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临床试验/NCT05500300
NCT05500300Unknown不适用

Effects on Isometric Force Induction, Tolerance and Fatigue of Neuromuscular Electrical Stimulation and High Intensity Focused Electromagnetic Field in Healthy Subjects

Maimonides University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年8月22日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
2
主要终点
Maximal Voluntary Isometric Contraction (MVIC)

研究概览

简要总结

Muscle strength is the amount of force generated by muscle contraction. It could be measured with an isometric dynamometer. This is a validated tool that could be used to measure Maximal Voluntary Isometric Contraction (MVIC) and Maximal Electrical Induced Contraction (MEIC). It is claimed that higher MEIC values will result in more force gained.

If a current is more tolerated it will be easier to achieve better MEIC values. Tolerance to an electrical stimulation could be measured with the Visual Analogue Scale (VAS). A ratio between Normalized MEIC / VAS is often used, implying that the current is better with a higher ratio.

Muscle fatigue is defined as a temporary loss or decrease in force-generating ability due to previous contractions. It is claimed that medium frequency neuromuscular electrical stimulation (NMES) generates more fatigue than low frequency currents.

Aussie is a medium-frequency alternating current, sinusoidal waveform, 1 KHz carrier frequency.

Neo-Russian is a medium-frequency current, rectangular biphasic symmetrical waveform, 2,5 KHz carrier frequency.

Rectangular Biphasic symmetrical (RBS) waveform is a type of Low Pulsed Current (LPC), claimed to be better than classical Russian Current.

Purpose:

As it has been claimed that LPC is better in MEIC and tolerance, the aim of this study is to compare it with two newer medium frequency currents in terms of MEIC, tolerance and fatigue.

Methods:

Thirty male subjects, right leg dominant, will receive randomly the 3 types of electrical stimulation. Before that, the MVIC will be measured for data normalization.

The MVIC and MEIC will be measured with an isometric dynamometer. In both measurements, subjects will be asked to perform three reps (5 sec work x 120 sec rest) and the best one will be used. Whenever the third one was the best, additional measurements will be taken until a decrease in torque will be obtained to determine the maximum.

To apply Aussie electrical stimulation, an Aussie Sport (Ibramed) will be used. To apply Neo-Russian, a Neurodyn III (Ibramed) will be used. To apply RBS, a Genesy (Globus) will be used.

The VAS will be used to assess tolerance to each treatment. One week later, the subjects will receive, randomly, a fatigue protocol that consists in 21 reps (5 sec work x 5 sec rest) of electrical stimulation with the three types of current. The data will be normalized with the MVIC and the reps equal or below 50 % of the first rep will be considered as a fatigue rep.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Quadruple (Participant, Care Provider, 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

  • Healthy volunteers
  • Right leg dominant
  • Exercising regularly

排除标准

  • History of injuries in the right leg
  • Skin lesions
  • Having a pacemaker
  • Having a cardiovascular disease.
  • Having a neurological disorder.
  • Exercise 72 h before the procedure.

结局指标

主要结局

Maximal Voluntary Isometric Contraction (MVIC)

时间窗: Day 1

Force generated by the patient during a maximal voluntary isometric contraction, measured by an isometric dynamometer with load cell and computer interface. The best of the 3 repetitions will be considered. Whenever the third one is the best, additional measurements will be taken until a decrease in torque is obtained in order to determine the maximum. Unit: Newtons (N)

Maximal Electrical Induced Contraction (MEIC)

时间窗: Day 1

Force generated in the muscle while applying electrical stimulation and HIFEM, measured by an isometric dynamometer with load cell and computer interface. This data (in Newtons) will be normalized with the MVIC. Unit: percentage of MVIC

Visual Analogue Scale

时间窗: Day 1

Visual Analogue Scale (VAS): Magnitude of pain, marked in a analogue scale by participants, to determine how unpleasant is each type of stimulation (applied in randomized order). Expresed in centimeters. * Minimum value: 0 * Maximum value: 10 * A higher score implicates a worse outcome. VAS wil be evaluated 5 times, 1 per type of stimulation.

次要结局

  • Fatigue index(Day 7)

研究者

发起方
Maimonides University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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