Bone MassEBVIMSGNCT01310348
Effect of Bone on Vibration-Induced Muscle Strength Gain
A study testing whole-body vibration (WBV) in people with Bone Mass and Effects of Vibration, run by Bagcilar Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate whether there is a relation between bone mineral density of lower limbs exposed to vibration and the muscle strength gain in the knee extensors and flexors, and a relation serum sclerostin level and the muscle strength gain in the knee extensors and flexors in healthy young… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bone Mass, Effects of Vibration
- What is being tested?
- whole-body vibration (WBV)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Apr 2011to Jun 2011
- 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
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy women,
- Women with ages varying between 20 and 40 years
- Right-handed women
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
- Hypertension ( Diastolic > 85 mmHg, Systolic>135 mmHg)
- Heart Diseases (coronary heart disease, conduction or rhythmic problems, pacemaker etc.)
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- Abdominal disease (Gallstone etc)
- Urinary disease (kidneystone etc)
- Gynecological disease (menstrual irregularities, etc)
- Infectious disease
- Endocrine diseases such as diabetes mellitus or other disease
- Neurologic disorders (central or peripheral)
- Pregnancy or lactation
- Obesity (BMI >30 kg/m2 or body weight > 80 kg )
- Vertigo
- Cognitive dysfunction
- Professional/regular sports activity and heavy worker
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bagcilar Training & Research Hospital
Istanbul
About this study
Official title: Effect of Bone Mineral Density on Vibration-Induced Muscle Strength Gain at The Lower Limbs
The aim of this study is to investigate whether there is a relation between bone mineral density of lower limbs exposed to vibration and the muscle strength gain in the knee extensors and flexors, and a relation serum sclerostin level and the muscle strength gain in the knee extensors and flexors in healthy young adult women.
Forty healthy young adult women are planned to include in this study. The participants meeting the criteria were randomized into two groups: the training group (20 cases) and the Control group (20 cases).
Read more
The whole-body vibration (WBV) training group will be trained on a WBV platform (Power Plate) 5 times a week for 4 weeks period. Participants will be asked to stand upright on WBV platform. Training volume and training intensity will be low at the beginning but progressed slowly according to the overload principle. The training volume will be increased systematically over the 4-week training period. The training intensity will be increased by increasing the amplitude (2-4 mm) and the frequency (40 Hz) of the vibration. The subjects will be asked to report negative side effects or adverse reactions in their training diary. In the Control group, sham stimulus will be performed by WBV platform 5 times a week for a 4 weeks period.
Plasma sclerostin level and, the right and left knee flexor and extensor muscles strength will be measured before and after training period. Isokinetic torque will be measured with the Biodex (Biodex System 3 PRO Multijoint System Biodex Medical Inc. Shirley/NY USA)extremity-testing system. The right and left lower limbs bone mineral density (BMD) and muscle strength will be measured before training period. The BMD will be evaluated by bone densitometer (Norland XR-46 DXA, USA). Sclerostin levels will be measured by human sclerostin ELISA kit.
The rest muscle electrical activity of right and left knee flexor and extensor muscles will be evaluated at pre-vibration, post- vibration and, during vibration. The rest muscle electrical activity will be measured by Powerlab (data acquisition system, ADInstruments, Australia) device.
Read the detailed description
Vibration has a strong osteogenic effect. Vibration-induced bone formation is neuronally regulated. Vibration can also effectively enhance muscle strength and power. Previous studies have shown that vibration increases muscle electromyographic (EMG) activity. Attempts to explain vibration-induced increases in EMG activity were based on the tonic vibration reflex. Tonic vibration reflex activates the muscle spindles, thereby enhancing the excitatory drive reflex of the alpha motoneurons. On the contrary, it was shown that the vibration treatment did not enhance the muscle spindle sensitivity and led to presynaptic inhibition of muscle spindle group Ia afferents. As an alternative to tonic vibration reflex, the recently described bone myoregulation reflex has been suggested to potentially explain the increased muscle strength and electrical activity induced by vibration. Based on the bone myoregulation reflex, bone is sensitive to mechanical stimuli and can send mechanical input signals to central nervous system and so can neuronally regulate the muscle activity.
The cyclic mechanical loading to the bone stimulates the osteocytes. According to bone myoregulation reflex, the more the osteocytes are stimulated by the cyclic mechanical loading, the increase occurring in the muscle strength and activity may be more. The rate of osteocytes stimulated by vibration may be determined with serum sclerostin level. Sclerostin, the protein product of the SOST gene, is an osteocyte-specific cysteine knot-secreted glycoprotein that is a potent inhibitor of bone formation. Sost/sclerostin levels have been reported to be reduced by mechanical stimulation.
