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Exercise Training in Asthma Children

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
University of Nove de Julho
Information provided by (Responsible Party):
Evelim Leal de Freitas Dantas Gomes, Hospital Sirio-Libanes
ClinicalTrials.gov Identifier:
NCT01438294
First received: September 18, 2011
Last updated: August 28, 2012
Last verified: August 2012
History of Changes

September 18, 2011
August 28, 2012
November 2011
May 2013   (final data collection date for primary outcome measure)
Exhaled nitric oxide (FeNO) [ Time Frame: change from baseline exhaled nitric oxide in 6 weeks ] [ Designated as safety issue: Yes ]

The measurement of FeNO is performed by several commercially available devices, however the equipment NIOX ® (Aerocrine, Sweden) analyzer is the only FDA-approved and Anvisa (Food and Drug Administration) for clinical monitoring of asthma.

The measure will be performed before and after the training program of exercise, or pulmonary rehabilitation, by means of portable equipment NIOX MINO ®.
Same as current
Complete list of historical versions of study NCT01438294 on ClinicalTrials.gov Archive Site
Shuttle walk test(SWT) [ Time Frame: Change from baseline in the distance walked in 6 weeks ] [ Designated as safety issue: Yes ]
SWT is a walking test, with progressive loading, which has 15 levels. In this test the patient must walk quickly, increasing speeds on a course of 10 meters, bounded at each end by a cone, which must be overcome by the patient. It is part of a test audio signal that represents the change in level, as well as the increase in speed during the test. The test should be discontinued when the child does not reach the end of 10 meters to the tone.
Same as current
Not Provided
Not Provided
 
Exercise Training in Asthma Children
Effects of Exercise Training on Markers of Lung Inflammation in Asthma Children

The purpose of this study is to assess the effects of a physical training program playful in inflammatory markers, quality of life variables and physical and functional respiratory assessment of asthmatic children from 5 to 11 years.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Asthma
  • Other: Video game group
    The training with video game will be done with heart rate monitors with intensity required to achieve 85% of maximum heart rate reached the maximum test for thirty minutes.Will be used Kinect games ( adventure and sports).
  • Other: Aerobic exercise

    Maximum inspiratory pressure (MIP) will be calculated at the beginning of each session and will be used the same 40% for training in 5 sets of 20 repetitions for RMT.

    The training will be done on the treadmill with heart monitors with intensity required to achieve 85% of maximum heart rate reached the maximum test for thirty minutes.
  • Active Comparator: Aerobic exercise

    Maximum inspiratory pressure(MIP) will be calculated at the beginning of each session and will be used the same 40% for training in 5 sets of 20 repetitions for respiratory muscle training(RMT).

    The aerobic training will be done on the treadmill with heart monitors with intensity required to achieve 85% of maximum heart rate reached the maximum test for thirty minutes.

    Intervention: Other: Aerobic exercise
  • Active Comparator: Video game
    The training with video game will be done with heart rate monitors with intensity required to achieve 85% of maximum heart rate reached the maximum test for thirty minutes.Will be used Kinect games ( adventure and sports).
    Intervention: Other: Video game group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
63
November 2013
May 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Ages 5 to 11 years;
  • Having a diagnosis of asthma, according to the criteria of the National Heart, Lung, and Blood Institute, and
  • Not be included in any program of regular physical activity.

Exclusion Criteria:

  • Having received aminophylline and theophylline or oral corticosteroids in the last 30 days;
  • Respiratory infection have shown over the past two months;
  • Have done with inhaled bronchodilator in less than 12 hours before the assessment;
  • Inability to perform any of the tests;
  • Have heart disease of inflammatory origin, congenital or ischemic;
  • Being in the presence of any infectious process with fever and
  • Do not agree to the terms of consent
Both
5 Years to 11 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01438294
ASMAPED
No
Evelim Leal de Freitas Dantas Gomes, Hospital Sirio-Libanes
Hospital Sirio-Libanes
University of Nove de Julho
Principal Investigator: Evelim Leal F DantasGomes, Master University of Nove de Julho
Study Chair: Dirceu Costa, PhD University of Nove de Julho
Study Director: Luciana Maria M Sampaio, PhD University of Nove de Julho
Hospital Sirio-Libanes
August 2012

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