Coupled Inspiratory and Expiratory Muscle Training in Children With Bronchial Asthma

NCT ID: NCT05212558

Last Updated: 2022-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-02
• Study Completion Date: 2021-10-28

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.

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

1. Respiratory muscle strength: assessed by measuring the maximal inspiratory and expiratory pressure using an electronic respiratory pressure meter.

2. 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.

3. 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.

Conditions

Bronchial Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Placebo group

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

Group Type: PLACEBO_COMPARATOR

Placebo respiratory muscle training

Intervention Type: OTHER

Unloaded respiratory muscle training plus conventional respiratory exercises

Inspiratory muscle training group

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

Group Type: ACTIVE_COMPARATOR

Inspiratory muscle training

Intervention Type: OTHER

Inspiratory muscle training plus conventional respiratory exercises

Combined training group

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

Group Type: EXPERIMENTAL

Combined inspiratory and expiratory muscle training

Intervention Type: OTHER

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

Interventions

Placebo respiratory muscle training

Unloaded respiratory muscle training plus conventional respiratory exercises

Intervention Type: OTHER

Inspiratory muscle training

Inspiratory muscle training plus conventional respiratory exercises

Intervention Type: OTHER

Combined inspiratory and expiratory muscle training

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ragab Kamal Elnaggar

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ragab K Elnaggar, PhD

Role: PRINCIPAL_INVESTIGATOR

Prince Sattam Bin Abdulaziz University

Locations

Ragab K. Elnaggar

Al Kharj, Riyadh Region, Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

RHPT/0020/0061

Identifier Type: -

Identifier Source: org_study_id