Effects of Functional Electrical Stimulation on Metaboreflex Activation in Healthy Individuals
2015年5月18日 更新者：Beatriz D'Agord Schaan、Hospital de Clinicas de Porto Alegre
Effects of Functional Electrical Stimulation Compared to Isometric Exercise on Metaboreflex Activation in Healthy Individuals: Randomized Crossover Clinical Trial
Cardiovascular exercise adjustments are required during in order to redistribute blood flow from non-exercising vascular areas to active muscles.
This hemodynamic adjustments, which are partially mediated by mechanosensitive and metabosensitive reflexes, ultimately increase oxygen and nutrient delivery to exercising muscle tissues (Mitchell, 1990).
Static handgrip exercise has been shown to induce alterations in the arterial baroreflex function (Kim, 2005) and activation of muscle metaboreflex that increases arterial blood pressure and peripheral vasoconstriction, respectively.
Functional electrical stimulation (FES) treatment used in physical therapy in patients who are unable to tolerate conventional exercise showed to be a good alternative for muscle strengthening (Sbruzzi, 2010) and to improve metabolic abnormalities (Karavidas, 2006).
However, the effect of FES on metaboreflex activation in healthy individuals has never been investigated.
Therefore, this study aims to evaluate the metaboreflex activation induced by FES in upper and low limbs in healthy individuals, and also to compare their results with the effects caused by isometric exercise.
研究概览
详细说明
All participants will be invited to attend four separate days for completion of the study protocols.
On the first day, the metaboreflex activation in upper limb will be randomly assigned to isometric exercise or FES intervention.
On the second day, at least two days apart, random isometric exercise or FES intervention will be performed in the upper limb.
On the third day, at least one week apart, all participants will be assigned to perform metaboreflex in a lower limb induced by isometric exercise or FES intervention.
On the fourth day, at least two days apart, random isometric exercise or FES intervention will be performed in a lower limb.
To evaluate the isometric exercise and FES intervention the post-exercise ischemia will be randomly performed to evaluate the accumulation of metabolites in response to activated limb (PECO +) and evaluation control without ischemia (PECO-).
The experiments between PECO+ and PECO- will be separated by a 30 min interval.
During isometric exercise and FES protocols the blood flow and peripheral vascular resistance will be assessed by venous occlusion plethysmography.
Fatigue will be determined every minute by the 10-point Borg scale to assess rate of perceived exertion and by blood lactate.
Blood lactate will be evaluated through capillary action at pre, immediately post exercise and at 5 minutes during the recovery period.
Hemodynamic variables such as BP and HR will be recorded every minute during the protocols.
研究类型
介入性
注册 (预期的)
20
阶段
- 第一阶段早期
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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RS
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Porto Alegre、RS、巴西、90035-003
- 招聘中
- Hospital de Clínicas de Porto Alegre
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首席研究员：
- Beatriz Schaan, PhD
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接触：
- Aline Macedo, Graduate
- 电话号码：+55 51 97016966
- 邮箱：alinechagastelles@gmail.com
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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
35年 至 70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 individuals
- Both genders
- Aged 35-70 years
- Sedentary
- Not using continuous medications
Exclusion Criteria:
- Cardiovascular disease
- Neurological disease
- Malignant disease
- Peripheral vascular disorders (varicose veins or deep vein thrombosis)
- Peripheral sensitivity alterations
- Contraindication to performing physical exercise
- Refusal to sign the consent form
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：交叉作业
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Functional electric stimulation
Other: The FES will be placed at the flexor muscles of the forearm and knee extensors, for evaluation of upper and lower limbs, respectively.
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The FES will be placed at the flexor muscles of the forearm and knee extensors, for evaluation of upper and lower limbs, respectively.
The stimulation frequency will be 20 Hz.
The pulse width used will be 0.5 milliseconds and the contraction time will be 60 seconds (TON: 60s) with a 1-second rest interval (TOFF: 1s).
The total time of application will be determined for the muscle fatigue that will be evaluated by 10-point Borg scale and by the measurement of lactate accumulation that must not exceed 30 minutes.
The intensity will be adjusted individually, taking into account the patient's ability to promote the full flexion of the wrist / knee extension and comfort during contractions.
Along with the application of FES a 1 Kg overload will be applied to intensify the fatigue time.
其他名称：
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安慰剂比较：Isometric exercise
For the upper limbs the isometric contraction exercise with handgrip will be performed for 5 minutes with 30% of loading, previously measured by maximum voluntary contraction test.
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For the upper limbs the isometric contraction exercise with handgrip will be performed for 5 minutes with 30% of loading, previously measured by maximum voluntary contraction test.
