Muscle PhysiologyWBVIMR-SLNCT02468011
Whole Body Vibration Induced Muscle Activity and Effect of the Changes in Length of Soleus Muscle and Angle of Ankle
A study testing vibration in people with Muscle Physiology, run by Bagcilar Training and Research Hospital.
Trial summary
Previous studies reported that myoelectrical activity increased during whole body vibration (WBV). The investigators hypothesized that the change in soleus muscle length does not affect the whole body vibration induced soleus reflex muscle activity but the change in ankle angle affects the whole body induced soleus… Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Muscle Physiology
- What is being tested?
- vibration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Jul 2015
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy men
- Men with ages varying between 20 and 40 years
- Right-handed men
Who cannot join
- Bone, muscle/tendon, joint, vascular, dermatologic diseases in lower extremities and spine
- Medication that could affect the musculoskeletal system
- Postural abnormalities (scoliosis, kyphosis, etc)
- Systemic diseases (Cardiopulmonary diseases, diabetes mellitus etc)
- Obesity (BMI>30 kg/m2)
- Vertigo / dizziness
About this study
Official title: Whole Body Vibration Induced Muscle Activity in Different Position of Lower Extremity: Effect of the Changes in Length of Soleus Muscle and Angle of Ankle
Previous studies reported that myoelectrical activity increased during whole body vibration (WBV). The investigators hypothesized that the change in soleus muscle length does not affect the whole body vibration induced soleus reflex muscle activity but the change in ankle angle affects the whole body induced soleus reflex muscle activity. The purpose of this study is to test this hypothesis.
Read the detailed description
Eighteen healthy young adult men are planned to include in this study. Surface electrodes will be placed on the right soleus muscle's belly. The electrodes (10-mm in diameter, inter-electrode distance of 20 mm) were arranged in the direction of the muscle fibers. The skin overlying the muscle was shaved, light abrasion was applied, and the skin was cleaned using 70% alcohol.
A piezo-electric accelerometer (LIS344ALH full-scale of ±6 g linear accelerometer, ECOPACK) will be placed on the achilles tendon and a force sensor (FC2331-0000-2000L Compression Load Sensor, France) will be placed under the right heel. All data will be recorded by PowerLab (data acquisition system, ADInstruments, Australia) device. The data were processed offline with a computer. All surface electromyography (SEMG) analyses were conducted using a software (LABCHART7 ver. 7.3.3; POWERLAB System, ADInstruments). All SEMG recordings were 80-500 Hz band-pass filtered. Root-mean-square values (RMS) were calculated from the filtered SEMG signal.
WBV (PowerPlate Pro5) with high amplitude at 35 Hz will be applied. Participants were barefooted, and no sponge or foam was placed between the vibration platform and their feet. Participants will stand in different position with their knees locked during WBV. Their hips and knees were in a neutral position. Positions: Position-1: Upright standing on zero sloping vibration platform Position-2: Standing with 10 degrees ankle dorsiflexion on zero sloping vibration platform Position-3: Standing with 20 degrees ankle plantarflexion on zero sloping vibration platform Position-4: Upright standing on twenty degrees forward inclined vibration platform (angle angle will be 20 degrees ankle plantarflexion) Position-5: Leaning forward while standing on twenty degrees forward inclined vibration platform (angle angle will be neutral) Position-6: Upright standing on 10 degrees backward inclined vibration platform (angle angle will be 20 degrees ankle dorsiflexion) Position-7: Leaning backward while standing on 10 degrees backward inclined vibration platform (angle angle will be neutral) Sequence of the position will be random. Maximal voluntary contraction (MVC) was determined for each subject at the beginning of each position using magnitude of force between heel and vibration platform the when the subject attempted to activate the soleus muscle maximally. Then vibration exposure will be 30 seconds.
The participants were instructed to relax their muscles throughout the recordings during WBV and were trained using electromyographic feedback to this end. WBV may impair the sense of balance and muscles may be activated to restore balance. To overcome this problem, the participants were familiarized with WBV with a 15 s trial session on the WBV device and they were asked to use the handles of the device to secure their balance.
