BronchiolitisNCT02708147
Impact of Respiratory Physiotherapy in Children With Bronchiolitis in the First Two Years of Life
A study testing Physiotheraphy + Conventional treatment and Conventional treatment in people with Bronchiolitis, run by Aveiro University at 1 site in Portugal.
Trial summary
This study aims to evaluate the recovery of children with bronchiolitis with and without physical therapy treatments. The experimental group will receive educational information and 5 sessions of physiotherapy with the same protocol, at home or in physical therapy office. The control group will only be evaluated. Read more about this study
- Who is it for?
- Ages Up to 2 years
- Conditions the study is for
- Bronchiolitis
- What is being tested?
- Physiotheraphy + Conventional treatment and Conventional treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 sitePortugal
- Study dates
- Oct 2016to Nov 2023
- 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 Up to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- medical diagnostic for 1st or 2nd episode of bronchiolitis and were healthy three days before the current diagnosis of bronchiolitis
Who cannot join
- comorbidities that can aggravate the severity of bronchiolitis (such as congenital heart disease, Down syndrome, immunosuppression due to medication or diagnosed disease, cystic fibrosis, among others)
- musculoskeletal disorders (eg, scoliosis) and neurological (eg, cerebral palsy) that can interfere with data collection and analysis..
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Faculdade de Desporto da Universidade do Porto
Porto, 4200-450
Veronica L Abreu, MsH, 00351939465797, veronica.abreu@gaia.ipiaget.pt
Alda S. Marques, PhD
About this study
This study aims to evaluate the recovery of children with bronchiolitis with and without physical therapy treatments.
The experimental group will receive educational information and 5 sessions of physiotherapy with the same protocol, at home or in physical therapy office. The control group will only be evaluated.
Read more
For both the experimental and control groups the lung sounds are recorded and the Wang's respiratory severity scale calculated initially and on the 3th, 5th and 21st days and computorized. After 3 months of the initial contact, there will be an interview by the phone about relapses or other clinical signs of bronchiolitis until then.
It is expected that the children receiving physiotherapy have a better recovery than the control group.
Read the detailed description
Due to different opinions in the literature about the relevance of respiratory physiotherapy in the treatment of bronchiolitis, there is an urgent need to conduct studies with robust methodologies to explore the impact of physical therapy in children with bronchiolitis, especially on non-hospitalized, and to consider the different levels of severity of bronchiolitis.
This study aims to evaluate the recovery of children with bronchiolitis with and without physical therapy treatments primarily through the computerized respiratory sounds. As secondary goals secondary measures will be registered to evaluate and compare treatments, such as the duration and frequency of bronchiolitis until 3 months after the diagnosis.
The plan is to recruit approximately 52 children (until the age of 2) with 1st or 2nd bronchiolitis diagnostic by a pediatrician.
Then, the researcher will contact the legal representative of the participants to provide more detailed information and obtain the consent forms. Patients will then be randomly assigned to the conventional treatment group or the conventional treatment plus respiratory physiotherapy group.
The experimental group will receive 5 physiotherapy sessions at home or in a physical therapy office. The respiratory techniques follow a flowchart wich begins with saline instillation in the nose and nasopharyngeal cleaning techniques. Then to clear the lung slow inspiratory and slow and forced expiratory techniques will be used. The application of vibration is also included on the flowchart. During the sessions, educational information will also be provided.
The baseline evaluation will include sociodemographic, anthropometric and clinical data, the calculation of Wang's score and well as computerized lung auscultation. The lung sounds are recorded on 7 anatomic regions: trachea (sternum node) left and right anterior regions (middle clavicular line over the 2nd intercostal space), left and right lateral regions (axillary line over the 4th / 5th intercostal space), left and right back regions (5 cm from the para-vertebral line and 7 cm under the inferior angle of scapular) for approximately 20 seconds.
With the exception of the sample characterization data to be retrieved only in the first evaluation, all other measures will take place in the remaining three evaluations (3th, 5th and 21st days).
The experimental group will still have a final evaluation (auscultation, vital signs and Wang scale) at the end of each treatment session.
A follow-up evaluation will take place after 3 months with a phone interview regarding questioning the recurrence of bronchiolitis, as well as the current presence of symptoms such as cough, sore throat, nasal obstruction, respiratory noise, difficulty sleeping or feeding At the end of this study are expected better results on the experimental group, based on a robust methodology on the impact of respiratory therapy in children from 0 to 2 years, on the treatment bronchiolitis in order to justify the intervention of physiotherapy in this area and to generate recommendations for clinical practice.
