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Respiratory Physical Therapy on the Cardiac Autonomic Modulation Paediatric Patients

Primary Purpose

Viral Bronchiolitis

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Respiratory physical therapy
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Viral Bronchiolitis focused on measuring respiratory physiotherapy, cardiac autonomic modulation, paediatric patients

Eligibility Criteria

2 Months - 11 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • hospitalized children

Exclusion Criteria:

  • age above 12 months;
  • presence of cardiovascular disease or chronic respiratory disease;
  • prescription of vasoactive drugs or sedatives;
  • invasive mechanical ventilation;
  • children on contact or respiratory isolation.

Sites / Locations

  • University of São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

control group

respiratory disease group

Arm Description

Physiotherapy in the control group were also done at hospital, in dorsal decubitus position at 30-degree elevation, all receiving the same treatment given for the paediatric inpatients, except nasotracheal suction, which was not performed due to ethical reasons.

Respiratory disease group consisting of hospitalized children with acute viral bronchiolitis

Outcomes

Primary Outcome Measures

Heart Rate Variability
The heart rate (HR) was recorded with the children in the dorsal decubitus position at 30-degree elevation during 30 minutes before performing the respiratory physiotherapy using airway clearance techniques (ACTs)

Secondary Outcome Measures

Heart Rate Variability
The heart rate (HR) was recorded with the children in the dorsal decubitus position at 30-degree elevation during 10 minutes after 5 minutes performing the respiratory physiotherapy using airway clearance techniques(ACTs)
Heart Rate Variability
The heart rate (HR) was recorded with the children in the dorsal decubitus position at 30-degree elevation after 5 minutes nasotracheal suction (10-minutes record).
Heart Rate Variability
The heart rate (HR) was recorded with the children in the dorsal decubitus position at 30-degree elevation during 40 minutes after nasotracheal suction (30-minute record).

