Coupled Inspiratory and Expiratory Muscle Training in Children With Bronchial Asthma

NCT05212558 | Completed

• 1 other identifier: RHPT/0020/0061
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bronchial Asthma

Keywords

Chronic Respiratory Diseases; Respiratory Therapy; Chest Physiotherapy; Pulmonary Functions; Asthma; Respiratory Muscle Training

Outcome Measures

Primary Outcomes (5)

• Inspiratory muscle strength

  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 months

• Expiratory muscle strength

  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.

  2 months

• Forced vital capacity

  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.

  2 months

• Forced expiratory volume in one second

  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.

  2 months

• Forced expiratory volume in one second / forced vital capacity

  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.

  2 months

Secondary Outcomes (1)

• Asthma symptoms

  2 months

Study Arms (3)

Placebo group

PLACEBO COMPARATOR

This group received a conventional respiratory retraining program plus unloaded (placebo) respiratory muscle training

Other: Placebo respiratory muscle training

Inspiratory muscle training group

ACTIVE COMPARATOR

This group received a conventional respiratory retraining program plus inspiratory muscle training only

Other: Inspiratory muscle training

Combined training group

EXPERIMENTAL

This group received a conventional respiratory retraining program plus inspiratory and expiratory muscle training in the same respiratory cycle.

Other: Combined inspiratory and expiratory muscle training

Interventions

Placebo respiratory muscle training OTHER

Unloaded respiratory muscle training plus conventional respiratory exercises

Placebo group

Inspiratory muscle training OTHER

Inspiratory muscle training plus conventional respiratory exercises

Inspiratory muscle training group

Combined inspiratory and expiratory muscle training OTHER

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

Combined training group

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Ragab K. Elnaggar

Al Kharj, Riyadh Region, Saudi Arabia

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

• Ragab K Elnaggar, PhD

  Prince Sattam Bin Abdulaziz University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor was blinded to the treatment allocation
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: A randomized, placebo-controlled, assessor-blinded clinical trial

Study Record Dates

• First Submitted: January 3, 2022
• First Posted: January 28, 2022
• Study Start: August 2, 2020
• Primary Completion: October 28, 2021
• Study Completion: October 28, 2021
• Last Updated: January 28, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)