Impact of Respiratory Physiotherapy in Children With Bronchiolitis in the First Two Years of Life
1 other identifier
interventional
52
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 9, 2016
CompletedFirst Posted
Study publicly available on registry
March 15, 2016
CompletedStudy Start
First participant enrolled
October 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2023
CompletedSeptember 29, 2022
September 1, 2022
6.5 years
March 9, 2016
September 28, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
From the 1st to the 21st day.
Secondary Outcomes (1)
Wang severity scale
From the 1st to the 21st day.
Study Arms (2)
Conventional treatment
SHAM COMPARATORConventional 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
EXPERIMENTALApart 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- medical diagnostic for 1st or 2nd episode of bronchiolitis and were healthy three days before the current diagnosis of bronchiolitis
You may not qualify if:
- 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..
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculdade de Desporto da Universidade do Porto
Porto, 4200-450, Portugal
Related Publications (2)
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.
PMID: 24046460BACKGROUNDRoque-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.
PMID: 37010196DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Alda M Marques, PhD
Aveiro University
- PRINCIPAL INVESTIGATOR
Veronica L Abreu, MsH
Universidade do Porto
- STUDY CHAIR
José A Duarte, PhD
Universidade do Porto
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Lecturer
Study Record Dates
First Submitted
March 9, 2016
First Posted
March 15, 2016
Study Start
October 1, 2016
Primary Completion
April 1, 2023
Study Completion
November 1, 2023
Last Updated
September 29, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share