Pulmonary Rehabilitation in Asthmatic Patient
2019年8月5日 更新者：Fernanda de Cordoba Lanza
Pulmonary Rehabilitation in Asthmatic Pediatric Patients: Randomized Clinical Trial
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
66
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Sao Paulo、巴西、01504001
- Fernanda C Lanza
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
6年 至 18年 (孩子、成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- between six and 18 years old
- asthma-diagnosed patients
- under medical treatment and disease control
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：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.
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Aerobic training
其他名称：
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有源比较器：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.
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Chest physiotherapy: Flutter and muscle stretching
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Physical capacity as measure by distance walked of shuttle walk test and oxygen consumption (VO2)
大体时间：Physiscal capacity will be measured at the beginning and at the end of the protocol (after 8 weeks)
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Modified shuttle test was conducted
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Physiscal capacity will be measured at the beginning and at the end of the protocol (after 8 weeks)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Muscle strength as measure by electromyography (EMG)
大体时间：Muscles strenght will be measured at the begening and at the end of the protocol (after 8 weeks).
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1 maximal repetition was performed
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Muscles strenght will be measured at the begening and at the end of the protocol (after 8 weeks).
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Muscle endurance as measure by electromyography (EMG)
大体时间：Muscles endurance will be measured at the begening and at the end of the protocol (after 8 weeks).
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Muscles endurance will be measured at the begening and at the end of the protocol (after 8 weeks).
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Quality of life measured by Pediatric questionnaire
大体时间：Quesitionnaire will be measured at the begening and at the end of the protocol (after 8 weeks).
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Quesitionnaire will be measured at the begening and at the end of the protocol (after 8 weeks).
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Inflammatory markers as measure by interleukines
大体时间：Inflamatory markers will be measured at the begening and at the end of the protocol (after 8 weeks).
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Inflamatory markers will be measured at the begening and at the end of the protocol (after 8 weeks).
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 学习椅：Dirceu Solé, PhD、Unifesp, Federal University of Sao Paulo
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Silva EP, Soares BA, Reimberg MM, Ritti-Dias R, Nascimento KS, Anjos FS, Wandalsen GF, Sole D, Dal Corso S, Lanza FC. Heart rate recovery in asthmastic children and adolescents after clinical field test. BMC Pulm Med. 2021 Feb 19;21(1):61. doi: 10.1186/s12890-020-01355-9.
- Reimberg MM, Castro RA, Selman JP, Meneses AS, Politti F, Mallozi MC, Wandalsen GF, Sole D, De Angelis K, Dal Corso S, Lanza FC. Effects of a pulmonary rehabilitation program on physical capacity, peripheral muscle function and inflammatory markers in asthmatic children and adolescents: study protocol for a randomized controlled trial. Trials. 2015 Aug 13;16:346. doi: 10.1186/s13063-015-0876-x.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2015年2月1日
初级完成 (实际的)
2016年7月1日
研究完成 (实际的)
2018年8月1日
研究注册日期
首次提交
2015年2月10日
首先提交符合 QC 标准的
2015年3月3日
首次发布 (估计)
2015年3月9日
研究记录更新
最后更新发布 (实际的)
2019年8月7日
上次提交的符合 QC 标准的更新
2019年8月5日
最后验证
2019年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Intervention Group的临床试验
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University of Illinois at ChicagoShirley Ryan AbilityLab; Oakland University; Access Living主动，不招人
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Centro Hospitalar do PortoUniversity of Trás-os-Montes and Alto Douro; Foundation for Science and Technology, Portugal; Institute...招聘中
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University of Wisconsin, MadisonNational Cancer Institute (NCI); Northwestern University主动，不招人
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Amsterdam UMC, location VUmcRed Cross Hospital Beverwijk完全的
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Case Western Reserve UniversityNational Institutes of Health (NIH); American Heart Association完全的