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NIV Application in the Treatment of Asthmatic Children

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ClinicalTrials.gov Identifier: NCT02939625
Recruitment Status : Completed
First Posted : October 20, 2016
Last Update Posted : October 23, 2017
Sponsor:
Information provided by (Responsible Party):
Daysi Tobelem, University of Nove de Julho

Tracking Information
First Submitted Date  ICMJE October 12, 2016
First Posted Date  ICMJE October 20, 2016
Last Update Posted Date October 23, 2017
Study Start Date  ICMJE January 2015
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 17, 2016)
Exhaled nitric oxide (part per billion) [ Time Frame: 5 minutes ]
assess the degree of inflammation of the respiratory system using expired fraction of nitric oxide before and after the different protocols applied
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02939625 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2016)
  • Heart Rate Variability [ Time Frame: 20 minutes ]
  • manovacuometry [ Time Frame: 10 minutes ]
  • Pulmonary function test [ Time Frame: 20 minutes ]
  • bioelectrical impedance [ Time Frame: 10 minutes ]
  • Bronchoconstriction induced by stress [ Time Frame: 30 minutes ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE NIV Application in the Treatment of Asthmatic Children
Official Title  ICMJE Effects of Continuous and Bilevel Positive Airway Pressure During Exercise-induced Bronchoconstriction in Asthmatic Children: Controlled Clinical Trial, Randomized
Brief Summary 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.
Detailed 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Asthma
  • Child
  • Bronchial Spasm
Intervention  ICMJE
  • Device: muscle training
  • Device: Continue Positive Airway Pressure
  • Device: bilevel positive airway pressure
Study Arms  ICMJE
  • Active Comparator: muscle training
    participants will breathing exercises for 20 min, then 40 min training with Threshold IMT therapy will be held in 7 sessions
    Interventions:
    • Device: muscle training
    • Device: Continue Positive Airway Pressure
    • Device: bilevel positive airway pressure
  • Active Comparator: bilevel positive airway pressure
    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
    Interventions:
    • Device: muscle training
    • Device: Continue Positive Airway Pressure
    • Device: bilevel positive airway pressure
  • Active Comparator: Continue Positive Airway Pressure
    participants will breathing exercises for 20 min, then 40 min CPAP (8 cm H2O) therapy will be held in 7 sessions
    Interventions:
    • Device: muscle training
    • Device: Continue Positive Airway Pressure
    • Device: bilevel positive airway pressure
Publications * David MMC, Gomes ELFD, Mello MC, Costa D. Noninvasive ventilation and respiratory physical therapy reduce exercise-induced bronchospasm and pulmonary inflammation in children with asthma: randomized clinical trial. Ther Adv Respir Dis. 2018 Jan-Dec;12:1753466618777723. doi: 10.1177/1753466618777723.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 19, 2017)
68
Original Estimated Enrollment  ICMJE
 (submitted: October 17, 2016)
45
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 11 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02939625
Other Study ID Numbers  ICMJE Rehabilitation in asthma
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Daysi Tobelem, University of Nove de Julho
Study Sponsor  ICMJE University of Nove de Julho
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Nove de Julho
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP