Clinical trial NCT05212558: Coupled Inspiratory and Expiratory Muscle Training in Children With Bronchial Asthma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchial Asthma
Keywords: Chronic Respiratory Diseases
Respiratory Therapy
Chest Physiotherapy
Pulmonary Functions
Asthma
Respiratory Muscle Training
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-01-28
Enrollment: 51
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: A randomized, placebo-controlled, assessor-blinded clinical trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Inspiratory muscle strength
timeFrame: 2 months
measure: Expiratory muscle strength
timeFrame: 2 months
measure: Forced vital capacity
timeFrame: 2 months
measure: Forced expiratory volume in one second
timeFrame: 2 months
measure: Forced expiratory volume in one second / forced vital capacity
timeFrame: 2 months
Secondary outcomes:
measure: Asthma symptoms
timeFrame: 2 months
Other outcomes:
Locations:
city: Al Kharj
country: Saudi Arabia
facility: Ragab K. Elnaggar
state: Riyadh
Study officials:
affiliation: Prince Sattam Bin Abdulaziz University
name: Ragab K Elnaggar, PhD
role: PRINCIPAL_INVESTIGATOR
References: