Vibration; ExposureNCT05478447
Sympathetic Stress and Whole Body Vibration Reflex
A study testing Vibration in people with Vibration; Exposure and Muscle Physiology, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Whole body vibration (WBV) is a therapeutic modality in the form of exercise on a vibrating platform with an amplitude of 2-4 mm at a frequency of 25-50 Hz, which is used with increased popularity in sports medicine and rehabilitation due to its beneficial effects on muscle strength, balance, postural control, bone… Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Vibration; Exposure, Muscle Physiology
- What is being tested?
- Vibration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Sep 2022to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Being healthy
- Being a young adult (20-45 years old)
- Volunteer
- Male
Who cannot join
- Scar, dermatitis, etc. in the skin tissue where EMG electrodes will be placed
- Kidney stone history
- Fracture in the lower extremity, history of orthopedic surgery
- Heart disease, Hypertension
- Dizziness
- Metabolic bone diseases, including osteoporosis
Show all 12Show fewer
- History of bone occupying lesion, neoplasia, osteomyelitis
- Degenerative, inflammatory diseases of the joints of the lower extremities
- Lower extremity thrombophlebitis
- Lower extremity motor loss, sensory loss, muscle atrophy
- Cold allergy
- Subjects who cannot tolerate whole-body vibration
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Physical Medicine Rehabilitation Training & Research Hospital
Istanbul, 34173
About this study
Official title: Effect of Sympathetic Stress on Whole Body Vibration Reflex
Whole body vibration (WBV) is a therapeutic modality in the form of exercise on a vibrating platform with an amplitude of 2-4 mm at a frequency of 25-50 Hz, which is used with increased popularity in sports medicine and rehabilitation due to its beneficial effects on muscle strength, balance, postural control, bone formation, and circulation. Beneficial effects on muscle strength and athletic performance have been reported. Spinal reflexes explain these beneficial neuromuscular effects. However, the neuronal circuit and receptors of the reflex response have not been defined precisely. A group of researchers propose that the reflex system underlying the neuromuscular effects of WBV is the Tonic vibration reflex (TVR), whose receptor is the muscle spindle; other researchers claim that the reflex latency induced by WBV is 4-5 ms longer than the TVR latency, so it is a bone myoregulation reflex whose receptor is osteocytes.
The muscle spindle has sympathetic innervation. It has been reported that in case of increased sympathetic activity, muscle spindle sensitivity may increase and short-latency stretch reflex may be facilitated. The variation of muscle spindle activity with sympathetic activity may provide an opportunity to define the nature of the reflex response during WBV. Muscle spindles are more sensitive to vibrations around 100 Hz. This study has two hypotheses: According to the first hypothesis, WBV activates muscle spindles and the reflex latency induced by WBV is the same as TVR latency, and the latency does not change with increased sympathetic activity. According to the alternative hypothesis, WBV activates osteocytes, and WBV-induced reflex latency is longer than TVR latency. With increased sympathetic activity, the WBV reflex becomes dominant and the WBV-induced reflex latency becomes shorter. The aim of this research is to determine which of these two hypotheses is valid.
Read the detailed description
22 healthy males between the ages of 20 and 45 will be recruited for this study. All subjects will receive pre-study informed consent. All experimental procedures were designed with the Helsinki declaration in mind and approved by the local ethics committee. In all subjects, whole body vibration(WBV) and isolated tendon vibration will be applied before, after, and during sympathetic activation maneuvers. Reflex responses induced by WBV and isolated tendon vibration will be recorded by surface electromyography (EMG) from the right soleus muscle. Latency calculation will be made using the "Cumulative averaging method".
Mental arithmetic task and cold stress test will be applied as sympathetic activation maneuver. For the mental arithmetic task, the subject is asked to mentally subtract a two-digit number from a four-digit number and respond within five seconds. This arithmetic calculation is repeated for different numbers. This test is continued for two minutes. For the cold stimulation test, subjects are asked to dip their right hand into 2-4 degrees cold water up to the elbow and hold it in the water for two minutes. At this time, either WBV or tendon vibration will be applied. After a ten-minute break, a cold stimulation test will be applied to the left hand and the subject will be asked to do mental arithmetic calculations simultaneously. Meanwhile, other vibrations will be used. The sympathetic response will be evaluated by heart rate and sympathetic skin response.
