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CompletedNCT01354561Updated May 17, 2011

Respiratory Physical Therapy on the Cardiac Autonomic Modulation Paediatric Patients

An interventional study of Respiratory physical therapy in Viral Bronchiolitis, sponsored by University of Sao Paulo. Completed at 1 site in Brazil. Open to participants aged 2 Months to 11 Months. Per ClinicalTrials.gov, last updated 2011-05-17.

Sponsored by University of Sao Paulo · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Non-randomized
Ages
2 Months to 11 Months
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Viral Bronchiolitis

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Keywords

  • respiratory physiotherapy
  • cardiac autonomic modulation
  • paediatric patients
03

In context

Bronchiolitis, Viral

30 studies on the registry are indexed under Bronchiolitis, Viral; 2 are open to participants now.

This study's enrollment of 24 is below the median of 85 across 25 interventional studies indexed under Bronchiolitis, Viral.

Browse Bronchiolitis, Viral studies →

Lead sponsor

University of Sao Paulo is the lead sponsor of 1,035 studies on the registry; 95 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Months to 11 Months
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • hospitalized children

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Sham comparator
    control group

    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.

    Procedure: Respiratory physical therapy

  • Active comparator
    respiratory disease group

    Respiratory disease group consisting of hospitalized children with acute viral bronchiolitis

    Procedure: Respiratory physical therapy

Interventions

  • ProcedureRespiratory physical therapy

    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.

    Also known as: chest therapy

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What researchers measure

Primary outcomes

  1. 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)

    Time frame: basal record

Secondary outcomes

  1. 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)

    Time frame: 5 minutes after ACTs

  2. 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).

    Time frame: 5 minutes after nasotracheal suction

  3. 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).

    Time frame: 40 minutes after nasotracheal suction

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Study locations

1 site
  • University of São Paulo
    Ribeirão Preto, São Paulo 14049-900, Brazil
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References and documents

Publications

  • 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. PubMed 20708981 ↗
  • 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. PubMed 24271093 ↗

Related links

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 17, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01354561
First posted
May 17, 2011
Start date
Feb 2007
Primary completion
May 2009
Completion
May 2010
Last update
May 17, 2011

Study contacts

Hugo CD Souza, Ph.D.
study director · University of Sao Paulo

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2011. You cannot join it, but the record below documents what was studied.

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