- Conditions
- Bronchiolitis
- Being tested
- Physiotheraphy + Conventional treatment, Conventional treatment
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotheraphy + Conventional treatmentOther
Also called Experimental
The experimental group will receive 5 physiotherapy sessions at home or in a physical therapy office. The respiratory techniques follow a flowchart which begins with saline instillation into the nose and nasopharyngeal cleaning techniques. Then to clear the lung slow inspiratory and slow and forced expiratory techniques will be used. The application of vibration is also included on the flowchart. During the sessions, educational information will also be provided.
Conventional treatmentOther
Also called Control
Medication and observation by a physician/paediatrician. Only evaluations will be made at baseline and on the 3th, 5th and 21st days and an interview 30 days after.
| Study group | Role | What they receive |
|---|---|---|
| Conventional treatment | Sham comparator | Conventional treatment means that there will be only contact with physician/paediatrician and maybe drugs prescription.
Only evaluations will be made at baseline and on the 3th, 5th and 21st days and an interview 30 days after. Receives: Other: Conventional treatment |
| Physiotheraphy + Conventional treatment | Experimental | Apart Conventional treatment a Physiotherapy protocol (techniques and education) will be performed on 5 sessions and evaluations will be made after each session as well as on baseline and on the 3th, 5th and 21st days and an interview 30 days after. Receives: Other: Physiotheraphy + Conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Computerized lung sounds
Adventitious lung sounds are sounds superimposed on the normal respiratory sound. There are continuous (wheezes) and discontinuous (crackles) adventitious sounds. They will indicate the severity and recovery of lung disease
Measured: From the 1st to the 21st day.
Secondary outcomes (1)
Wang severity scale
Classification of severity of respiratory condition by Wang scale through the respiratory rate, presence of wheezing, retractions and overview.
Measured: From the 1st to the 21st day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2016 (estimated)
- Study startOct 2016
- Primary completionApr 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for BronchiolitisStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aveiro University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alda Sofia Pires de Dias Marques, Aveiro University
- Investigators
- Alda M Marques, PhD, Study chair, Aveiro UniversityVeronica L Abreu, MsH, Principal investigator, Universidade do PortoJosé A Duarte, PhD, Study chair, Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02708147
- Sponsor's protocol ID
- PhDPT/VeronicaAbreu/2016
- Status last verified
- Sep 2022
- First submitted
- 9 Mar 2016
- Last updated
- 29 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marques A, Oliveira A, Jacome C. Computerized adventitious respiratory sounds as outcome measures for respiratory therapy: a systematic review. Respir Care. 2014 May;59(5):765-76. doi: 10.4187/respcare.02765. Epub 2013 Sep 17.
PubMed 24046460Roque-Figuls M, Gine-Garriga M, Granados Rugeles C, Perrotta C, Vilaro J. Chest physiotherapy for acute bronchiolitis in paediatric patients between 0 and 24 months old. Cochrane Database Syst Rev. 2023 Apr 3;4(4):CD004873. doi: 10.1002/14651858.CD004873.pub6.
PubMed 37010196
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Respiratory Physiotherapy in Children With Bronchiolitis in the First Two Years of Life
- ClinicalTrials.gov ID
- NCT02708147
- Acronym / sponsor ID
- PhDPT/VeronicaAbreu/2016
- Conditions
- Bronchiolitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Aveiro UniversityUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 15 Mar 2016 (estimated)
- 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 aims to evaluate the recovery of children with bronchiolitis with and without physical therapy treatments.
The experimental group will receive educational information and 5 sessions of physiotherapy with the same protocol, at home or in physical therapy office. The control group will only be evaluated.
For both the experimental and control groups the lung sounds are recorded and the Wang's respiratory severity scale calculated initially and on the 3th, 5th and 21st days and computorized. After 3 months of the initial contact, there will be an interview by the phone about relapses or other clinical signs of bronchiolitis until then.
It is expected that the children receiving physiotherapy have a better recovery than the control group.
Detailed description
Due to different opinions in the literature about the relevance of respiratory physiotherapy in the treatment of bronchiolitis, there is an urgent need to conduct studies with robust methodologies to explore the impact of physical therapy in children with bronchiolitis, especially on non-hospitalized, and to consider the different levels of severity of bronchiolitis.
This study aims to evaluate the recovery of children with bronchiolitis with and without physical therapy treatments primarily through the computerized respiratory sounds. As secondary goals secondary measures will be registered to evaluate and compare treatments, such as the duration and frequency of bronchiolitis until 3 months after the diagnosis.
The plan is to recruit approximately 52 children (until the age of 2) with 1st or 2nd bronchiolitis diagnostic by a pediatrician.
Then, the researcher will contact the legal representative of the participants to provide more detailed information and obtain the consent forms. Patients will then be randomly assigned to the conventional treatment group or the conventional treatment plus respiratory physiotherapy group.
