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The Influence of Passive Local Muscle Vibration on Mechanical Power Output and Neuromuscular Activity During Counterbalanced RPE-clamped Cycling: A Randomized Controlled Trial

14 luglio 2026 aggiornato da: Weronika Wozniak, Wrocław University of Science and Technology

The purpose of this study is to find out if applying mild mechanical vibration (100 Hz) to the the Achilles and patellar tendons before and during exercise can make cycling feel easier and help athletes generate more power. The researchers also want to test if a new, lightweight wearable sleeve called "Tendo" is just as effective at doing this as a stationary laboratory machine. The study will involve 40 healthy, active student-athletes aged 18 to 26. Each participant will attend three separate testing sessions in a laboratory, with at least 48 hours of rest between sessions. During each 85-minute session, participants will:

Complete baseline resting measurements of their muscles and tendons. Ride a stationary exercise bicycle with a covered screen, adjusting their speed and pedaling based only on how hard they feel they are working, using a 0-100 effort scale called Borg CR100.

Receive a 10-minute resting tendon vibration. Repeat the cycling test with a short "booster" vibration to see how their performance changes.

To understand how the vibration works, the researchers will use harmless skin sensors to measure muscle activity (sEMG), a gentle tapping device to check tendon stiffness (MyotonPRO), and ultrasound imaging to look at tendon structure.

Stationary Vibration: High-frequency (100 Hz) vibration from a fixed laboratory machine.

Wearable Vibration: High-frequency (100 Hz) vibration from the portable Tendo sleeve.

Sham Vibration: A low-frequency (15 Hz) vibration that does not trigger a physiological response, serving as a control to make sure the results are not just due to a placebo effect.

Panoramica dello studio

Descrizione dettagliata

The perception of physical exertion (RPE - Rate of Perceived Exertion), most commonly quantified using the Borg scale, constitutes a key neurophysiological mechanism regulating the intensity and duration of human locomotor activity. Traditional models of peripheral fatigue assumed that the exercise capacity limit is directly determined by the homeostatic depletion of muscular energy reserves. However, contemporary sports neurophysiology, drawing on the concept of the Central Governor Model, demonstrates that the central nervous system is the ultimate guardian of human performance.

In this context, a crucial role is played by the phenomena of proprioception and somatosensory signaling generated by musculo-tendinous mechanoreceptors, specifically muscle spindles. These spindles are sensitive to changes in muscle length and the rate of these changes, sending continuous feedback to the CNS via the ascending pathways of the spinal cord. The brain compares these signals with an internal template of motor intention, the so-called efference copy, which serves as a neurological equivalent of the expected energetic expenditure. The convergence or divergence of these two information streams directly shapes the final perception of RPE. Studies from last year (Marchand et al., 2025), upon which our medical experiment is based, proved that this mechanism can be effectively modulated non-pharmacologically using passive, high-frequency mechanostimulation. Applying mechanical vibrations with a frequency of 100 Hz and an amplitude of approximately 1 mm to the tendons induces a phenomenon of neurophysiological receptor jamming. The intense vibration triggers a torrent of proprioceptive impulses, leading to the suppression of spinal reflexes and the attenuation of reaferent signals sent from the muscle spindles to the brain. Consequently, the CNS interprets the movement as "energetically cheaper" and easier. Laboratory studies indicate that decoupling the actual mechanical load from the perception of exertion allows for an increase in actual power output (by up to approximately 20% during submaximal effort) without a simultaneous increase in the subjective feeling of fatigue. Moreover, vibration exhibits protective properties against neuromuscular fatigue, stabilizing exercise parameters in the late stages of training.

This project aims to translate these fundamental laboratory discoveries into applied conditions. Previous research protocols relied on stationary, electrodynamic exciters that required complete immobilization of the subject's limb and the application of vibration in a specific position while stabilizing the exciter, which limited their utility in sports. The answer to this limitation is an interdisciplinary project by the Wrocław University of Science and Technology - a proprietary prototype of the Tendo wearable vibration band. By applying physical parameters identical to laboratory equipment (100 Hz), this device offers full mobility and makes this technology accessible to every athlete.

To precisely verify the research hypothesis and determine the basis of the observed changes, the project involves a three-dimensional diagnostic approach combining neurological, biomechanical, and structural assessments.

The project's results have the potential to revolutionize training support methods, optimize post-exercise neuromuscular recovery, and protect athletes from musculoskeletal overloads, offering the academic and sporting communities a fully safe, scientifically validated, and mobile stimulation tool.

Link to the study upon which we base our work: https://doi.org/10.1016/j.jshs.2025.101061 .