- Conditions
- Muscle Physiology
- Being tested
- vibration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vibrationOther
vibration will be applied at 35 Hz
| Study group | Role | What they receive |
|---|---|---|
| Vibration | Experimental | Whole body vibration with 35 Hz Receives: Other: vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vibration induced reflex muscle activity level
Measured: Four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Muscle PhysiologyStudies 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bagcilar Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ilhan Karacan, Clinical Associated Professor, Bagcilar Training and Research Hospital
- Investigators
- 90 212 4404000 90 212 4404000, MD, Study chair, Bagcilar Training & Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02468011
- Sponsor's protocol ID
- BEAH FTR-10
- Acronym
- WBVIMR-SL
- Status last verified
- Jul 2015
- First submitted
- 8 Jun 2015
- Last updated
- 28 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Pollock RD, Woledge RC, Martin FC, Newham DJ. Effects of whole body vibration on motor unit recruitment and threshold. J Appl Physiol (1985). 2012 Feb;112(3):388-95. doi: 10.1152/japplphysiol.01223.2010. Epub 2011 Nov 17.
PubMed 22096119Ritzmann R, Kramer A, Gollhofer A, Taube W. The effect of whole body vibration on the H-reflex, the stretch reflex, and the short-latency response during hopping. Scand J Med Sci Sports. 2013 Jun;23(3):331-9. doi: 10.1111/j.1600-0838.2011.01388.x.
PubMed 23802287Cidem M, Karacan I, Diracoglu D, Yildiz A, Kucuk SH, Uludag M, Gun K, Ozkaya M, Karamehmetoglu SS. A Randomized Trial on the Effect of Bone Tissue on Vibration-induced Muscle Strength Gain and Vibration-induced Reflex Muscle Activity. Balkan Med J. 2014 Mar;31(1):11-22. doi: 10.5152/balkanmedj.2013.9482. Epub 2014 Mar 1.
PubMed 25207162Sebik O, Karacan I, Cidem M, Turker KS. Rectification of SEMG as a tool to demonstrate synchronous motor unit activity during vibration. J Electromyogr Kinesiol. 2013 Apr;23(2):275-84. doi: 10.1016/j.jelekin.2012.09.009. Epub 2012 Oct 23.
PubMed 23098913
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole Body Vibration Induced Muscle Activity in Different Position of Lower Extremity: Effect of the Changes in Length of Soleus Muscle and Angle of Ankle
- ClinicalTrials.gov ID
- NCT02468011
- Acronym / sponsor ID
- WBVIMR-SL / BEAH FTR-10
- Conditions
- Muscle Physiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Bagcilar Training and Research HospitalOther government
- Study start
- Jun 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 10 Jun 2015 (estimated)
- 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.
Previous studies reported that myoelectrical activity increased during whole body vibration (WBV). The investigators hypothesized that the change in soleus muscle length does not affect the whole body vibration induced soleus reflex muscle activity but the change in ankle angle affects the whole body induced soleus reflex muscle activity. The purpose of this study is to test this hypothesis.
Detailed description
Eighteen healthy young adult men are planned to include in this study. Surface electrodes will be placed on the right soleus muscle's belly. The electrodes (10-mm in diameter, inter-electrode distance of 20 mm) were arranged in the direction of the muscle fibers. The skin overlying the muscle was shaved, light abrasion was applied, and the skin was cleaned using 70% alcohol.
A piezo-electric accelerometer (LIS344ALH full-scale of ±6 g linear accelerometer, ECOPACK) will be placed on the achilles tendon and a force sensor (FC2331-0000-2000L Compression Load Sensor, France) will be placed under the right heel. All data will be recorded by PowerLab (data acquisition system, ADInstruments, Australia) device. The data were processed offline with a computer. All surface electromyography (SEMG) analyses were conducted using a software (LABCHART7 ver. 7.3.3; POWERLAB System, ADInstruments). All SEMG recordings were 80-500 Hz band-pass filtered. Root-mean-square values (RMS) were calculated from the filtered SEMG signal.
