Pulmonary Rehabilitation in Asthmatic Pediatric Patients: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Physical capacity as measure by distance walked of shuttle walk test and oxygen consumption (VO2)
研究概览
简要总结
Asthma is one of the main chronic diseases in childhood and it is characterized by the inflammation of airways. Individuals with chronic lung disease are more susceptible to present reduction in exercise tolerance due to pulmonary limitations. The pulmonary rehabilitation may improve the physical capacity in asthmatic patients, as observed in other chronic lung diseases.
详细描述
The asthmatic patient's clinical changes may impair their functional capacity and exercise tolerance. Thus, the treatment of these individuals should be extended to pulmonary rehabilitation. Randomized clinical trials have shown interesting results, whether in cardiopulmonary conditions, quality of life or in the number of crises, after applying pulmonary rehabilitation program in asthmatic children and adolescents. In a systematic review on physical training with asthmatic children and adolescents the authors concluded that physical activity should be recommended to this population, although some issues have not yet been clarified due to limitations in the clinical trial. The control of the disease has not been evaluated by specific questionnaires in any study. The assessment of inflammatory markers was rarely addressed and the same occurred in the quality of life after physical training. In addition, it is possible to question the intensity and frequency of training, factors that can significantly contribute to the intervention results. All these information let us know that is necessary a randomized control trial to answer questions about physical characteristics, quality of life, inflammatory markers, and muscles strength.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •between six and 18 years old
- •asthma-diagnosed patients
- •under medical treatment and disease control
排除标准
- •fail to carry out the protocol evaluations
- •interrupt the medical care and/or drug-based treatment
- •acute lung infection or other chronic lung diseases
- •other comorbidities (neuropathies, heart disease)
- •missing in more than 20% the rehabilitation protocol
研究组 & 干预措施
Intervention Group
The intervention group will have supervised rehabilitation program held twice a week, each session will have 60 minutes duration, with minimum interval of 24 hours, for a period of 8 weeks. Each session will consist of three parts: aerobic training, strength training and respiratory physiotherapy. The aerobic training will be held for 35 minutes (10 min of warm up, 20 min on target load and 5 min of slowdown) with initial intensity of 60% of the maximum load obtained in the maximal cardiopulmonary exercise testing or in incremental shuttle walk test (ISWT). The intensity will be gradually increased up to 80%, so that fatigue or dyspnea values are kept between 4 and 6, according to the modified Borg scale.
干预措施: Intervention Group (Other)
Control Group
The control group will be subjected to supervised respiratory physiotherapy and stretching exercises twice a week, each session with duration of 60 minutes, with minimum interval of 24 hours, for a period of 8 weeks. The oral high-frequency oscillation device (Flutter®) will be used for 10 minutes, 5 minutes in each lateral decubitus, followed by the stretching of upper and lower limbs for 40 minutes. All exercises will be active, performed in sitting and lying positions without increasing the heart rate. The remaining 10 minutes will be used to discuss doubts about the disease and the use of the booklet.
干预措施: Control Group (Other)
结局指标
主要结局
Physical capacity as measure by distance walked of shuttle walk test and oxygen consumption (VO2)
时间窗: Physiscal capacity will be measured at the beginning and at the end of the protocol (after 8 weeks)
Modified shuttle test was conducted
次要结局
- Muscle endurance as measure by electromyography (EMG)(Muscles endurance will be measured at the begening and at the end of the protocol (after 8 weeks).)
- Quality of life measured by Pediatric questionnaire(Quesitionnaire will be measured at the begening and at the end of the protocol (after 8 weeks).)
- Muscle strength as measure by electromyography (EMG)(Muscles strenght will be measured at the begening and at the end of the protocol (after 8 weeks).)
- Inflammatory markers as measure by interleukines(Inflamatory markers will be measured at the begening and at the end of the protocol (after 8 weeks).)
研究者
Fernanda de Cordoba Lanza
PhD, Professor
University of Nove de Julho