This study is designed as an interdisciplinary, randomized, single-blind, three-arm, counterbalanced crossover trial. The primary objective is to investigate the translation of focal muscle vibration from a stationary laboratory setup to a flexible, low-voltage wearable sleeve (Tendo). Each of the 40 recruited student-athletes will complete three distinct experimental sessions separated by a washout period of at least 48 hours to prevent neuromuscular carryover effects.

Prior to the experimental sessions, participants will attend an online briefing session to learn about the rating of perceived exertion (RPE) using the Borg CR100 scale, distinguishing exertion from muscle pain or discomfort. Following this, they will undergo a physical familiarization session involving a mock incremental test on a cycle ergometer. Group allocation and session order will be determined before the first experimental session using a simple service randomisation via sealedenvelope.com.

sEMG Preparation: Skin over the vastus lateralis muscle of the dominant limb will be shaved, abraded, and cleaned to reduce impedance, in accordance with SENIAM guidelines. Wireless Shimmer3 EMG electrodes will be secured using hypoallergenic gel electrodes and additionally reinforced with medical adhesive tape to prevent detachment due to intense sweating.

Statical ultrasound imaging of the Achilles tendon and patellar ligament will be performed under direct orthopedic supervision. Viscoelastic and biomechanical tissue properties (static tone, dynamic stiffness, and elasticity) will be recorded using the MyotonPRO digital myotonometer.

Participants perform a standardized 6-minute warm-up on a cycle ergometer (4 minutes at moderate self-selected intensity, followed by 2 minutes at strong intensity).

A baseline exercise test is conducted on the cycle ergometer to establish pre-intervention power output values.

Participants rest in a seated position for 12 minutes. For exactly 10 minutes, bilateral focal muscle vibration (100 Hz, 1 mm amplitude) or sham stimulation (15 Hz, 1 mm amplitude) is applied directly to the Achilles and patellar tendons.

During stimulation, participants maintain a 90° flexion at the hip and knee joints, with the ankle in dorsiflexion, ensuring optimal muscle-tendon tension for maximum vibration transmission to the muscle spindles.

Immediately post-exercise and at minutes 15 and 30 of resting recovery, the baseline measurements (MyotonPRO, USG, and static sEMG) are repeated.

Relative percentage changes from baseline (Relative change% = [(Post - Pre) / Pre] * 100%) will be calculated for all biomechanical and neuromuscular parameters.

Safety and Termination Criteria

The study will be immediately terminated for any participant who:

Formally withdraws consent, Reports acute joint/muscle pain, chest tightness, severe dizziness, or nausea, Reaches volitional exhaustion, Exhibits abnormal physiological responses (e.g., erratic heart rate spikes), Experiences any technical malfunction with the stimulation devices,

Tipo di studio

Interventistico

Iscrizione (Stimato)

40

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Polonia, 50-370
        • Medical Simulation Center, Faculty of Medicine, Wroclaw University of Science and Technology

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

Sì

Descrizione

Inclusion Criteria:

  • Age between 18 and 26 years
  • Active student or doctoral student status at a higher education institution
  • Active participation in sports training (endurance or mixed disciplines, e.g., cycling, running, triathlon, team sports) with a minimum frequency of 3 times per week, verified by a recruitment questionnaire.
  • Good general health, with no medical contraindications to performing intense exercise testing on a cycle ergometer.
  • Normal anatomical condition of the Achilles tendon and patellar ligament during baseline screening - no history of acute inflammation or ruptures.
  • Provision of voluntary, written informed consent to participate in the study and for medical data processing.

Exclusion Criteria:

  • Orthopedic and structural contraindications: Recent injuries in less than 6 months, joint ruptures, or surgical interventions in the lower limbs; chronic or acute inflammation of the Achilles tendon or patellar ligament; presence of metal implants or joint replacements in the stimulated limbs.
  • Neurological contraindications: Diagnosed epilepsy or susceptibility to seizures, superficial or deep sensory impairment such as neuropathy, radiculopathy, that could impair stimulus evaluation or risk tissue damage.
  • Cardiovascular contraindications: Diagnosed heart defects, unstable arterial hypertension, cardiac arrhythmias; presence of a pacemaker or implantable cardioverter-defibrillator, active thromboembolic diseases, deep vein thrombosis, or severe varicose veins of the lower limbs.
  • General medical contraindications: Pregnancy; active oncological diseases; active infections or fever on the day of testing; dermatological changes, open wounds, or skin ulcers at the planned application sites of sEMG electrodes or Tendo vibration sleeves.
  • Other: Regular intake of medications or substances that affect the threshold of pain or fatigue perception (e.g., strong analgesics, steroids, or pre-workout supplements containing high amounts of stimulants taken directly before the test).

