- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07715292
The Influence of Passive Local Muscle Vibration on Mechanical Power Output and Neuromuscular Activity During Counterbalanced RPE-clamped Cycling: A Randomized Controlled Trial
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.
Aperçu de l'étude
Statut
Intervention / Traitement
Description détaillée
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,
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Lower Silesian Voivodeship
-
Wroclaw, Lower Silesian Voivodeship, Pologne, 50-370
- Medical Simulation Center, Faculty of Medicine, Wroclaw University of Science and Technology
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
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).
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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).
|
|
Comparateur actif: 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).
|
|
Comparateur factice: 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).
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Mean Power Output
Délai: 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).
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Neuromuscular Activity
Délai: 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
Délai: 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.
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Tendon Morphological Structure (Ultrasound)
Délai: 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
Délai: 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.
|
Collaborateurs et enquêteurs
Les enquêteurs
- Directeur d'études: Szymon L Dragan, MD, PhD, Assoc. Prof., Faculty of Medicine, Wroclaw University of Science and Technology
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 28/12/KBPWr/EM_26/2024-2027
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Délai de partage IPD
Critères d'accès au partage IPD
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
- ANALYTIC_CODE
- RSE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .