strength; lung function

Outcome Measures

Primary Outcomes (10)

• maximal inspiratory pressure

  performed using an electronic respiratory pressure meter

  1 week after hospital discharge

• maximal inspiratory pressure

  performed using an electronic respiratory pressure meter

  8 weeks

• maximal expiratory pressure

  performed using an electronic respiratory pressure meter

  1 week after hospital discharge

• maximal expiratory pressure

  performed using an electronic respiratory pressure meter

  8 weeks

• 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

• 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

• Pulmonary function test, forced vital capacity

  performed using a spirometer, the FVC (forced vital capacity) was recorded.

  1 week after hospital discharge

• Pulmonary function test, forced vital capacity

  performed using a spirometer, the FVC (forced vital capacity) was recorded.

  8 weeks

• 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

• 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 Outcomes (4)

• Functional exercise capacity

  1 week after hospital discharge

• Functional exercise capacity

  8 weeks

• Health related Quality of Life

  1 week after hospital discharge

• Health related Quality of Life

  8 weeks

Study Arms (2)

inspiratory muscle training group

EXPERIMENTAL

received both inspiratory muscle training and pulmonary rehabilitation

Other: inspiratory muscle training; Other: pulmonary rehabilitation

pulmonary rehabilitation group

SHAM COMPARATOR

received only pulmonary rehabilitation and sham inspiratory muscle training

Other: pulmonary rehabilitation

Interventions

inspiratory muscle training OTHER

training done with a pressure threshold-loading device

Also known as: inspiratory resistance

inspiratory muscle training group

pulmonary rehabilitation OTHER

Circuit training of aerobic and resistive exercise

Also known as: Aerobic and resistance training

inspiratory muscle training group; pulmonary rehabilitation group

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• \- Participants who had a nonhealing or open wound.
• Congenital diaphragmatic hernia.
• Chest wall deformity.
• Cardiac or pulmonary problems.

Sponsors & Collaborators

• Qassim University: lead
• Cairo University: collaborator
• Prince Sattam Bin Abdulaziz University: collaborator

Study Sites (1)

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

Al Kharj, Riyadh Region, 11432, Saudi Arabia

Location

Related Publications (2)

• 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.

  PMID: 21530086 BACKGROUND

• 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.

  PMID: 16936234 RESULT

MeSH Terms

Conditions

Burns; Respiratory Insufficiency

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Wounds and Injuries; Respiration Disorders; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ragab Elnaggar, PhD

  Prince Sattam Bin Abdulaziz University

  STUDY CHAIR

• Alshimaa Azab, PhD

  Prince Sattam Bin Abdulaziz University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, College of Medical Rehabilitation, Qassim University

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: November 2, 2022
• Study Start: September 10, 2021
• Primary Completion: April 9, 2022
• Study Completion: May 15, 2022
• Last Updated: November 2, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 6 months after publication
• Access Criteria: relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.

Locations

SA (1)