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临床试验/NCT01438294
NCT01438294已完成不适用

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

Hospital Sirio-Libanes1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2011年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
36
试验地点
1
主要终点
Exhaled Nitric Oxide (FeNO) Level

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
5 Years 至 11 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: 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).

干预措施: Video game group (Other)

结局指标

主要结局

Exhaled Nitric Oxide (FeNO) Level

时间窗: 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 ®.

次要结局

  • 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)

研究者

发起方
Hospital Sirio-Libanes
申办方类型
Other
责任方
Principal Investigator
主要研究者

Evelim Leal de Freitas Dantas Gomes, PhD

PhD in science Rehabilitation

Hospital Sirio-Libanes

研究点 (1)

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