search
Back to results

Chest Physiotherapy in Bronchiolitis

Primary Purpose

Bronchiolitis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Chest physiotherapy
Sponsored by
Universidade do Porto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiolitis focused on measuring bronchiolitis, chest physiotherapy, children

Eligibility Criteria

15 Days - 24 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children up to 2 years of age, both genders, with a diagnosis of acute bronchiolitis

Exclusion Criteria:

  • presence of comorbidities, such as cystic fibrosis, neuromuscular, congenital heart disease, prematurity or respiratory distress and all the cases that were admitted into the hospital

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Control

    Intervention

    Arm Description

    The participants just received standard medical treatment

    The participants received medical treatment and chest physiotherapy sessions

    Outcomes

    Primary Outcome Measures

    Reduction of Kristjansson Respiratory Score
    Verified by changes in the Kristjansson Respiratory Score, which is a practical and simple score, that assesses the main signs and symptoms of bronchiolitis, having a good validity and inter-observer reliability.It assigns a value between 0 and 2 to each of the five variables: respiratory rate, chest recession, breath sound, skin colour and general condition. A higher Kristjansson respiratory score indicate a worse respiratory condition.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 6, 2020
    Last Updated
    February 6, 2020
    Sponsor
    Universidade do Porto
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04260919
    Brief Title
    Chest Physiotherapy in Bronchiolitis
    Official Title
    Chest Physiotherapy in Light and Moderate Bronchiolitis in Ambulatory Children Under Two Years of Age - a Randomised Control Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2010 (Actual)
    Primary Completion Date
    March 2011 (Actual)
    Study Completion Date
    March 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidade do Porto

    4. Oversight

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

    5. Study Description

    Brief Summary
    Randomized trial of chest physiotherapy in outpatients with bronchiolitis under two years of age, during two consecutive seasonal outbreaks.
    Detailed Description
    A randomized controlled trial was conducted (following CONSORT Statement) in the Paediatric Emergency Department of Centro Hospitalar Universitário São João-Porto (CHUSJ), a tertiary care hospital, during the period from December to March in 2011 and 2012. Ethical approval was obtained from the Ethics Committee of Centro Hospitalar Universitário São João-Porto. Children up to 2 years of age, both genders, with a diagnosis of acute bronchiolitis based on clinical findings, including wheezing or wheezing with crackles, respiratory distress and alteration of feeding condition, were signalized by the physician who met them at the emergency room. Then, the main investigator of the study interviewed the caregivers and informed about the aims and procedures of the study, after a formal written consent in accordance with the Declaration of Helsinki was sign by all the caregivers. Severity grade was established with the Kristjansson Respiratory Score which variate from light to severe, being the light to moderate selected to study. Randomization in intervention or control group was made by the method of permuted-blocks. All children were assessed in a calm environment, while awake and not crying, and were submitted to a standard assessment protocol consisting of a clinical demographic data collection by interview of parents and the application of the Kristjansson Respiratory Score. All children underwent the same medical treatment protocol at the pediatric emergency department (PED), consisting in nebulization with medication, during the emergency room episode, and counselled in the subsequent one or two weeks and were followed during two weeks after discharge from PED, being reassessed at the end of the two weeks. Children from Intervention Group (IG) underwent a standard intervention chest physiotherapy protocol performed by a physiotherapist, consisting on the techniques: prolonged slow expiration (PSE), rhinopharyngeal retrograde clearance (RRC) and provoked cough (PC).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bronchiolitis
    Keywords
    bronchiolitis, chest physiotherapy, children

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized trial with two groups.
    Masking
    None (Open Label)
    Masking Description
    One control group and one intervention group, where chest physiotherapy is used.
    Allocation
    Randomized
    Enrollment
    45 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    The participants just received standard medical treatment
    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    The participants received medical treatment and chest physiotherapy sessions
    Intervention Type
    Procedure
    Intervention Name(s)
    Chest physiotherapy
    Primary Outcome Measure Information:
    Title
    Reduction of Kristjansson Respiratory Score
    Description
    Verified by changes in the Kristjansson Respiratory Score, which is a practical and simple score, that assesses the main signs and symptoms of bronchiolitis, having a good validity and inter-observer reliability.It assigns a value between 0 and 2 to each of the five variables: respiratory rate, chest recession, breath sound, skin colour and general condition. A higher Kristjansson respiratory score indicate a worse respiratory condition.
    Time Frame
    Baseline; after two weeks of treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Days
    Maximum Age & Unit of Time
    24 Months
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Children up to 2 years of age, both genders, with a diagnosis of acute bronchiolitis Exclusion Criteria: presence of comorbidities, such as cystic fibrosis, neuromuscular, congenital heart disease, prematurity or respiratory distress and all the cases that were admitted into the hospital

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    34177198
    Citation
    Pinto FR, Alexandrino AS, Correia-Costa L, Azevedo I. Ambulatory chest physiotherapy in mild-to-moderate acute bronchiolitis in children under two years of age - A randomized control trial. Hong Kong Physiother J. 2021 Dec;41(2):99-108. doi: 10.1142/S1013702521500098. Epub 2021 Mar 31.
    Results Reference
    derived
    Links:
    URL
    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3433974/
    Description
    Related Info
    URL
    https://www.ncbi.nlm.nih.gov/pubmed/23287014
    Description
    Related Info

    Learn more about this trial

    Chest Physiotherapy in Bronchiolitis

    We'll reach out to this number within 24 hrs