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Completed

NCT Number: NCT05603507

Inspiratory Muscle Training in Children With Chest Burn

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.

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Key information

Conditions

Burns Children Respiration Disorders Respiratory Function Impaired Respiratory Insufficiency Respiratory Tract Diseases Wounds and Injuries

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Al Kharj, Riyadh Region, 11432, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Inspiratory Muscle Training

Other

training done with a pressure threshold-loading device

Other names: inspiratory resistance

Pulmonary Rehabilitation

Other

Circuit training of aerobic and resistive exercise

Other names: Aerobic and resistance training

Primary outcomes

  1. maximal inspiratory pressure

    Time frame: 1 week after hospital discharge

    performed using an electronic respiratory pressure meter

  2. maximal inspiratory pressure

    Time frame: 8 weeks

    performed using an electronic respiratory pressure meter

  3. maximal expiratory pressure

    Time frame: 1 week after hospital discharge

    performed using an electronic respiratory pressure meter

  4. maximal expiratory pressure

    Time frame: 8 weeks

    performed using an electronic respiratory pressure meter

  5. Pulmonary function test, forced expiratory volume in the first second

    Time frame: 1 week after hospital discharge

    performed using a spirometer, the FEV1 (forced expiratory volume in the first second) was recorded.

  6. Pulmonary function test, forced expiratory volume in the first second

    Time frame: 8 weeks

    performed using a spirometer, the FEV1 (forced expiratory volume in the first second) was recorded.

  7. Pulmonary function test, forced vital capacity

    Time frame: 1 week after hospital discharge

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

  8. Pulmonary function test, forced vital capacity

    Time frame: 8 weeks

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

  9. Pulmonary function test, FEV1/FVC ratio

    Time frame: 1 week after hospital discharge

    performed using a spirometer, (forced expiratory volume in the first second/ forced vital capacity) FEV1/FVC ratio was recorded.

  10. Pulmonary function test, FEV1/FVC ratio

    Time frame: 8 weeks

    performed using a spirometer, (forced expiratory volume in the first second/ forced vital capacity) FEV1/FVC ratio was recorded.

Secondary outcomes

  1. Functional exercise capacity

    Time frame: 1 week after hospital discharge

    assessed using the six-minute walk test

  2. Functional exercise capacity

    Time frame: 8 weeks

    assessed using the six-minute walk test

  3. Health related Quality of Life

    Time frame: 1 week after hospital discharge

    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.

  4. Health related Quality of Life

    Time frame: 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

Qassim University

Other

Collaborators

  • Cairo University
  • Prince Sattam Bin Abdulaziz University

Registry information

Official study title

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

Acronym: chestburn

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 2, 2022
Registry last updated
Nov 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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