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临床试验/NCT03905772
NCT03905772暂停不适用

Neuromuscular Adaptations After Training With Neuromuscular Electrical Stimulation Applied Over Nerve Trunk Compared With a Muscle Belly of Triceps Surae: Randomized Controlled Trial

University of Brasilia2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年4月15日最近更新:
适应症

试验速览

阶段
不适用
状态
暂停
发起方
入组人数
60
试验地点
2
主要终点
Change from Baseline Peripheral contribution (M wave) after 15 minutes of acute session of electrical stimulation

研究概览

简要总结

This study aims to evaluate on an acute session of the central and peripheral contributions of electrical stimulation on the muscle belly of the triceps surae, electrical stimulation of the tibial nerve and voluntary exercise of the triceps surae muscle, and identify responders individuals and non-responders to stimulation of the tibial nerve. Another objective of the study is to compare the effects of conventional electrical stimulation applied to the sciatic triceps muscle, tibial nerve stimulation and voluntary exercise after eight weeks of training in healthy individuals.

详细描述

A controlled randomized controlled trial will be carried out by university students, divided equally into four groups: control group (GC), long responding pulse group (PLR), non-responder long pulse group (PLNR) and pulsed current group (CP) after the acute fase of the protocol. Muscular architecture (muscle thickness, pennation angle and fascicle length) of the muscles composing the sural triceps, H-reflex and M-wave tests (central and peripheral contribution), electromyographic signals of the medial and lateral gastrocnemius muscles and sole, voluntary and evoked joint torque of the muscles composing the sural triceps and level of sensorial discomfort. The independent intervention with the neuromuscular electrical stimulation and the isometric exercises performed by the control group will be considered as an independent variable. All groups will have the dependent variables evaluated 6 times, before, during and after the intervention, which will consist of 24 sessions (8 weeks). The training with neuromuscular electrical stimulation (NMES) will be performed 3 times a week and will never be applied for two consecutive days, as well as the voluntary exercises performed by the control group.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Classified as physically active according to the INTERNATIONAL QUESTIONNAIRE OF PHYSICAL ACTIVITY,
  • To practice only recreational physical activity,
  • Achieve minimum torque of 30% of the (maximal voluntary isometric contraction during conventional NMES
  • Be at least 3 months without practicing strength training.

排除标准

  • Present some type of skeletal muscle dysfunction that may interfere with the tests,
  • Present intolerance to NMES in the muscular or tibial nerve, Make use of analgesics, antidepressants, tranquillizers or other agents of central action
  • To present cardiovascular or peripheral vascular problems, chronic diseases, neurological or muscular affections that will undermine the complete execution of the study design by the volunteer.

结局指标

主要结局

Change from Baseline Peripheral contribution (M wave) after 15 minutes of acute session of electrical stimulation

时间窗: Baseline and after 15 minutes of electrical stimulation in the acute session

Peripheral contribution will be measured before and after acute session 15 minutes (36 contractions) of electrical stimulation in the acute session.

Change from Baseline Voluntary torque after 8 weeks of training with electrical stimulation

时间窗: Baseline and after 8 weeks of training with electrical stimulation

Voluntary torque will be evaluated by an isokinetic dynamometer before and after an 8-week training period with electrical stimulation.

Change from Baseline Central contribution (H reflex) after 8 weeks of training with electrical stimulation.

时间窗: Baseline and after 8 weeks of training with electrical stimulation.

Central contribution will be measured before and after 8 weeks of training with electrical stimulation.

Change from Baseline Electromyographic signals after 8 weeks of training with electrical stimulation

时间窗: Baseline and after 8 weeks of training with electrical stimulation

Electromyographic signals will be evaluated by an electromyography before and after an 8-week training period with electrical stimulation.

Change from Baseline Central contribution (H reflex) after 15 minutes of acute session of electrical stimulation.

时间窗: Baseline and after 15 minutes of electrical stimulation in the acute session.

Central contribution will be measured before and after 15 minutes (36 contractions) of electrical stimulation in the acute session.

Change from Baseline Peripheral contribution (M wave) after 8 weeks of traning with electrical atimulation

时间窗: Baseline and after 8 weeks of training with electrical stimulation

Peripheral contribution will be measured before and after 8 weeks of training with electrical stimulation.

次要结局

  • Change from Baseline Discomfort sensory after 8 weeks of training with electrical stimulation(Baseline and after 8 weeks of training with electrical stimulation)
  • Change from Baseline Evoked torque after 8 weeks of training with electrical stimulation(Baseline and after 8 weeks of training with electrical stimulation)

研究者

发起方
University of Brasilia
申办方类型
Other
责任方
Principal Investigator
主要研究者

João Luiz Q. Durigan

Physical Therapist Assistant Professor

University of Brasilia

研究点 (2)

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