For the lower limbs the knee extension exercise will be conducted in a training station.
The SBP, DBP, MBP and HR will be recorded through the protocols.
Fatigue will be determined every minute by the 10-point Borg scale and by measurement of lactate accumulation before, immediately after the protocol, and 5 minutes during the recovery period.
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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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Forearm and calf blood flow change
大体时间：5 minutes of exercise ( when PECO-) or to fatigue (when PECO +)
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When performed the protocol with FES measurements will be taken for 3 minutes of rest (in both PECO+ and PECO-), 5 minutes of exercise (when PECO-) or to fatigue (when PECO +), during the 3 minutes of occlusion (when PECO +) and 3 minutes final recovery (in both PECO+ and PECO-).
When performed the protocol with isometric exercise measurements will be at 3 minutes basal (in both PECO+ and PECO-), 3 minutes of exercise (in both PECO+ and PECO-), 3 minutes of occlusion when PECO + and 3 minutes of ultimate recovery (in both PECO+ and PECO-).
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5 minutes of exercise ( when PECO-) or to fatigue (when PECO +)
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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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Maximum muscle strength
大体时间：The maximum peak strength will be measured 3 times with 1 minute interval between each measurement before a session of isometric exercise
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Before starting the evaluations of blood flow, the maximum peak strength is measured three times with 1 minute interval between each measurement, after is calculated 30% of the maximum value and the determined load exercise.
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The maximum peak strength will be measured 3 times with 1 minute interval between each measurement before a session of isometric exercise
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Peripheral vascular resistance
大体时间：It is calculated using data obtained from blood flow and mean arterial pressure in the protocols at 3 minutes in both PECO+ and PECO-
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Ratio between the mean arterial pressure (MBP) and muscle blood flow.
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It is calculated using data obtained from blood flow and mean arterial pressure in the protocols at 3 minutes in both PECO+ and PECO-
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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。
调查人员
- 首席研究员：Beatriz Dr Schaan, PhD、Hospital de Clínicas de Porto Alegre
- 学习椅：Aline Macedo, Graduate、Federal University of Rio Grande do Sul
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
- Sbruzzi G, Ribeiro RA, Schaan BD, Signori LU, Silva AM, Irigoyen MC, Plentz RD. Functional electrical stimulation in the treatment of patients with chronic heart failure: a meta-analysis of randomized controlled trials. Eur J Cardiovasc Prev Rehabil. 2010 Jun;17(3):254-60. doi: 10.1097/HJR.0b013e328339b5a2.
- Mitchell JH. J.B. Wolffe memorial lecture. Neural control of the circulation during exercise. Med Sci Sports Exerc. 1990 Apr;22(2):141-54. No abstract available.
- Rowell LB, O'Leary DS. Reflex control of the circulation during exercise: chemoreflexes and mechanoreflexes. J Appl Physiol (1985). 1990 Aug;69(2):407-18. doi: 10.1152/jappl.1990.69.2.407.
- Kim JK, Sala-Mercado JA, Rodriguez J, Scislo TJ, O'Leary DS. Arterial baroreflex alters strength and mechanisms of muscle metaboreflex during dynamic exercise. Am J Physiol Heart Circ Physiol. 2005 Mar;288(3):H1374-80. doi: 10.1152/ajpheart.01040.2004. Epub 2004 Nov 11.
- Karavidas AI, Raisakis KG, Parissis JT, Tsekoura DK, Adamopoulos S, Korres DA, Farmakis D, Zacharoulis A, Fotiadis I, Matsakas E, Zacharoulis A. Functional electrical stimulation improves endothelial function and reduces peripheral immune responses in patients with chronic heart failure. Eur J Cardiovasc Prev Rehabil. 2006 Aug;13(4):592-7. doi: 10.1097/01.hjr.0000219111.02544.ff.
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
2015年3月1日
初级完成 (预期的)
2015年12月1日
研究完成 (预期的)
2016年3月1日
研究注册日期
首次提交
2015年5月11日
首先提交符合 QC 标准的
2015年5月14日
首次发布 (估计)
2015年5月19日
研究记录更新
最后更新发布 (估计)
2015年5月20日
上次提交的符合 QC 标准的更新
2015年5月18日
最后验证
2015年5月1日
更多信息
与本研究相关的术语
其他研究编号
- 14-0359
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.
Functional electric stimulation的临床试验
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Consorci d'Atenció Primària de Salut de l'EixampleMedtronic完全的
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Mayo ClinicNational Institute of Mental Health (NIMH)招聘中
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Boston Children's HospitalGeneral Electric完全的