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Clinical Trials/NCT01438294
NCT01438294CompletedNot Applicable

Effects of Exercise Training on Markers of Lung Inflammation and Clinical Crontrol in Asthma Children

Hospital Sirio-Libanes1 site in 1 country36 target enrollmentStarted: November 1, 2011Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
36
Locations
1
Primary Endpoint
Exhaled Nitric Oxide (FeNO) Level

Study Overview

Brief Summary

The purpose of this study is to assess the effects of a physical training program with active video game in inflammatory markers, quality of life variables , clinical control and physical and functional respiratory assessment of asthmatic children from 5 to 11 years.

Detailed Description

The aim of the present study will be to determine whether an aerobic exercise using an active video game system improves asthma control, lung inflammation and functional capacity in children with moderate or severe asthma.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
5 Years to 11 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Aerobic exercise

Active Comparator

The aerobic training will be done on the treadmill with heart monitors with intensity required to achieve 70% of maximum heart rate reached the maximum test for thirty minutes.

Intervention: Aerobic exercise group (Other)

Video game

Experimental

The training with video game will be done with heart rate monitors with intensity required to achieve 70% of maximum heart rate reached the maximum test for thirty minutes.Will be used Kinect games ( reflex ridge- Adventure).

Intervention: Video game group (Other)

Outcomes

Primary Outcomes

Exhaled Nitric Oxide (FeNO) Level

Time Frame: The FeNO level was performed in week 8

The measurement of exhaled FeNO level 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 Outcomes

  • Treadmil Test (Bruce Protocol)(8 week distance walked on treadmill test)
  • Body Composition(baseline and after 8 weeks)
  • Pulmonary Function(baseline and after 8 weeks)

Investigators

Sponsor
Hospital Sirio-Libanes
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Evelim Leal de Freitas Dantas Gomes, PhD

PhD in science Rehabilitation

Hospital Sirio-Libanes

Study Sites (1)

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