Text Size

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
  Purpose

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.


Condition Intervention
Asthma
 Other: Video game group
Other: Aerobic exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effects of Exercise Training on Markers of Lung Inflammation in Asthma Children

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital Sirio-Libanes:

Primary Outcome Measures:
  • 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 ®.



Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 63
Study Start Date: November 2011
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

 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: 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).
 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).

  Eligibility

Ages Eligible for Study:   5 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01438294

Locations
Brazil
University Nove de Julho
São Paulo, SP, Brazil, 05001-972
Sponsors and Collaborators
Hospital Sirio-Libanes
University of Nove de Julho
Investigators
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
  More Information

No publications provided

Responsible Party: Evelim Leal de Freitas Dantas Gomes, Master in science Rehabilitation, Hospital Sirio-Libanes
ClinicalTrials.gov Identifier: NCT01438294     History of Changes
Other Study ID Numbers: ASMAPED
Study First Received: September 18, 2011
Last Updated: August 28, 2012
Health Authority: Brazil: National Committee of Ethics in Research
Brazil: National Health Surveillance Agency

Keywords provided by Hospital Sirio-Libanes:
Asthma
childhood
exercise

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 21, 2013