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NIV Application in the Treatment of Asthmatic Children

U

University of Nove de Julho

Status

Completed

Conditions

Asthma
Child
Bronchial Spasm

Treatments

Device: bilevel positive airway pressure
Device: muscle training
Device: Continue Positive Airway Pressure

Study type

Interventional

Funder types

Other

Identifiers

NCT02939625
Rehabilitation in asthma

Details and patient eligibility

About

Asthma is characterized by recurrent episodes of bronchospasm, bronchial hyperresponsiveness and chronic airway inflammation and pharmacological treatment for this condition is done with bronchodilators and anti-inflammatory.

Full description

Pharmacologic therapy has clinical efficacy in the control, but the patient often does not adhere adequately.

There is need for further research into non-pharmacological therapies for clinical asthma control and in turn the use of CPAP and bilevel pressure in the airways has shown beneficial effects on autonomic modulation and bronchial responsiveness leading to the hypothesis that these therapies also have effects on the BIE.The aim of this study is to evaluate the effect of these non-pharmacological therapies in several variables and especially the BIE.

Enrollment

68 patients

Sex

All

Ages

5 to 11 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age between 5:11 years;
  • Both sexes;
  • Do not be included in any regular physical activity program;
  • Having a diagnosis of asthma, according to the Global Initiative for Asthma (GINA);
  • Not having received Theophylline or aminophylline and oral corticosteroids in the last 30 days;
  • not have presented respiratory infection in the last two months;
  • Signature of IC

Exclusion criteria

  • Have done inhaled bronchodilator in less than 12 hours before the assessment;
  • Inability to understand or perform any of the tests, due to physical and mental limitations;
  • Intolerance proposed activities;
  • Have heart disease inflammatory, congenital or ischemic origin;
  • Being in the presence of any infectious process with fever.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

68 participants in 3 patient groups

muscle training
Active Comparator group
Description:
participants will breathing exercises for 20 min, then 40 min training with Threshold IMT therapy will be held in 7 sessions
Treatment:
Device: Continue Positive Airway Pressure
Device: muscle training
Device: bilevel positive airway pressure
bilevel positive airway pressure
Active Comparator group
Description:
participants will breathing exercises for 20 min, then 40 min bilevel (IPAP and EPAP 12 = 8 cm H2O), the therapy will be held in 7 sessions
Treatment:
Device: Continue Positive Airway Pressure
Device: muscle training
Device: bilevel positive airway pressure
Continue Positive Airway Pressure
Active Comparator group
Description:
participants will breathing exercises for 20 min, then 40 min CPAP (8 cm H2O) therapy will be held in 7 sessions
Treatment:
Device: Continue Positive Airway Pressure
Device: muscle training
Device: bilevel positive airway pressure

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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