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Scienza basilare
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Wearable Vibration
Participants receive muscle vibration delivered via wearable Tendo device. The vibration is applied bilaterally to the Achilles and patellar tendons with a frequency of 100 Hz and an amplitude of 1 mm. This condition consists of a 10-minute resting pre-exercise stimulation followed by a 5-minute "booster" stimulation administered dynamically during movement midway through the cycling protocol to sustain the neurophysiological Tonic Vibration Reflex (TVR).
Arm Description: Participants receive focal muscle vibration delivered via a lightweight, wearable Tendo system. The vibration is applied bilaterally to the Achilles and patellar tendons with a frequency of 100 Hz and an amplitude of 1 mm. This condition consists of a 10-minute resting pre-exercise stimulation followed by a 5-minute "booster" stimulation administered dynamically during movement midway through the cycling protocol to sustain the neurophysiological Tonic Vibration Reflex (TVR).
Participants undergo an identical protocol but receive a low-frequency, non-therapeutic sham stimulation. The stimulation is applied bilaterally to the Achilles and patellar tendons via the Tendo sleeve with a subminimal frequency of 15 Hz and an amplitude of 1 mm. This condition consists of a 10-minute resting pre-exercise sham stimulation followed by a 5-minute booster sham stimulation during the active cycling protocol to control for the acoustic noise, physical presence of the device, and potential placebo effects.
Participants receive focal muscle vibration delivered via a stationary laboratory device. The vibration is applied bilaterally to the Achilles and patellar tendons with a frequency of 100 Hz and an amplitude of 1 mm. This condition consists of a 10-minute resting pre-exercise stimulation followed by a 5-minute resting "booster" stimulation administered midway through the cycling protocol to sustain the neurophysiological Tonic Vibration Reflex (TVR).
Comparatore attivo: Laboratory Vibration (Active Control Reference)
Participants receive focal muscle vibration delivered via alabpooratory device. The vibration is applied bilaterally to the Achilles and patellar tendons with a frequency of 100 Hz and an amplitude of 1 mm. This condition consists of a 10-minute resting pre-exercise stimulation followed by a 5-minute resting "booster" stimulation administered midway through the cycling protocol to sustain the neurophysiological Tonic Vibration Reflex (TVR).
Arm Description: Participants receive focal muscle vibration delivered via a lightweight, wearable Tendo system. The vibration is applied bilaterally to the Achilles and patellar tendons with a frequency of 100 Hz and an amplitude of 1 mm. This condition consists of a 10-minute resting pre-exercise stimulation followed by a 5-minute "booster" stimulation administered dynamically during movement midway through the cycling protocol to sustain the neurophysiological Tonic Vibration Reflex (TVR).
Participants undergo an identical protocol but receive a low-frequency, non-therapeutic sham stimulation. The stimulation is applied bilaterally to the Achilles and patellar tendons via the Tendo sleeve with a subminimal frequency of 15 Hz and an amplitude of 1 mm. This condition consists of a 10-minute resting pre-exercise sham stimulation followed by a 5-minute booster sham stimulation during the active cycling protocol to control for the acoustic noise, physical presence of the device, and potential placebo effects.
Participants receive focal muscle vibration delivered via a stationary laboratory device. The vibration is applied bilaterally to the Achilles and patellar tendons with a frequency of 100 Hz and an amplitude of 1 mm. This condition consists of a 10-minute resting pre-exercise stimulation followed by a 5-minute resting "booster" stimulation administered midway through the cycling protocol to sustain the neurophysiological Tonic Vibration Reflex (TVR).
Comparatore fittizio: Sham Stimulation
Participants undergo an identical protocol but receive a low-frequency, non-therapeutic sham stimulation. The stimulation is applied bilaterally to the Achilles and patellar tendons via the Tendo device with a subminimal frequency of 15 Hz and an amplitude of 1 mm. This condition consists of a 10-minute resting pre-exercise sham stimulation followed by a 5-minute booster sham stimulation during the active cycling protocol to control for the acoustic noise, physical presence of the device, and potential placebo effects.
Arm Description: Participants receive focal muscle vibration delivered via a lightweight, wearable Tendo system. The vibration is applied bilaterally to the Achilles and patellar tendons with a frequency of 100 Hz and an amplitude of 1 mm. This condition consists of a 10-minute resting pre-exercise stimulation followed by a 5-minute "booster" stimulation administered dynamically during movement midway through the cycling protocol to sustain the neurophysiological Tonic Vibration Reflex (TVR).
Participants undergo an identical protocol but receive a low-frequency, non-therapeutic sham stimulation. The stimulation is applied bilaterally to the Achilles and patellar tendons via the Tendo sleeve with a subminimal frequency of 15 Hz and an amplitude of 1 mm. This condition consists of a 10-minute resting pre-exercise sham stimulation followed by a 5-minute booster sham stimulation during the active cycling protocol to control for the acoustic noise, physical presence of the device, and potential placebo effects.
Participants receive focal muscle vibration delivered via a stationary laboratory device. The vibration is applied bilaterally to the Achilles and patellar tendons with a frequency of 100 Hz and an amplitude of 1 mm. This condition consists of a 10-minute resting pre-exercise stimulation followed by a 5-minute resting "booster" stimulation administered midway through the cycling protocol to sustain the neurophysiological Tonic Vibration Reflex (TVR).