The experimental group will receive 5 physiotherapy sessions at home or in a physical therapy office. The respiratory techniques follow a flowchart wich begins with saline instillation in the nose and nasopharyngeal cleaning techniques. Then to clear the lung slow inspiratory and slow and forced expiratory techniques will be used. The application of vibration is also included on the flowchart. During the sessions, educational information will also be provided.
The baseline evaluation will include sociodemographic, anthropometric and clinical data, the calculation of Wang's score and well as computerized lung auscultation. The lung sounds are recorded on 7 anatomic regions: trachea (sternum node) left and right anterior regions (middle clavicular line over the 2nd intercostal space), left and right lateral regions (axillary line over the 4th / 5th intercostal space), left and right back regions (5 cm from the para-vertebral line and 7 cm under the inferior angle of scapular) for approximately 20 seconds.
With the exception of the sample characterization data to be retrieved only in the first evaluation, all other measures will take place in the remaining three evaluations (3th, 5th and 21st days).
The experimental group will still have a final evaluation (auscultation, vital signs and Wang scale) at the end of each treatment session.
A follow-up evaluation will take place after 3 months with a phone interview regarding questioning the recurrence of bronchiolitis, as well as the current presence of symptoms such as cough, sore throat, nasal obstruction, respiratory noise, difficulty sleeping or feeding At the end of this study are expected better results on the experimental group, based on a robust methodology on the impact of respiratory therapy in children from 0 to 2 years, on the treatment bronchiolitis in order to justify the intervention of physiotherapy in this area and to generate recommendations for clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional treatment | Sham comparator | Other: Conventional treatmentConventional treatment means that there will be only contact with physician/paediatrician and maybe drugs prescription. Only evaluations will be made at baseline and on the 3th, 5th and 21st days and an interview 30 days after. |
| Physiotheraphy + Conventional treatment | Experimental | Other: Physiotheraphy + Conventional treatmentApart Conventional treatment a Physiotherapy protocol (techniques and education) will be performed on 5 sessions and evaluations will be made after each session as well as on baseline and on the 3th, 5th and 21st days and an interview 30 days after. |
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- medical diagnostic for 1st or 2nd episode of bronchiolitis and were healthy three days before the current diagnosis of bronchiolitis
Key exclusion criteria (2 listed)
- comorbidities that can aggravate the severity of bronchiolitis (such as congenital heart disease, Down syndrome, immunosuppression due to medication or diagnosed disease, cystic fibrosis, among others)
- musculoskeletal disorders (eg, scoliosis) and neurological (eg, cerebral palsy) that can interfere with data collection and analysis..
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 |
|---|---|---|
| Physiotheraphy + Conventional treatmentAlso: ExperimentalThe experimental group will receive 5 physiotherapy sessions at home or in a physical therapy office. The respiratory techniques follow a flowchart which begins with saline instillation into the nose and nasopharyngeal cleaning techniques. Then to clear the lung slow inspiratory and slow and forced expiratory techniques will be used. The application of vibration is also included on the flowchart. During the sessions, educational information will also be provided. | Other | Physiotheraphy + Conventional treatment |
| Conventional treatmentAlso: ControlMedication and observation by a physician/paediatrician. Only evaluations will be made at baseline and on the 3th, 5th and 21st days and an interview 30 days after. | Other | Conventional treatment |
Primary outcome
Computerized lung sounds
Time frame: From the 1st to the 21st day.
Adventitious lung sounds are sounds superimposed on the normal respiratory sound. There are continuous (wheezes) and discontinuous (crackles) adventitious sounds. They will indicate the severity and recovery of lung disease
1 secondary outcome
Wang severity scale
Time frame: From the 1st to the 21st day.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
- Background: PubMed 24046460Marques A, Oliveira A, Jacome C. Computerized adventitious respiratory sounds as outcome measures for respiratory therapy: a systematic review. Respir Care. 2014 May;59(5):765-76. doi: 10.4187/respcare.02765. Epub 2013 Sep 17.
- Derived from this study: PubMed 37010196Roque-Figuls M, Gine-Garriga M, Granados Rugeles C, Perrotta C, Vilaro J. Chest physiotherapy for acute bronchiolitis in paediatric patients between 0 and 24 months old. Cochrane Database Syst Rev. 2023 Apr 3;4(4):CD004873. doi: 10.1002/14651858.CD004873.pub6.
- 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.
Alda M Marques, PhD study chair
Aveiro University
Veronica L Abreu, MsH principal investigator
Universidade do Porto
José A Duarte, PhD study chair
Universidade do Porto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotheraphy + Conventional treatment and Conventional treatment in people with Bronchiolitis, run by Aveiro University at 1 site in Portugal.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 29 Sep 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 Portugal. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alda S Marques, PhD (+351234 372 462, amarques@ua.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Computerized lung sounds (time frame: From the 1st to the 21st day.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02708147, which also lists 2 linked publications.
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 29 Sep 2022.