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NCT Number: NCT05212558

Coupled Inspiratory and Expiratory Muscle Training in Children With Bronchial Asthma

This study was designed to assess the effect of inspiratory and expiratory muscle training in the same cycle on respiratory muscle strength, pulmonary functions, perception of asthma symptoms in children with bronchial asthma. Fifty-one children with bronchial asthma were randomly allocated to the unloaded respiratory muscle training (Placebo training group; n = 17), inspiratory muscle training alone (inspiratory muscle training group; n = 17), or combined inspiratory and expiratory muscle training in the same cycle (combined training group; n = 17). All groups were assessed for respiratory muscle strength, pulmonary functions, and asthma symptoms.

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Key information

Conditions

Bronchial Asthma Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ragab K. Elnaggar

Al Kharj, Riyadh Region, Saudi Arabia

About this study

Fifty-one children with bronchial asthma were recruited from King Khalid Hospital, Al-Kharj, Saudi Arabia. The study included children who had a confirmed diagnosis of bronchial asthma according to the Global Initiative for Asthma guidelines, aged 12-18 years, identified as being stable cases, had a baseline percent-predicted value of the peak expiratory flow rate of 60-80%, sustained stale doses of medications in the past three months. Children who had unstable asthma or exacerbated asthma symptoms, history of thoracic surgery, or cardiopulmonary comorbidities were excluded.

Outcome measures

  • Respiratory muscle strength: assessed by measuring the maximal inspiratory and expiratory pressure using an electronic respiratory pressure meter.
  • Pulmonary function: The forced vital capacity (FVC), forced expiratory volume in the first second of expiration (FEV1), and FEV1/FVC ratio, were measured in a pulmonary function test through a spirometry analyzer.
  • Control of asthma symptoms: Asthma symptoms were assessed using a translated version of the asthma control test.

All groups received the conventional respiratory re-training program, three times a week, for 12 weeks in succession. The placebo group additionally received unloaded respiratory muscle training, the inspiratory muscle training group received respiratory muscle training alone, and the combined group received combined inspiratory and expiratory muscle training in the same cycle. Interventions were conducted by a licensed physical therapist who had experience of more than 10 years of respiratory training.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Confirmed diagnosis of asthma according to Global Initiative of Asthma guidelines.
  • Age between 12 and 18 years.
  • Clinically stable asthma.
  • Stable doses of medications in the last three months
  • A percent-predicted value of the peak expiratory flow rate of 60-80%
  • No activity limitation due to asthma

Exclusion criteria

  • Unstable asthma
  • Exacerbation of asthma symptoms
  • History of thoracic surgery
  • Cognitive/behavioral problems
  • Cardiopulmonary co-morbidities

Treatment and study plan

Placebo respiratory muscle training

Other

Unloaded respiratory muscle training plus conventional respiratory exercises

Inspiratory Muscle Training

Other

Inspiratory muscle training plus conventional respiratory exercises

Combined inspiratory and expiratory muscle training

Other

Combined inspiratory and expiratory muscle training in the same respiratory cycle plus conventional respiratory exercises.

Primary outcomes

  1. Inspiratory muscle strength

    Time frame: 2 months

    Inspiratory muscle strength was assessed by measuring the maximal inspiratory pressure (reflects the strength of the diaphragm and other inspiratory muscles) using an electronic respiratory pressure meter, according to the American Thoracic Society and European Respiratory Society standards. The highest value of three acceptable trials was documented and used for the subsequent analysis. The percent predicted maximal inspiratory pressure values (%) were calculated and used for statistical analysis.

  2. Expiratory muscle strength

    Time frame: 2 months

    Expiratory muscle strength was assessed by measuring the maximal expiratory pressure (reflects the strength of the abdominal muscles and other expiratory muscles) using an electronic respiratory pressure meter, according to the American Thoracic Society and European Respiratory Society standards. The highest value of three acceptable trials was documented and used for the subsequent analysis. The percent predicted maximal inspiratory pressure values (%) were calculated and used for statistical analysis.

  3. Forced vital capacity

    Time frame: 2 months

    Forced vital capacity, which is the amount of air that each participant was able to forcibly exhale from his/her lungs after taking the deepest breath they can, was measured in a pulmonary function test with a spirometry analyzer and expressed as a percentage of predicted values (%). Three trials were allowed and the best results were recorded.

  4. Forced expiratory volume in one second

    Time frame: 2 months

    Forced expiratory volume in one second, which is the volume of air exhaled in the first second during forced exhalation after a maximal inspiration, was measured in a pulmonary function test with a spirometry analyzer and expressed as a percentage of predicted values (%). Three trials were allowed and the best results were recorded.

  5. Forced expiratory volume in one second / forced vital capacity

    Time frame: 2 months

    Forced expiratory volume in one second / forced vital capacity, is the ratio of the forced expiratory volume in the first one second to the forced vital capacity of the lungs.

Secondary outcomes

  1. Asthma symptoms

    Time frame: 2 months

    A translated version of the asthma control test was used to assess the degree of control over asthma symptoms. The test is patient-administered consists of 5 items. Each item has five possible responses (1: not controlled and 5: completely controlled). the test score ranges from 5 (inadequate control) to 25 (optimal control).

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

The Rationale of Applying Inspiratory/Expiratory Muscle Training Within the Same Respiratory Cycle in Children With Bronchial Asthma: A Placebo-controlled Randomized Clinical Trial

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 28, 2022
Registry last updated
Jan 28, 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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