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mean Power Output
Lasso di tempo: Continuous recording at 1 Hz, analyzed as the mean power output for each 3-minute block during the cycling task (specifically comparing blocks across the three experimental sessions).
The mean power output (measured in Watts) generated by the participant during the submaximal cycling task. The task is clamp-controlled based on a constant, pre-determined rate of perceived exertion (RPE) on the Borg CR100 scale. Since the perception of effort is kept constant (clamped), the changes in generated power output will reflect the actual physiological and performance efficacy of the focal muscle vibration compared to the sham condition.
Continuous recording at 1 Hz, analyzed as the mean power output for each 3-minute block during the cycling task (specifically comparing blocks across the three experimental sessions).

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Neuromuscular Activity
Lasso di tempo: Continuous recording during the cycling task, and static recordings with isometric contraction and with no contraction at baseline, immediately post-exercise, 15 minutes, and 30 minutes of recovery.
Root Mean Square (RMS) of the surface electromyography (sEMG) signal recorded from the vastus lateralis muscle. This parameter assesses changes in neuromuscular excitability, muscle spindle afferent attenuation, and motor unit recruitment strategies.
Continuous recording during the cycling task, and static recordings with isometric contraction and with no contraction at baseline, immediately post-exercise, 15 minutes, and 30 minutes of recovery.
Biomechanical and Viscoelastic Tissue Properties
Lasso di tempo: Recorded at baseline, immediately post-exercise, 15 minutes, and 30 minutes of recovery.
Dynamic stiffness, static tone, and logarithmic decrement of the Achilles tendon and patellar ligament measured non-invasively using the MyotonPRO digital myotonometer. This evaluates whether focal vibration alters the intrinsic mechanical properties of the tissue or works purely through neural pathways.
Recorded at baseline, immediately post-exercise, 15 minutes, and 30 minutes of recovery.

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Tendon Morphological Structure (Ultrasound)
Lasso di tempo: Recorded at baseline, immediately post-exercise, 15 minutes, and 30 minutes of recovery.
Cross-sectional area and structural echogenicity of the Achilles tendon and patellar ligament measured via real-time musculoskeletal ultrasound to monitor immediate morphological responses to mechanical stimulation.
Recorded at baseline, immediately post-exercise, 15 minutes, and 30 minutes of recovery.
Physiological and Kinematic Strain
Lasso di tempo: Continuous recording during cycling task, recorded at baseline, immediately post-exercise, 15 minutes, and 30 minutes of recovery.
Heart rate measured in beats per minute via Polar H10 chest strap and pedaling cadence measured in revolutions per minute via ergometer. These metrics assess physiological cost and movement efficiency under constant perceived exertion.
Continuous recording during cycling task, recorded at baseline, immediately post-exercise, 15 minutes, and 30 minutes of recovery.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Direttore dello studio: Szymon L Dragan, MD, PhD, Assoc. Prof., Faculty of Medicine, Wroclaw University of Science and Technology

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

15 luglio 2026

Completamento primario (Stimato)

30 agosto 2026

Completamento dello studio (Stimato)

30 settembre 2026

Date di iscrizione allo studio

Primo inviato

14 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

14 luglio 2026

Primo Inserito (Effettivo)

20 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

20 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

14 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

De-identified individual participant data, including physiological, biomechanical, and neuromuscular parameters that underlie the results reported in future publications will be made available to academic researchers to facilitate scientific collaboration and validation of the findings.

Periodo di condivisione IPD

The de-identified individual participant data and supporting documents (such as the study protocol and informed consent template) will become available immediately following the official publication of the primary manuscript in a peer-reviewed journal. These data will remain accessible for a period of 36 months (3 years) from the publication date.

Criteri di accesso alla condivisione IPD

Access will be restricted to qualified academic researchers and clinicians affiliated with recognized research institutions or universities who provide a methodologically sound research proposal. Approved applicants will receive access to the fully de-identified raw individual participant data including sEMG, MyotonPRO, and biomechanical parameters along with the blank informed consent form and study protocol. To request access, researchers must contact the corresponding author via their institutional email address. Requests will be evaluated by the study's scientific leadership. If approved, data will be shared via a secure, encrypted data transfer service after both parties sign a formal Data Use Agreement (DUA) to ensure participant confidentiality is strictly maintained.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF
  • CODICE_ANALITICO
  • RSI

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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