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Impact of Respiratory Physiotherapy in Children With Bronchiolitis in the First Two Years of Life

Primary Purpose

Bronchiolitis

Status
Recruiting
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Physiotheraphy + Conventional treatment
Conventional treatment
Sponsored by
Aveiro University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiolitis

Eligibility Criteria

undefined - 2 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • medical diagnostic for 1st or 2nd episode of bronchiolitis and were healthy three days before the current diagnosis of bronchiolitis

Exclusion Criteria:

  • 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..

Sites / Locations

  • Faculdade de Desporto da Universidade do PortoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Conventional treatment

Physiotheraphy + Conventional treatment

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Wang severity scale
Classification of severity of respiratory condition by Wang scale through the respiratory rate, presence of wheezing, retractions and overview.

Full Information

First Posted
March 9, 2016
Last Updated
September 28, 2022
Sponsor
Aveiro University
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1. Study Identification

Unique Protocol Identification Number
NCT02708147
Brief Title
Impact of Respiratory Physiotherapy in Children With Bronchiolitis in the First Two Years of Life
Official Title
Impact of Respiratory Physiotherapy in Children With Bronchiolitis in the First Two Years of Life
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 2016 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aveiro University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional treatment
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Physiotheraphy + Conventional treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Physiotheraphy + Conventional treatment
Other Intervention Name(s)
Experimental
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional treatment
Other Intervention Name(s)
Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Computerized lung sounds
Description
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
Time Frame
From the 1st to the 21st day.
Secondary Outcome Measure Information:
Title
Wang severity scale
Description
Classification of severity of respiratory condition by Wang scale through the respiratory rate, presence of wheezing, retractions and overview.
Time Frame
From the 1st to the 21st day.

10. Eligibility

Sex
All
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: medical diagnostic for 1st or 2nd episode of bronchiolitis and were healthy three days before the current diagnosis of bronchiolitis Exclusion Criteria: 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..
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alda S Marques, PhD
Phone
+351234 372 462
Email
amarques@ua.pt
First Name & Middle Initial & Last Name or Official Title & Degree
Veronica L Abreu, MsH
Phone
+351 939465797
Email
veronica.abreu@gaia.ipiaget.pt
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alda M Marques, PhD
Organizational Affiliation
Aveiro University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Veronica L Abreu, MsH
Organizational Affiliation
Universidade do Porto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
José A Duarte, PhD
Organizational Affiliation
Universidade do Porto
Official's Role
Study Chair
Facility Information:
Facility Name
Faculdade de Desporto da Universidade do Porto
City
Porto
ZIP/Postal Code
4200-450
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Veronica L Abreu, MsH
Phone
00351939465797
Email
veronica.abreu@gaia.ipiaget.pt
First Name & Middle Initial & Last Name & Degree
Alda S. Marques, PhD
First Name & Middle Initial & Last Name & Degree
Veronica L Abreu, MsH
First Name & Middle Initial & Last Name & Degree
José A Duarte, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24046460
Citation
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. Erratum In: Respir Care. 2016 Jan;61(1):e1.
Results Reference
background

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Impact of Respiratory Physiotherapy in Children With Bronchiolitis in the First Two Years of Life

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