Try our beta test site

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2016 by Aveiro University
Sponsor:
Information provided by (Responsible Party):
Alda Sofia Pires de Dias Marques, Aveiro University
ClinicalTrials.gov Identifier:
NCT02708147
First received: March 9, 2016
Last updated: March 11, 2016
Last verified: March 2016
  Purpose

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.


Condition Intervention
Bronchiolitis
Other: Physioteraphy + Conventional treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Impact of Respiratory Physiotherapy in Children With Bronchiolitis in the First Two Years of Life

Further study details as provided by Aveiro University:

Primary Outcome Measures:
  • Computorized 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


Secondary Outcome Measures:
  • Wang severity scale [ Time Frame: From the 1st to the 21st day. ]
    Classification of severity of respiratory condition by Wang scale through the respiratory rate, presence of wheezing, retractions and overview.


Estimated Enrollment: 52
Study Start Date: September 2016
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Conventional treatment
Only evaluations will be made at baseline and on the 3th, 5th and 21st days and an interview 30 days after.
Experimental: Physioteraphy + 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.
Other: Physioteraphy + Conventional treatment
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.

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.

  Eligibility

Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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..
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02708147

Contacts
Contact: Alda S Marques, PhD +351234 372 462 amarques@ua.pt
Contact: Veronica L Abreu, MsH +351 939465797 veronica.abreu@gaia.ipiaget.pt

Sponsors and Collaborators
Aveiro University
Investigators
Principal Investigator: Alda M Marques, PhD Aveiro University
  More Information

Publications:
Responsible Party: Alda Sofia Pires de Dias Marques, Senior Lecturer, Aveiro University
ClinicalTrials.gov Identifier: NCT02708147     History of Changes
Other Study ID Numbers: PhDPT/VeronicaAbreu/2016
Study First Received: March 9, 2016
Last Updated: March 11, 2016
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on March 28, 2017