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Effects of NMES on Energy Expenditure, Glycaemia and Hormonal Responses to Glucose Ingestion

2020年5月11日 更新者:Yung-Chih Chen、National Taiwan Normal University

Effects of Self-selected Maiximal Intensity of Neuromuscular Electrical Stimulation (NMES) on Energy Expenditure, Glycaemia and Hormonal Responses on Healthy Individuals

The purpose of this study is to investigate whether self-selected neuromuscular stimulation (NMES) affects energy expenditure, glycaemia and hormonal responses in healthy men and women

研究概览

详细说明

Participants were asked to perform 3 trials [sitting (SIT), standing (STAND) and sitting with neuromuscular electrical stimulation (NMES) to the lower limbs in randomised counter-balanced study design. Trials were separated by at least 48 h and were completed within 14 days. In all trials, participants were required to remain relaxed and motionless. SIT: participants sat in a chair with back, arms and legs supported. STAND: participants were asked to stand with arms supported and feet spaced approximately 15 cm apart. If needed, adjustment of standing posture was allowed during the standing trial to prevent orthostatic hypotension. NMES: prior to the NMES trial, participants underwent preliminary testing to ensure that stimulation was comfortable. Before the NMES, a small area of the body hair was shaved and skin was cleaned with an alcohol wipe and electrodes were stuck to the surface of the skin. Small electrodes placed (5*5 cm) on the lower limb of both legs (gastrocnemius, rectus femoris, vastus medialis). The two devices (EM 80, Beurer UK Ltd, Golborne, UK) were set up with the frequency of 20 Hz along with stimulation period of 1 second on and 1 second off throughout a 2 h oral glucose tolerance test (OGTT). The instruction for NMES intensity was that the maximal intensity participants were be able to withstand for 2 hours whilst imagining sitting at home watching TV without feeling discomfort. Prior to the OGTT, 5 min was given to identify the suitable intensity of stimulation and within the first 10 min of the OGTT participants were allowed to adjust the intensity once, after which, the intensity remained the same for the rest of OGTT. Participants were asked to sit in a chair with back, arms and legs supported during the stimulation. During trials, participants could watch TV, or read, but typing on a laptop or computer were avoided.

研究类型

介入性

注册 (实际的)

9

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

      • Taipei、台湾
        • National Taiwan Normal University

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

18年 至 65年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Healthy men and women
  • Aged between 18 to 65 years
  • Weight stable for more than 3 months (no change in weight +/- 3%)
  • Non-smoker

Exclusion Criteria:

  • Personal history of/existing diabetes, cardiovascular disease, metabolic disease or dyslipidaemia
  • Taking medications that may influence lipid or carbohydrate metabolism or immune system function

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:基础科学
  • 分配:随机化
  • 介入模型:交叉作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:SIT
Sitting
Participants sat in a chair with back, arms and legs supported.
实验性的:STAND
Standing
Participants were asked to stand with arms supported and feet spaced approximately 15 cm apart. If needed, adjustment of standing posture was allowed during standing trial to prevent orthostatic hypotension.
实验性的:NMES
Self-selected maximal intensity of neuromuscular electrical stimulation
Small electrodes placed (5*5 cm) on the lower limb of both legs. The instruction for NMES intensity was that the maximal intensity participants were be able to withstand for 2 hours whilst imagining sitting at home watching TV without feeling discomfort.

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
Changes in total energy expenditure during OGTT test.
大体时间:120 minutes
Changes in total energy expenditure during OGTT test.
120 minutes

次要结果测量

结果测量
措施说明
大体时间
Changes in blood glycaemic responses during OGTT test.
大体时间:120 minutes
Changes in blood glycaemic responses during OGTT test.
120 minutes
Changes in blood insulinaemic responses during OGTT test.
大体时间:120 minutes
Changes in blood insulinaemic responses during OGTT test.
120 minutes
Changes in blood pressure during OGTT test.
大体时间:120 minutes
Changes in blood pressure during OGTT test.
120 minutes
Changes in heart rate during OGTT test.
大体时间:120 minutes
Changes in heart rate during OGTT test.
120 minutes
Changes in gut hormones (GLP-1, GIP & PYY etc.) responses during OGTT test.
大体时间:120 minutes
Changes in gut hormones (GLP-1, GIP & PYY etc.) responses during OGTT test.
120 minutes
Changes in total carbohydrate during OGTT test.
大体时间:120 minutes
Changes in total carbohydrate during OGTT test.
120 minutes
Changes in total lipid oxidation during OGTT test.
大体时间:120 minutes
Changes in total lipid oxidation during OGTT test.
120 minutes

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。

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。

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)

2018年11月27日

初级完成 (实际的)

2019年1月9日

研究完成 (实际的)

2019年1月20日

研究注册日期

首次提交

2020年3月27日

首先提交符合 QC 标准的

2020年5月11日

首次发布 (实际的)

2020年5月15日

研究记录更新

最后更新发布 (实际的)

2020年5月15日

上次提交的符合 QC 标准的更新

2020年5月11日

最后验证

2020年5月1日

更多信息

与本研究相关的术语

其他研究编号

  • EP 17/18 230

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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.

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