Bronchial AsthmaNCT05212558
Coupled Inspiratory and Expiratory Muscle Training in Children With Bronchial Asthma
A study testing Inspiratory muscle training and Combined inspiratory and expiratory muscle training in people with Bronchial Asthma, run by Cairo University at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Bronchial Asthma
- What is being tested?
- Inspiratory muscle training and Combined inspiratory and expiratory muscle training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 2 Aug 2020to 28 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Unstable asthma
- Exacerbation of asthma symptoms
- History of thoracic surgery
- Cognitive/behavioral problems
- Cardiopulmonary co-morbidities
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Bronchial Asthma
- Being tested
- Placebo respiratory muscle training, Inspiratory muscle training, Combined inspiratory and expiratory muscle training
- Keywords
- Chronic Respiratory Diseases, Respiratory Therapy, Chest Physiotherapy, Pulmonary Functions, Asthma, Respiratory Muscle Training
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo respiratory muscle trainingOther
Unloaded respiratory muscle training plus conventional respiratory exercises
Inspiratory muscle trainingOther
Inspiratory muscle training plus conventional respiratory exercises
Combined inspiratory and expiratory muscle trainingOther
Combined inspiratory and expiratory muscle training in the same respiratory cycle plus conventional respiratory exercises.
| Study group | Role | What they receive |
|---|---|---|
| Placebo group | Placebo comparator | This group received a conventional respiratory retraining program plus unloaded (placebo) respiratory muscle training Receives: Other: Placebo respiratory muscle training |
| Inspiratory muscle training group | Active comparator | This group received a conventional respiratory retraining program plus inspiratory muscle training only Receives: 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. Receives: Other: Combined inspiratory and expiratory muscle training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 months
Secondary outcomes (1)
Asthma symptoms
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).
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start2 Aug 2020
- Primary completion28 Oct 2021
- Study completion28 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchial AsthmaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- A randomized, placebo-controlled, assessor-blinded clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ragab Kamal Elnaggar, Cairo University
- Investigators
- Ragab K Elnaggar, PhD, Principal investigator, Prince Sattam Bin Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05212558
- Sponsor's protocol ID
- RHPT/0020/0061
- Status last verified
- Jan 2022
- First submitted
- 3 Jan 2022
- Last updated
- 28 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05212558
- Acronym / sponsor ID
- RHPT/0020/0061
- Conditions
- Bronchial Asthma
- Keywords
- Chronic Respiratory Diseases, Respiratory Therapy, Chest Physiotherapy, Pulmonary Functions, Asthma, Respiratory Muscle Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 2 Aug 2020 (actual)
- Primary completion
- 28 Oct 2021 (actual)
- Study completion
- 28 Oct 2021 (actual)
- First posted
- 28 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- A randomized, placebo-controlled, assessor-blinded clinical trial
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Other: Placebo respiratory muscle trainingThis group received a conventional respiratory retraining program plus unloaded (placebo) respiratory muscle training |
| Inspiratory muscle training group | Active comparator | Other: Inspiratory muscle trainingThis group received a conventional respiratory retraining program plus inspiratory muscle training only |
| Combined training group | Experimental | Other: Combined inspiratory and expiratory muscle trainingThis group received a conventional respiratory retraining program plus inspiratory and expiratory muscle training in the same respiratory cycle. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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%
Key exclusion criteria (5 listed)
- Unstable asthma
- Exacerbation of asthma symptoms
- History of thoracic surgery
- Cognitive/behavioral problems
- Cardiopulmonary co-morbidities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo respiratory muscle trainingUnloaded respiratory muscle training plus conventional respiratory exercises | Other | Placebo group |
| Inspiratory muscle trainingInspiratory muscle training plus conventional respiratory exercises | Other | Inspiratory muscle training group |
| Combined inspiratory and expiratory muscle trainingCombined inspiratory and expiratory muscle training in the same respiratory cycle plus conventional respiratory exercises. | Other | Combined training group |
Primary outcome
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.
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.
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.
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.
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.
1 secondary outcome
Asthma symptoms
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ragab K Elnaggar, PhD principal investigator
Prince Sattam Bin Abdulaziz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory muscle training and Combined inspiratory and expiratory muscle training in people with Bronchial Asthma, run by Cairo University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inspiratory muscle strength (time frame: 2 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2022.