Coupled Inspiratory and Expiratory Muscle Training in Children With Bronchial Asthma

Sponsor

Cairo University (Other)

Overall Status

Completed

CT.gov ID

NCT05212558

Collaborator

(none)

Enrollment

Location

Arms

14.9

Actual Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bronchial Asthma	Other: Placebo respiratory muscle training Other: Inspiratory muscle training Other: Combined inspiratory and expiratory muscle training	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

51 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

A randomized, placebo-controlled, assessor-blinded clinical trialA randomized, placebo-controlled, assessor-blinded clinical trial

Masking:

Single (Outcomes Assessor)

Masking Description:

The outcome assessor was blinded to the treatment allocation

Primary Purpose:

Treatment

Official 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

Actual Study Start Date :

Aug 2, 2020

Actual Primary Completion Date :

Oct 28, 2021

Actual Study Completion Date :

Oct 28, 2021

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo group This group received a conventional respiratory retraining program plus unloaded (placebo) respiratory muscle training	Other: Placebo respiratory muscle training Unloaded respiratory muscle training plus conventional respiratory exercises
Active Comparator: Inspiratory muscle training group This group received a conventional respiratory retraining program plus inspiratory muscle training only	Other: Inspiratory muscle training Inspiratory muscle training plus conventional respiratory exercises
Experimental: Combined training group 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 Combined inspiratory and expiratory muscle training in the same respiratory cycle plus conventional respiratory exercises.

Arm

Intervention/Treatment

Placebo Comparator: Placebo group

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

Other: Placebo respiratory muscle training

Unloaded respiratory muscle training plus conventional respiratory exercises

Active Comparator: Inspiratory muscle training group

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

Other: Inspiratory muscle training

Inspiratory muscle training plus conventional respiratory exercises

Experimental: Combined training group

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

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

Outcome Measures

Primary Outcome Measures

Inspiratory muscle strength [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.
Expiratory muscle strength [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.
Forced vital capacity [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.
Forced expiratory volume in one second [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.
Forced expiratory volume in one second / forced vital capacity [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 Outcome Measures

Asthma symptoms [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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