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临床试验/NCT07021079
NCT07021079招募中不适用

Effects of Focal Muscle Vibration as a Countermeasure Against Hypoactivity-induced Neuromuscular Deconditioning

Centre Hospitalier Universitaire de Saint Etienne1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2025年6月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
42
试验地点
1
主要终点
Isometric force measurement

研究概览

简要总结

Muscle deconditioning, characterized by a loss of muscle mass and strength, is a frequent consequence of prolonged lower limb unloading. Beyond muscle mass loss, reduced neural drive contributes significantly to strength decline, highlighting the need for interventions targeting neuromuscular function during immobilization. Focal muscle vibration (FMV) has shown promise in modulating neuromuscular excitability by activating muscle spindle afferents and inducing cortical adaptations. Chronic use of FMV has been associated with significant strength gains and improved neural command. This makes FMV an effective rehabilitation tool. Its simplicity and non-invasiveness further make it a practical countermeasure.

详细描述

This study hypothesizes that a 10-day FMV protocol can induce neural adaptations to limit strength loss during unilateral lower limb suspension, offering a novel strategy against neuromuscular function decline.

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
None

入排标准

年龄范围
19 Years 至 45 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Men and women.
  • •Aged 18 to 45 years.
  • •Body Mass Index (BMI) between 18,5 and 24,9 kg/m².
  • •Engaging in at least 1.5 hours per week of physical activity (e.g., brisk walking, running, swimming, cycling).
  • •Provided informed consent after receiving detailed information about the study.
  • •Affiliated with or beneficiaries of a social security system

排除标准

  • •Chronic cardiovascular, neuromuscular, bone, metabolic, and/or inflammatory disorders.
  • •Personal history and/or risk factors for thrombosis.
  • •Use of antidepressant medications.
  • •Use of neuroactive substances likely to alter corticospinal excitability (e.g., hypnotics, antiepileptics, psychotropics, muscle relaxants) during the study.
  • •Recent bone or ligament trauma within the past 12 months.
  • •Inability to perform the physical efforts required for the study.
  • •Recent participation in a sporting competition or intense, unusual physical activity within the past month.
  • •Corticosteroid treatment within the past 3 months.
  • •Any skin lesions at the planned vibrator application site.
  • •Simultaneous participation in another interventional medical study.
  • •Pregnant or breastfeeding women.
  • •Individuals unable to understand the purpose and conditions of the study or unable to provide informed consent.
  • •Individuals deprived of liberty or under guardianship

研究组 & 干预措施

CONTROLE

Sham Comparator

the control group WILL not receive this countermeasure.

干预措施: NO Focal muscle vibration (Device)

VIBRATION

Active Comparator

Participants will benefit a local vibration countermeasure program for the knee extensor muscles.

干预措施: Focal muscle vibration (Device)

结局指标

主要结局

Isometric force measurement

时间窗: Day 1, 7, 14, 28, 33

Maximal isometric force (% decrease) in knee extension of the immobilized leg will be evaluated

次要结局

  • Determination of plasma molecular markers of bone and muscle remodeling(Day 1, 7, 14, 28, 33)
  • Cortical activation of sensorimotor areas measurement(Day 1, 7, 14, 28, 33)
  • Muscle volume measurement(Day 1, 7, 14, 28, 33)
  • Maximum voluntary force measurement(Day 1, 7, 14, 28, 33)
  • Jumping performance measurement(Day 1, 7, 14, 28, 33)
  • Postural balance measurement(Day 1, 7, 14, 28, 33)
  • Neuromuscular fatigue measurement(Day 1, 7, 14, 28, 33)
  • Force-velocity-endurance measurement(Day 1, 7, 14, 28, 33)
  • Voluntary activation level evaluation(Day 1, 7, 14, 28, 33)
  • Cortico-spinal excitability measurement(Day 1, 7, 14, 28, 33)
  • Spinal excitability evaluation(Day 1, 7,14 , 28, 33)
  • Plasma molecular markers of thrombotic risk evaluation(Day 1, 7, 14, 28, 33)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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