NCT01354561

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

May 9, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 17, 2011

Completed
Last Updated

May 17, 2011

Status Verified

May 1, 2011

Enrollment Period

2.2 years

First QC Date

May 9, 2011

Last Update Submit

May 13, 2011

Conditions

Viral Bronchiolitis

Keywords

respiratory physiotherapycardiac autonomic modulationpaediatric patients

Outcome Measures

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)

    basal record

Secondary Outcomes (3)

  • Heart Rate Variability

    5 minutes after ACTs

  • Heart Rate Variability

    5 minutes after nasotracheal suction

  • Heart Rate Variability

    40 minutes after nasotracheal suction

Study Arms (2)

control group

SHAM COMPARATOR

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

respiratory disease group

ACTIVE COMPARATOR

Respiratory disease group consisting of hospitalized children with acute viral bronchiolitis

Procedure: Respiratory physical therapy

Interventions

Respiratory physical therapyPROCEDURE

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
control grouprespiratory disease group

Eligibility Criteria

Age2 Months - 11 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • hospitalized children

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of São Paulo

Ribeirão Preto, São Paulo, 14049-900, Brazil

Location

Related Publications (2)

  • 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.

    PMID: 20708981BACKGROUND

  • 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.

    PMID: 24271093DERIVED

Related Links

MeSH Terms

Conditions

Bronchiolitis, Viral

Condition Hierarchy (Ancestors)

BronchiolitisBronchitisRespiratory Tract InfectionsInfectionsVirus DiseasesBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Study Officials

  • Hugo CD Souza, Ph.D.

    University of Sao Paulo

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 9, 2011

First Posted

May 17, 2011

Study Start

February 1, 2007

Primary Completion

May 1, 2009

Study Completion

May 1, 2010

Last Updated

May 17, 2011

Record last verified: 2011-05

Locations

BR(1)