Muscle FatigueNCT07715292
The Influence of Passive Local Muscle Vibration on Mechanical Power Output and Neuromuscular Activity During Counterbalanced RPE-clamped Cycling: A Randomized Controlled Trial
A study testing Tendo device Vibrration in people with Muscle Fatigue and Exertion, Perceived, run by Wrocław University of Science and Technology at 1 site in Poland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Fatigue, Exertion, Perceived, Neuromuscular Activity
- What is being tested?
- Tendo device Vibrration
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 sitePoland
- Study dates
- 15 Jul 2026to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 26 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site
Medical Simulation Center, Faculty of Medicine, Wroclaw University of Science and Technology
Wroclaw, Lower Silesian Voivodeship, 50-370
About this study
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.
Read more
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.
Read the detailed description
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,
- Being tested
- Tendo device Vibrration, Sham Muscle Vibration, Laboratory control vibration
- Keywords
- Focal Muscle Vibration, Tendon Vibration, Rate of Perceived Exertion, BorgCR100, RPE-clamped, Cycling Performance, Tonic Vibration Reflex, Electromyography, Myotonometry, Wearable Technology, Sports Science, Neuromuscular Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tendo device VibrrationDevice
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).
Sham Muscle VibrationDevice
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.
Laboratory control vibrationDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Wearable Vibration | Experimental | 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). Receives: Device: Tendo device Vibrration; Device: Sham Muscle Vibration; Device: Laboratory control vibration |
| Laboratory Vibration (Active Control Reference) | Active comparator | 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). Receives: Device: Tendo device Vibrration; Device: Sham Muscle Vibration; Device: Laboratory control vibration |
| Sham Stimulation | Sham comparator | 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. Receives: Device: Tendo device Vibrration; Device: Sham Muscle Vibration; Device: Laboratory control vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Power Output
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.
Measured: 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).
Secondary outcomes (2)
Neuromuscular Activity
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.
Measured: 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
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.
Measured: Recorded at baseline, immediately post-exercise, 15 minutes, and 30 minutes of recovery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start15 Jul 2026 (estimated)
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscle FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a randomized, counterbalanced, single-blind, three-arm crossover study. Each participant completes all three experimental conditions: 100 Hz stationary laboratory vibration, 100 Hz wearable vibration (Tendo sleeve), and 15 Hz subminimal sham stimulation. The order of the sessions is randomized for each participant prior to the first visit using a randomization generator sealedenvelope.com to eliminate systematic bias. A washout period of at least 48 hours is enforced between sessions to allow complete neuromuscular recovery and prevent any carryover effects.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wrocław University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weronika Wozniak, Wrocław University of Science and Technology
- Investigators
- Szymon L Dragan, MD, PhD, Assoc. Prof., Study director, Faculty of Medicine, Wroclaw University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07715292
- Sponsor's protocol ID
- 28/12/KBPWr/EM_26/2024-2027
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Marchand F, Pageaux B, Forestier N, Monjo F. Prolonged passive vibration of Achilles and patellar tendons decreases effort perception during subsequent cycling tasks. J Sport Health Sci. 2025 Dec;14:101061. doi: 10.1016/j.jshs.2025.101061. Epub 2025 May 24.
PubMed 40419138
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Passive Local Muscle Vibration on Mechanical Power Output and Neuromuscular Activity During Counterbalanced RPE-clamped Cycling: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07715292
- Acronym / sponsor ID
- 28/12/KBPWr/EM_26/2024-2027
- Keywords
- Focal Muscle Vibration, Tendon Vibration, Rate of Perceived Exertion, BorgCR100, RPE-clamped, Cycling Performance, Tonic Vibration Reflex, Electromyography
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Wrocław University of Science and TechnologyUniversity, hospital or other
- Study start
- 15 Jul 2026 (estimated)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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,
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- This is a randomized, counterbalanced, single-blind, three-arm crossover study. Each participant completes all three experimental conditions: 100 Hz stationary laboratory vibration, 100 Hz wearable vibration (Tendo sleeve), and 15 Hz subminimal sham stimulation. The order of the sessions is randomized for each participant prior to the first visit using a randomization generator sealedenvelope.com to eliminate systematic bias. A washout period of at least 48 hours is enforced between sessions to allow complete neuromuscular recovery and prevent any carryover effects.
| Arm | Type | Receives |
|---|---|---|
| Wearable Vibration | Experimental | Device: Tendo device Vibrration, Device: Sham Muscle Vibration, Device: Laboratory control vibrationParticipants 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). |
| Laboratory Vibration (Active Control Reference) | Active comparator | Device: Tendo device Vibrration, Device: Sham Muscle Vibration, Device: Laboratory control vibrationParticipants 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). |
| Sham Stimulation | Sham comparator | Device: Tendo device Vibrration, Device: Sham Muscle Vibration, Device: Laboratory control vibrationParticipants 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. |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tendo device VibrrationArm 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). | Device | Laboratory Vibration (Active Control Reference), Sham Stimulation, Wearable Vibration |
| Sham Muscle VibrationParticipants 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. | Device | Laboratory Vibration (Active Control Reference), Sham Stimulation, Wearable Vibration |
| Laboratory control vibrationParticipants 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). | Device | Laboratory Vibration (Active Control Reference), Sham Stimulation, Wearable Vibration |
Primary outcome
Mean Power Output
Time frame: 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.
2 secondary outcomes
Neuromuscular Activity
Time frame: 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
Time frame: Recorded at baseline, immediately post-exercise, 15 minutes, and 30 minutes of recovery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Results publication: PubMed 40419138Marchand F, Pageaux B, Forestier N, Monjo F. Prolonged passive vibration of Achilles and patellar tendons decreases effort perception during subsequent cycling tasks. J Sport Health Sci. 2025 Dec;14:101061. doi: 10.1016/j.jshs.2025.101061. Epub 2025 May 24.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Szymon L Dragan, MD, PhD, Assoc. Prof. study director
Faculty of Medicine, Wroclaw University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tendo device Vibrration in people with Muscle Fatigue and Exertion, Perceived, run by Wrocław University of Science and Technology at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Power Output (time frame: 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07715292, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.