Whole body vibration will be applied to the right leg while subjects are sitting with their knee, hip, and ankle joints in a 90-degree position.
The left leg will rest on a vibration-isolated platform. During this position, he will be asked not to voluntarily contract the calf muscle. The vibration will be applied with the PowerPlate® Pro5 WBV (London UK) device. The vibration amplitude will be 2.2 mm. The vibration frequency will be 30, 35, 40, and 45 Hz. Each vibration frequency will be applied for 30 seconds. A 5-second rest period will be applied between 30-second vibrations. Piezo-electric accelerometer (LIS344ALH, full-scale of ± 6 g, linear accelerometer, ECOPACK®, Mansfield, TX, USA) will be fixed on the WBV device platform for reflex latency calculation. For tonic vibration 100, 135, 150, and 180 Hz vibrations will be applied to the Achilles tendon. 30 seconds of vibration will be applied at each frequency. A direct current (DC) motor vibrator will be used to apply this vibration (Bosch™, amplitude 2 mm, motor speed 5000-20000 / min). A piezo-electric accelerometer (LIS344ALH, full-scale of ± 6 g, linear accelerometer, ECOPACK®, Mansfield, TX, USA) will be placed on the skin of the Achilles tendon to calculate the tonic vibration reflex latency. Superficial EMG recordings will be taken from the right soleus muscle with the bipolar technique. A pair of self-adhesive Ag/AgCl (KENDALL® Coviden, Massachusetts, USA) electrodes will be attached to the skin. The electrodes on the soleus will be positioned according to the SENIAM protocol. The ground electrode will have adhered to the right lateral malleolus. Before the electrodes are attached to the skin, if there are hairs on the skin, they will be shaved and the oil layer on the skin will be cleaned with alcohol cotton. In order to increase the moisture of the skin, ECG gel will be applied to the skin area where the electrode will be attached. Superficial EMG recordings will be taken with a PowerLab ® (ADInstrument ADInstruments, Oxford, UK) data recorder with a sample rate of 40 kHz.
EMG recordings will be analyzed offline with LabChart7 Pro® version 7.3.8 (ADInstrument, Oxford, UK). The acceleration measurement data will be recorded with the PowerLab (ADInstrument London) data logger simultaneously with the EMG recording. Acceleration recording will be made with a sample rate of 40 kHz. Simultaneously, heart rate and sympathetic skin response will be captured with a Biopac (Biopac System Inc CA) data recorder at a rate of 20 kHz.
- Conditions
- Vibration; Exposure, Muscle Physiology
- Being tested
- Vibration
- Keywords
- tonic vibration reflex, vibration, whole body vibration, sympathetic activation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VibrationProcedure or surgery
Also called whole body vibration, tendon vibration, sympathetic activation maneuver
whole-body vibration, and tendon vibrations will be applied to the human body
| Study group | Role | What they receive |
|---|---|---|
| Vibration group | Experimental | Vibration (WBV, and tendon vibration) and sympathetic activation maneuvers will be applied to participants Receives: Procedure: Vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole-body vibration (WBV) induced reflex latency
Latency of the soleus reflex response induced by WBV. Its unit is milliseconds
Measured: during intervention, an average of 3 minute
Tendon vibration induced reflex latency
Vibration will be applied to the achilles tendon. The soleus reflex latency induced by the tendon vibration will be measured. Its unit is milliseconds
Measured: during intervention, an average of 3 minute
Secondary outcomes (2)
Heart rate variability
Heart rate variability will be measured to determine sympathetic activity. Low-frequency (LF) and high-frequency (HF) were considered to reflect sympathetic and parasympathetic activity, respectively. The autonomic balance was obtained by the ratio between the sympathetic and parasympathetic areas (LF/HF); wherein ratios >1, <1, and 1 were indicative of sympatheticotonia, vagotonia, and sympathovagal balance, respectively.