Full Information

First Posted
May 9, 2011
Last Updated
May 13, 2011
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01354561
Brief Title
Respiratory Physical Therapy on the Cardiac Autonomic Modulation Paediatric Patients
Official Title
Effect of Airway Clearance Therapy on the Cardiac Autonomic Modulation in Hospitalized Paediatric Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The present study investigated the influence of respiratory affections on the heart rate variability (HRV) of paediatric patients. We have hypothesised that respiratory physiotherapy would promote a beneficial effect on the cardiac autonomic modulation. Twenty-four children, who were divided into respiratory disease group (RG) and control (CG) groups, were studied. Analysis of HRV was performed with the RG in the dorsal decubitus position during four different moments: basal record (30 minutes); 5 minutes after respiratory physiotherapy by means of airway clearance techniques (10-minute record); 5 minutes after nasotracheal suction (10-minute record); and 40 minutes after nasotracheal suction (30-minute record). CG group was submitted to the same protocol, except nasotracheal suction, which was not performed due to ethical reasons.
Detailed Description
The study of heart rate variability (HRV) is a method allowing non-invasive and selective evaluation of the changes in cardiac autonomic modulation. Its use in several clinical situations has provided important information, serving as an evaluation instrument for a better understanding of the involvement of the autonomic nervous system in various physiopathological situations. With regard to the applicability of HRV analysis in paediatric populations, it is known that the maturity progression of sympathetic and vagal divisions is accompanied by a growing increase in autonomic modulation over the pre- and post-natal periods. In turn, a few studies have addressed the association between pathological paediatric conditions and changes in the cardiac autonomic modulation, consequently, HRV. Among these pathologies, the respiratory affections are the main factors of morbidity and mortality in children, since newborns have peculiar aspects involving the respiratory system that can easily lead to a lung failure. Within this context, one can note the importance of the respiratory physiotherapy as an intervention using specific procedures in each case in order to decrease the airway resistance and improve the ventilation/perfusion ratio, thus improving the respiratory function and minimising the clinical severity. Consequently, in patients suffering from obstructive pathologies or neuromuscular dysfunctions, which makes cough an inefficient mechanism, physiotherapy can help them to recover from their condition. Therefore, the respiratory physiotherapy has influence on the several hospitalisation phases, contributing to make the hospital stays shorter and less difficult to the paediatric inpatient and promoting a more humanised and more efficient environment based on the patient's needs. In this sense, it is possible that the paediatric inpatients present important alterations in their cardiovascular autonomic control, since constant oscillations in the cardiac and hemodynamic parameters are observed. However, studies correlating HRV with respiratory pathological conditions in paediatric inpatients are rare, either before or after the respiratory physiotherapy procedures, such as application of airway clearance techniques.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Viral Bronchiolitis
Keywords
respiratory physiotherapy, cardiac autonomic modulation, paediatric patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Sham Comparator
Arm Description
Physiotherapy in the control group were also done at hospital, in dorsal decubitus position at 30-degree elevation, all receiving the same treatment given for the paediatric inpatients, except nasotracheal suction, which was not performed due to ethical reasons.
Arm Title
respiratory disease group
Arm Type
Active Comparator
Arm Description
Respiratory disease group consisting of hospitalized children with acute viral bronchiolitis
Intervention Type
Procedure
Intervention Name(s)
Respiratory physical therapy
Other Intervention Name(s)
chest therapy
Intervention Description
Respiratory physical therapy using airway clearance techniques was conducted by a physiotherapist according to a detailed clinical evaluation of each patient, consisting of thoracic percussion, manual vibration, postural drainage, and cough stimulation.
Primary Outcome Measure Information:
Title
Heart Rate Variability
Description
The heart rate (HR) was recorded with the children in the dorsal decubitus position at 30-degree elevation during 30 minutes before performing the respiratory physiotherapy using airway clearance techniques (ACTs)
Time Frame
basal record
Secondary Outcome Measure Information:
Title
Heart Rate Variability
Description
The heart rate (HR) was recorded with the children in the dorsal decubitus position at 30-degree elevation during 10 minutes after 5 minutes performing the respiratory physiotherapy using airway clearance techniques(ACTs)
Time Frame
5 minutes after ACTs
Title
Heart Rate Variability
Description
The heart rate (HR) was recorded with the children in the dorsal decubitus position at 30-degree elevation after 5 minutes nasotracheal suction (10-minutes record).
Time Frame
5 minutes after nasotracheal suction
Title
Heart Rate Variability
Description
The heart rate (HR) was recorded with the children in the dorsal decubitus position at 30-degree elevation during 40 minutes after nasotracheal suction (30-minute record).
Time Frame
40 minutes after nasotracheal suction

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
11 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: hospitalized children Exclusion Criteria: age above 12 months; presence of cardiovascular disease or chronic respiratory disease; prescription of vasoactive drugs or sedatives; invasive mechanical ventilation; children on contact or respiratory isolation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hugo CD Souza, Ph.D.
Organizational Affiliation
University of São Paulo
Official's Role
Study Director
Facility Information:
Facility Name
University of São Paulo
City
Ribeirão Preto
State/Province
São Paulo
ZIP/Postal Code
14049-900
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
20708981
Citation
Sant'Ana JE, Pereira MG, Dias da Silva VJ, Dambros C, Costa-Neto CM, Souza HC. Effect of the duration of daily aerobic physical training on cardiac autonomic adaptations. Auton Neurosci. 2011 Jan 20;159(1-2):32-7. doi: 10.1016/j.autneu.2010.07.006. Epub 2010 Aug 13.
Results Reference
background
PubMed Identifier
24271093
Citation
Jacinto CP, Gastaldi AC, Aguiar DY, Maida KD, Souza HC. Physical therapy for airway clearance improves cardiac autonomic modulation in children with acute bronchiolitis. Braz J Phys Ther. 2013 Nov-Dec;17(6):533-40. doi: 10.1590/S1413-35552012005000120. Epub 2013 Nov 1.
Results Reference
derived
Links:
URL
http://www.fmrp.usp.br
Description
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Respiratory Physical Therapy on the Cardiac Autonomic Modulation Paediatric Patients

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