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Recruiting NCT07021079

Muscle Vibration as a Countermeasure Against Hypoactivity-induced

No phase Interventional Vibration Therapy Healthy Volunteer Study Hypoactivity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Focal muscle vibration, NO Focal muscle vibration.
Who it may be relevant to
Registry conditions: Vibration Therapy, Healthy Volunteer Study, Hypoactivity. Basic parameters: 19 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Device Focal muscle vibration
    focal muscle vibration sessions, using small and portable vibrator devices.
  • Device NO Focal muscle vibration
    The control group will not receive any intervention.

Primary outcome measures

  • Isometric force measurement [Time frame: Day 1, 7, 14, 28, 33]
Secondary outcome measures (12)
  • Maximum voluntary force measurement [Time frame: Day 1, 7, 14, 28, 33]
  • Jumping performance measurement [Time frame: Day 1, 7, 14, 28, 33]
  • Postural balance measurement [Time frame: Day 1, 7, 14, 28, 33]
  • Neuromuscular fatigue measurement [Time frame: Day 1, 7, 14, 28, 33]
  • Force-velocity-endurance measurement [Time frame: Day 1, 7, 14, 28, 33]
  • Voluntary activation level evaluation [Time frame: Day 1, 7, 14, 28, 33]
  • Cortico-spinal excitability measurement [Time frame: Day 1, 7, 14, 28, 33]
  • Spinal excitability evaluation [Time frame: Day 1, 7,14 , 28, 33]
  • Cortical activation of sensorimotor areas measurement [Time frame: Day 1, 7, 14, 28, 33]
  • Muscle volume measurement [Time frame: Day 1, 7, 14, 28, 33]
  • Determination of plasma molecular markers of bone and muscle remodeling [Time frame: Day 1, 7, 14, 28, 33]
  • Determination of plasma molecular markers of bone and muscle remodeling [Time frame: Day 1, 7, 14, 28, 33]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

France · 1 center
  • Centre Hospitalier Universitaire — Saint-Etienne

Identifiers

NCT: NCT07021079 · 24CH295 · 2024-A02769-38

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