Measured: during intervention, an average of 2 hours
Sympathetic skin response
Sympathetic skin response will be measured to determine sympathetic activity.Unit is milliVolt
Measured: during intervention, an average of 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start9 Sep 2022
- Primary completion29 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vibration; ExposureStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ilhan KARACAN, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
- Investigators
- İlhan Karacan, Assoc Prof, Study chair, Istanbul Physical Medicine Rehabilitation Training & Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05478447
- Sponsor's protocol ID
- SSTWBVR
- Status last verified
- Oct 2022
- First submitted
- 26 Jul 2022
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sympathetic Stress on Whole Body Vibration Reflex
- ClinicalTrials.gov ID
- NCT05478447
- Acronym / sponsor ID
- SSTWBVR
- Conditions
- Vibration; Exposure, Muscle Physiology
- Keywords
- tonic vibration reflex, vibration, whole body vibration, sympathetic activation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Istanbul Physical Medicine Rehabilitation Training and Research HospitalOther government
- Study start
- 9 Sep 2022 (actual)
- Primary completion
- 29 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 28 Jul 2022 (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.
Whole body vibration (WBV) is a therapeutic modality in the form of exercise on a vibrating platform with an amplitude of 2-4 mm at a frequency of 25-50 Hz, which is used with increased popularity in sports medicine and rehabilitation due to its beneficial effects on muscle strength, balance, postural control, bone formation, and circulation. Beneficial effects on muscle strength and athletic performance have been reported. Spinal reflexes explain these beneficial neuromuscular effects. However, the neuronal circuit and receptors of the reflex response have not been defined precisely. A group of researchers propose that the reflex system underlying the neuromuscular effects of WBV is the Tonic vibration reflex (TVR), whose receptor is the muscle spindle; other researchers claim that the reflex latency induced by WBV is 4-5 ms longer than the TVR latency, so it is a bone myoregulation reflex whose receptor is osteocytes.
The muscle spindle has sympathetic innervation. It has been reported that in case of increased sympathetic activity, muscle spindle sensitivity may increase and short-latency stretch reflex may be facilitated. The variation of muscle spindle activity with sympathetic activity may provide an opportunity to define the nature of the reflex response during WBV. Muscle spindles are more sensitive to vibrations around 100 Hz. This study has two hypotheses: According to the first hypothesis, WBV activates muscle spindles and the reflex latency induced by WBV is the same as TVR latency, and the latency does not change with increased sympathetic activity. According to the alternative hypothesis, WBV activates osteocytes, and WBV-induced reflex latency is longer than TVR latency. With increased sympathetic activity, the WBV reflex becomes dominant and the WBV-induced reflex latency becomes shorter. The aim of this research is to determine which of these two hypotheses is valid.
Detailed description
22 healthy males between the ages of 20 and 45 will be recruited for this study. All subjects will receive pre-study informed consent. All experimental procedures were designed with the Helsinki declaration in mind and approved by the local ethics committee. In all subjects, whole body vibration(WBV) and isolated tendon vibration will be applied before, after, and during sympathetic activation maneuvers. Reflex responses induced by WBV and isolated tendon vibration will be recorded by surface electromyography (EMG) from the right soleus muscle. Latency calculation will be made using the "Cumulative averaging method".
Mental arithmetic task and cold stress test will be applied as sympathetic activation maneuver. For the mental arithmetic task, the subject is asked to mentally subtract a two-digit number from a four-digit number and respond within five seconds. This arithmetic calculation is repeated for different numbers. This test is continued for two minutes. For the cold stimulation test, subjects are asked to dip their right hand into 2-4 degrees cold water up to the elbow and hold it in the water for two minutes. At this time, either WBV or tendon vibration will be applied. After a ten-minute break, a cold stimulation test will be applied to the left hand and the subject will be asked to do mental arithmetic calculations simultaneously. Meanwhile, other vibrations will be used. The sympathetic response will be evaluated by heart rate and sympathetic skin response.
Whole body vibration will be applied to the right leg while subjects are sitting with their knee, hip, and ankle joints in a 90-degree position.
