Exercise Training in Asthma Children

Not Applicable

Completed

• Conditions: Asthma
• Interventions: Other: Video game group; Other: Aerobic exercise group

• Registration Number: NCT01438294
• Lead Sponsor: Hospital Sirio-Libanes

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 Timeline

• Study First Submitted: 2011-09-18
• Study First Submitted QC: 2011-09-21
• Study First Posted: 2011-09-22
• Study Start: 2011-11
• Primary Completion: 2013-05
• Study Completion: 2013-11
• Results First Submitted: 2014-07-05
• Status Verified: 2014-10
• Results First Submitted QC: 2014-10-05
• Last Update Submitted: 2014-10-05
• Results First Posted: 2014-10-10
• Last Update Posted: 2014-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Video game	Video game group	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).
Aerobic exercise	Aerobic exercise group	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.

Primary Outcome Measures

Name	Time	Method
Exhaled Nitric Oxide (FeNO) Level	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 Outcome Measures

Name	Time	Method
Treadmil Test (Bruce Protocol)	8 week distance walked on treadmill test	A maximal exercise testing was performed in a treadmill using Bruce protocol that has been used to provide information on exercise capacity, physiopathological characteristics during effort, the efficacy of medications and the potential risk for diseases ( Zijp et al. 2010). The test was interrupted when the child reported maximal fatigue or reached the maximum heart rate around 200bpm (Peyer et al. 2011). During the test, blood pressure and peripheral oxygen saturation were quantified and an electrocardiogram was performed. The Borg scale was used to quantify for the sensation of shortness of breath during effort and at rest (Lamb 1995).; Change from baseline in the distance walked on treadmill test will be consider as outcome measure.
Body Composition	baseline and after 8 weeks	All participants were evaluated individually, always during the afternoon to avoid circadian changes. Height, weight and abdominal circumference were determined. Tetrapolar bioimpedance was measured using the Biodynamics™ model 310 (Biodynamics Corporation Seattle WA, USA) by positioning the child in the supine position and electrodes in the extremity of the right upper and lower limbs (Goran et al.1993).
Pulmonary Function	baseline and after 8 weeks	was performed before and after the inhalation of 400μg of salbutamol (Easy One™, USA), and technical procedures were performed as recommended by ATS/ERS. Predicted normal values were those proposed by Polgar and Promadhat 1971 and a 12% and 200 mL increase in FEV1 from baseline were characterized as a positive response to the bronchodilator) in a climate-controlled room.

Trial Locations

Locations (1)

University Nove de Julho; 🇧🇷 São Paulo, SP, Brazil