Less is Better? Effectiveness of a Short Local Vibration Protocol on Neuromuscular Function

Обзор

Local vibration is a non-invasive neuromuscular stimulation modality used in training and rehabilitation for its effects on neuromuscular function, particularly its ability to induce nervous adaptations. Its passive application is particularly useful in cases of motor deficit or immobilization. Several studies, including our own, have shown that vibration protocols over several weeks can induce significant gains in muscle strength, particularly in the knee extensors. However, the parameters of application remain heterogeneous, particularly with regard to the duration of the interventions. With this in mind, a prospective controlled study is being conducted in healthy subjects, comparing four modalities of local vibration intervention targeting the knee extensors: an intensive vibration protocol over 5 consecutive days (1 session of 30 or 60 minutes per day) and a protocol spread over 4 weeks at a rate of 3 weekly sessions of 30 or 60 minutes). The objective is to evaluate and compare their immediate and delayed effects on force production and corticospinal properties. The results of this study will thus help optimize recommendations regarding the use of local vibration in muscle strengthening and neuromuscular reconditioning strategies.

Вмешательства

• Устройство Local vibration protocol
  The vibrations will be delivered using the Vibramoov Physio device, positioned directly on the quadriceps muscle. The participant will be seated comfortably and will remain at rest throughout the session. The vibration settings will be set to an amplitude of 1 mm and a frequency of 100 Hz.

Первичные конечные точки

• Compare the effect of the duration of a local vibration program (5 days vs 4 weeks), as well as the effect of the duration of the sessions (30 min vs 60 min) on the gain in knee extension strength in healthy volunteers. [Срок оценки: Five times: before the procedure (baseline); at the end of the procedure (day 21 or day 42 depending on the group); then 1 week (day 28 or day 49), 1 month (day 49 or day 70), and 3 months (day 105 or day 126) after the procedure.]

Вторичные конечные точки (7)

• Compare the effect of the duration of a local vibration program (5 days vs 4 weeks), as well as the effect of the duration of the sessions (30 min vs 60 min) on functional motor abilities and, more specifically, maximum voluntary strength [Срок оценки: Five times: before the intervention (baseline); at the end of the intervention (day 21 or day 42 depending on the group); then 1 week (day 28 or day 49), 1 month (day 49 or day 70) and 3 months (day 105 or day 126) after the intervention.]
• Compare the effect of the duration of a local vibration program (5 days vs 4 weeks), as well as the effect of the duration of the sessions (30 min vs 60 min) on functional motor skills and, more specifically, jumping performance. [Срок оценки: Five times: before the intervention (baseline); at the end of the intervention (day 21 or day 42 depending on the group); then 1 week (day 28 or day 49), 1 month (day 49 or day 70) and 3 months (day 105 or day 126) after the intervention.]
• Compare the effect of the duration of a local vibration program (5 days vs 4 weeks), as well as the effect of the duration of the sessions (30 min vs 60 min) on functional motor skills and, more specifically, the rate of force development (RFD) [Срок оценки: Five times: before the intervention (baseline); at the end of the intervention (day 21 or day 42 depending on the group); then 1 week (day 28 or day 49), 1 month (day 49 or day 70) and 3 months (day 105 or day 126) after the intervention.]
• Compare the effect of the duration of a local vibration program (5 days vs 4 weeks), as well as the effect of the duration of the sessions (30 min vs 60 min) on corticospinal properties and, more specifically, on the level of voluntary activation [Срок оценки: Five times: before the intervention (baseline); at the end of the intervention (day 21 or day 42 depending on the group); then 1 week (day 28 or day 49), 1 month (day 49 or day 70) and 3 months (day 105 or day 126) after the intervention.]
• Compare the effect of the duration of a local vibration program (5 days vs 4 weeks), as well as the effect of the duration of the sessions (30 min vs 60 min) on corticospinal properties and, more specifically, corticospinal excitability. [Срок оценки: Five times: before the intervention (baseline); at the end of the intervention (day 21 or day 42 depending on the group); then 1 week (day 28 or day 49), 1 month (day 49 or day 70) and 3 months (day 105 or day 126) after the intervention.]
• Compare the effect of the duration of a local vibration program (5 days vs 4 weeks), as well as the effect of the duration of the sessions (30 min vs 60 min) on corticospinal properties and, more specifically, spinal excitability [Срок оценки: Five times: before the intervention (baseline); at the end of the intervention (day 21 or day 42 depending on the group); then 1 week (day 28 or day 49), 1 month (day 49 or day 70) and 3 months (day 105 or day 126) after the intervention.]
• Compare the effect of the duration of a local vibration program (5 days vs 4 weeks), as well as the effect of the duration of the sessions (30 min vs 60 min) on corticospinal properties and, more specifically, cortical activation of sensorimotor areas. [Срок оценки: Five times: before the intervention (baseline); at the end of the intervention (day 21 or day 42 depending on the group); then 1 week (day 28 or day 49), 1 month (day 49 or day 70) and 3 months (day 105 or day 126) after the intervention.]

Критерии участия

Критерии включения

• Men and women,
• Aged between 18 and 45,
• With a body mass index between 18 and 30 kg/m²,
• Who have received detailed information about the study and have co-signed the consent form with the investigator,
• Who are affiliated with or entitled to social security coverage.

Критерии исключения

• Subjects with chronic cardiovascular, neuromuscular, bone, metabolic, and/or inflammatory conditions,
• Personal history and/or risk factors for thrombosis,
• Subjects undergoing antidepressant treatment,
• Subjects who have taken corticosteroid treatment in the last 3 months,
• Use of neuroactive substances likely to alter corticospinal excitability (hypnotics, antiepileptics, psychotropic drugs, muscle relaxants) during the study period,
• History of bone or ligament trauma to the lower limbs within the last 12 months,
• Unable to perform the physical efforts required for the study,
• Engaging in intense and unusual physical activity, including competitive sports, in the month preceding and during the protocol,
• Presence of a skin lesion at the site where the vibrator is to be placed,
• Simultaneous participation in another interventional medical trial,
• Pregnant and breastfeeding women
• Subjects unable to understand the purpose and conditions of the study, unable to give their consent,
• Subjects deprived of their liberty or subject to legal protection such as guardianship

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 1 центр

• CHU de Saint-Etienne — Saint-Etienne

Идентификаторы

NCT: NCT07344298 · 25CH170 · ANSM

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