WBV (PowerPlate Pro5) with high amplitude at 35 Hz will be applied. Participants were barefooted, and no sponge or foam was placed between the vibration platform and their feet. Participants will stand in different position with their knees locked during WBV. Their hips and knees were in a neutral position. Positions: Position-1: Upright standing on zero sloping vibration platform Position-2: Standing with 10 degrees ankle dorsiflexion on zero sloping vibration platform Position-3: Standing with 20 degrees ankle plantarflexion on zero sloping vibration platform Position-4: Upright standing on twenty degrees forward inclined vibration platform (angle angle will be 20 degrees ankle plantarflexion) Position-5: Leaning forward while standing on twenty degrees forward inclined vibration platform (angle angle will be neutral) Position-6: Upright standing on 10 degrees backward inclined vibration platform (angle angle will be 20 degrees ankle dorsiflexion) Position-7: Leaning backward while standing on 10 degrees backward inclined vibration platform (angle angle will be neutral) Sequence of the position will be random. Maximal voluntary contraction (MVC) was determined for each subject at the beginning of each position using magnitude of force between heel and vibration platform the when the subject attempted to activate the soleus muscle maximally. Then vibration exposure will be 30 seconds.
The participants were instructed to relax their muscles throughout the recordings during WBV and were trained using electromyographic feedback to this end. WBV may impair the sense of balance and muscles may be activated to restore balance. To overcome this problem, the participants were familiarized with WBV with a 15 s trial session on the WBV device and they were asked to use the handles of the device to secure their balance.
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 | Experimental | Other: vibrationWhole body vibration with 35 Hz |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy men
- Men with ages varying between 20 and 40 years
- Right-handed men
Key exclusion criteria (6 listed)
- Bone, muscle/tendon, joint, vascular, dermatologic diseases in lower extremities and spine
- Medication that could affect the musculoskeletal system
- Postural abnormalities (scoliosis, kyphosis, etc)
- Systemic diseases (Cardiopulmonary diseases, diabetes mellitus etc)
- Obesity (BMI>30 kg/m2)
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 |
|---|---|---|
| vibrationvibration will be applied at 35 Hz | Other | Vibration |
Primary outcome
Vibration induced reflex muscle activity level
Time frame: Four months
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 28 Jul 2015.
- Background: PubMed 22096119Pollock RD, Woledge RC, Martin FC, Newham DJ. Effects of whole body vibration on motor unit recruitment and threshold. J Appl Physiol (1985). 2012 Feb;112(3):388-95. doi: 10.1152/japplphysiol.01223.2010. Epub 2011 Nov 17.
- Background: PubMed 23802287Ritzmann R, Kramer A, Gollhofer A, Taube W. The effect of whole body vibration on the H-reflex, the stretch reflex, and the short-latency response during hopping. Scand J Med Sci Sports. 2013 Jun;23(3):331-9. doi: 10.1111/j.1600-0838.2011.01388.x.
- Background: PubMed 25207162Cidem M, Karacan I, Diracoglu D, Yildiz A, Kucuk SH, Uludag M, Gun K, Ozkaya M, Karamehmetoglu SS. A Randomized Trial on the Effect of Bone Tissue on Vibration-induced Muscle Strength Gain and Vibration-induced Reflex Muscle Activity. Balkan Med J. 2014 Mar;31(1):11-22. doi: 10.5152/balkanmedj.2013.9482. Epub 2014 Mar 1.
- Background: PubMed 23098913Sebik O, Karacan I, Cidem M, Turker KS. Rectification of SEMG as a tool to demonstrate synchronous motor unit activity during vibration. J Electromyogr Kinesiol. 2013 Apr;23(2):275-84. doi: 10.1016/j.jelekin.2012.09.009. Epub 2012 Oct 23.
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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.
90 212 4404000 90 212 4404000, MD study chair
Bagcilar Training & Research Hospital
Questions about this trial
What is this clinical trial studying?
A study testing vibration in people with Muscle Physiology, run by Bagcilar Training and Research Hospital.
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 3 inclusion and 6 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 28 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Vibration induced reflex muscle activity level (time frame: Four months). 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 NCT02468011, which also lists 4 linked publications.
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 28 Jul 2015.