The left leg will rest on a vibration-isolated platform. During this position, he will be asked not to voluntarily contract the calf muscle. The vibration will be applied with the PowerPlate® Pro5 WBV (London UK) device. The vibration amplitude will be 2.2 mm. The vibration frequency will be 30, 35, 40, and 45 Hz. Each vibration frequency will be applied for 30 seconds. A 5-second rest period will be applied between 30-second vibrations. Piezo-electric accelerometer (LIS344ALH, full-scale of ± 6 g, linear accelerometer, ECOPACK®, Mansfield, TX, USA) will be fixed on the WBV device platform for reflex latency calculation. For tonic vibration 100, 135, 150, and 180 Hz vibrations will be applied to the Achilles tendon. 30 seconds of vibration will be applied at each frequency. A direct current (DC) motor vibrator will be used to apply this vibration (Bosch™, amplitude 2 mm, motor speed 5000-20000 / min). A piezo-electric accelerometer (LIS344ALH, full-scale of ± 6 g, linear accelerometer, ECOPACK®, Mansfield, TX, USA) will be placed on the skin of the Achilles tendon to calculate the tonic vibration reflex latency. Superficial EMG recordings will be taken from the right soleus muscle with the bipolar technique. A pair of self-adhesive Ag/AgCl (KENDALL® Coviden, Massachusetts, USA) electrodes will be attached to the skin. The electrodes on the soleus will be positioned according to the SENIAM protocol. The ground electrode will have adhered to the right lateral malleolus. Before the electrodes are attached to the skin, if there are hairs on the skin, they will be shaved and the oil layer on the skin will be cleaned with alcohol cotton. In order to increase the moisture of the skin, ECG gel will be applied to the skin area where the electrode will be attached. Superficial EMG recordings will be taken with a PowerLab ® (ADInstrument ADInstruments, Oxford, UK) data recorder with a sample rate of 40 kHz.
EMG recordings will be analyzed offline with LabChart7 Pro® version 7.3.8 (ADInstrument, Oxford, UK). The acceleration measurement data will be recorded with the PowerLab (ADInstrument London) data logger simultaneously with the EMG recording. Acceleration recording will be made with a sample rate of 40 kHz. Simultaneously, heart rate and sympathetic skin response will be captured with a Biopac (Biopac System Inc CA) data recorder at a rate of 20 kHz.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vibration group | Experimental | Procedure: VibrationVibration (WBV, and tendon vibration) and sympathetic activation maneuvers will be applied to participants |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Being healthy
- Being a young adult (20-45 years old)
- Volunteer
- Male
Key exclusion criteria (12 listed)
- Scar, dermatitis, etc. in the skin tissue where EMG electrodes will be placed
- Kidney stone history
- Fracture in the lower extremity, history of orthopedic surgery
- Heart disease, Hypertension
- Dizziness
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 |
|---|---|---|
| VibrationAlso: whole body vibration, tendon vibration, sympathetic activation maneuverwhole-body vibration, and tendon vibrations will be applied to the human body | Procedure or surgery | Vibration group |
Primary outcome
Whole-body vibration (WBV) induced reflex latency
Time frame: during intervention, an average of 3 minute
Latency of the soleus reflex response induced by WBV. Its unit is milliseconds
Tendon vibration induced reflex latency
Time frame: during intervention, an average of 3 minute
Vibration will be applied to the achilles tendon. The soleus reflex latency induced by the tendon vibration will be measured. Its unit is milliseconds
2 secondary outcomes
Heart rate variability
Time frame: during intervention, an average of 2 hours
Sympathetic skin response
Time frame: during intervention, an average of 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
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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. This study is not recruiting at the moment.
İlhan Karacan, Assoc Prof study chair
Istanbul Physical Medicine Rehabilitation Training & Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibration in people with Vibration; Exposure and Muscle Physiology, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).
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 4 inclusion and 12 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: finished, as of the sponsor's last update on 13 Oct 2022. 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 Turkey (Türkiye). 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Whole-body vibration (WBV) induced reflex latency (time frame: during intervention, an average of 3 minute). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Oct 2022.