Exercise With or Without Electrical Stimulation in Cystic Fibrosis (Part I): Effects on Physical Fitness (ECOMIRIN)
2020年7月23日 更新者：Margarita Perez、Universidad Europea de Madrid
Effects of Exercise With or Without Electrical Stimulation in Physical Fitness in Cystic Fibrosis: an Integrated Vision (ECOMIRIN Study)
This study aims to assess the effects of programmed exercise with or without electrical stimulation in the cardiorespiratory fitness, strength, functional capacity and agility in a group of young patients with Cystic Fibrosis: A randomized controlled trial comparing two interventions with a control group.
研究概览
研究类型
介入性
注册 (实际的)
27
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
-
-
-
Villaviciosa De Odón、西班牙、28670
- Escuela de Doctorado e Investigacion, Universidad Europea
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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
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Diagnosis of CF
- Age: 6-18 years old
- Signature of informed consent of legal guardian and patient.
Exclusion Criteria:
- Being a smoker
- Having had an exacerbation in the last 3 months
- Having undergone gastric surgery
- Having enteral nutrition at present
- The patients will come from the HIUNJ of Madrid.
- Currently taking CFTR modulators
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 |
|---|---|
|
无干预：Control
This group will continue with regular visits to the specialist.
This visits include recommendations to improve lifestyle.
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实验性的：Exercise-No NMES
This group will continue with regular visits to the specialist. This visits include recommendations to improve lifestyle. The exercise protocol includes a concurrent exercise intervention (strength training and aerobic training), 3 days a week, 60 minutes sessions. |
Exercise-No NMES
|
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实验性的：Exercise-NMES
This group will continue with regular visits to the specialist. This visits include recommendations to improve lifestyle. The exercise protocol includes a concurrent exercise intervention (strength training and aerobic training), 3 days a week, 60 minutes sessions. Additionally, this group will receive neuromuscular electrical stimulation (NMES) concomitant to the strength training. |
Exercise-NMES
|
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 |
|---|---|---|
|
Change in Strength
大体时间：Two assessment points throughout the study: baseline and 8 weeks after the intervention
|
Changes in strength will be measured using a five repetition maximum test (5RM)
|
Two assessment points throughout the study: baseline and 8 weeks after the intervention
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Cardiorespiratory Fitness
大体时间：Two assessment points throughout the study:baseline and 8 weeks after the intervention
|
Changes in cardiorespiratory fitness will be measured using a cardiopulmonary exercise test (CPET)
|
Two assessment points throughout the study:baseline and 8 weeks after the intervention
|
|
Changes in Pulmonary Function
大体时间：Two assessment points throughout the study:baseline and 8 weeks after the intervention
|
Changes in pulmonary function will be measured using Spirometry
|
Two assessment points throughout the study:baseline and 8 weeks after the intervention
|
|
Changes in physical activity levels
大体时间：Two assessment points throughout the study:baseline and 8 weeks after the intervention
|
Changes in physical activity levels will be measured using Physical Activity Questionnaire for Children and Adolescents (PAC-C or PAC-A)
|
Two assessment points throughout the study:baseline and 8 weeks after the intervention
|
|
Change in quality of life
大体时间：Two assessment points throughout the study:baseline and 8 weeks after the intervention
|
Changes in quality of life will be measures with the Cystic Fibrosis-Questionnaire-Revised (CFQ-R)
|
Two assessment points throughout the study:baseline and 8 weeks after the intervention
|
|
Food consumption frequency
大体时间：One assessment point at baseline:baseline and 8 weeks after the intervention
|
The food consumption frequency will be measured using food frequency questionnaire (FFQ)
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One assessment point at baseline:baseline and 8 weeks after the intervention
|
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。
调查人员
- 首席研究员：Margarita Perez Ruiz, MD、Universidad Europea de Madrid
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)
2019年1月15日
初级完成 (实际的)
2020年3月9日
研究完成 (实际的)
2020年3月9日
研究注册日期
首次提交
2019年10月30日
首先提交符合 QC 标准的
2019年11月3日
首次发布 (实际的)
2019年11月6日
研究记录更新
最后更新发布 (实际的)
2020年7月24日
上次提交的符合 QC 标准的更新
2020年7月23日
最后验证
2020年7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.