- Conditions
- Bone Mass, Effects of Vibration
- Being tested
- whole-body vibration (WBV), WBV (Sham stimulation)
- Keywords
- Bone, Muscle strength, whole-body vibration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whole-body vibration (WBV)Device
Also called Cyclic mechanical loading
The whole-body vibration (WBV) training group will be trained on a WBV platform (Power Plate) 5 times a week for 4 weeks period. Training volume and training intensity will be low at the beginning but progressed slowly according to the overload principle. The training volume will be increased systematically over the 4-week training period. The training intensity will be increased by increasing the amplitude (2-4 mm) and the frequency (40 Hz) of the vibration.
WBV (Sham stimulation)Device
Sham stimulus will be performed by WBV platform 5 times a week for a 4 weeks period.
| Study group | Role | What they receive |
|---|---|---|
| Very low magnitude vibration | Placebo comparator | Very low magnitude vibration Receives: Device: WBV (Sham stimulation) |
| Training | Experimental | The whole-body vibration (WBV) training Receives: Device: whole-body vibration (WBV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vibration-induced muscle strength gain
Effects of bone mineral density on vibration-induced muscle strength gain
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2011 (estimated)
- Study startApr 2011
- Primary completionJun 2011
- Study completionJun 2011
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 Bone MassStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bagcilar Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Karacan, Bagcilar Training and Research Hospital
- Investigators
- ILHAN KARACAN, MD, Study chair, Bagcilar Training & Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01310348
- Sponsor's protocol ID
- BEAH FTR-2
- Acronym
- EBVIMSG
- Status last verified
- Aug 2012
- First submitted
- 7 Mar 2011
- Last updated
- 14 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Cidem 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 25207162
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bone Mineral Density on Vibration-Induced Muscle Strength Gain at The Lower Limbs
- ClinicalTrials.gov ID
- NCT01310348
- Acronym / sponsor ID
- EBVIMSG / BEAH FTR-2
- Conditions
- Bone Mass, Effects of Vibration
- Keywords
- Bone, Muscle strength, whole-body vibration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Bagcilar Training and Research HospitalOther government
- Study start
- Apr 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 8 Mar 2011 (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.
The aim of this study is to investigate whether there is a relation between bone mineral density of lower limbs exposed to vibration and the muscle strength gain in the knee extensors and flexors, and a relation serum sclerostin level and the muscle strength gain in the knee extensors and flexors in healthy young adult women.
Forty healthy young adult women are planned to include in this study. The participants meeting the criteria were randomized into two groups: the training group (20 cases) and the Control group (20 cases).
The whole-body vibration (WBV) training group will be trained on a WBV platform (Power Plate) 5 times a week for 4 weeks period. Participants will be asked to stand upright on WBV platform. Training volume and training intensity will be low at the beginning but progressed slowly according to the overload principle. The training volume will be increased systematically over the 4-week training period. The training intensity will be increased by increasing the amplitude (2-4 mm) and the frequency (40 Hz) of the vibration. The subjects will be asked to report negative side effects or adverse reactions in their training diary. In the Control group, sham stimulus will be performed by WBV platform 5 times a week for a 4 weeks period.
Plasma sclerostin level and, the right and left knee flexor and extensor muscles strength will be measured before and after training period. Isokinetic torque will be measured with the Biodex (Biodex System 3 PRO Multijoint System Biodex Medical Inc. Shirley/NY USA)extremity-testing system. The right and left lower limbs bone mineral density (BMD) and muscle strength will be measured before training period. The BMD will be evaluated by bone densitometer (Norland XR-46 DXA, USA). Sclerostin levels will be measured by human sclerostin ELISA kit.
The rest muscle electrical activity of right and left knee flexor and extensor muscles will be evaluated at pre-vibration, post- vibration and, during vibration. The rest muscle electrical activity will be measured by Powerlab (data acquisition system, ADInstruments, Australia) device.
Detailed description
Vibration has a strong osteogenic effect. Vibration-induced bone formation is neuronally regulated. Vibration can also effectively enhance muscle strength and power. Previous studies have shown that vibration increases muscle electromyographic (EMG) activity. Attempts to explain vibration-induced increases in EMG activity were based on the tonic vibration reflex. Tonic vibration reflex activates the muscle spindles, thereby enhancing the excitatory drive reflex of the alpha motoneurons. On the contrary, it was shown that the vibration treatment did not enhance the muscle spindle sensitivity and led to presynaptic inhibition of muscle spindle group Ia afferents. As an alternative to tonic vibration reflex, the recently described bone myoregulation reflex has been suggested to potentially explain the increased muscle strength and electrical activity induced by vibration. Based on the bone myoregulation reflex, bone is sensitive to mechanical stimuli and can send mechanical input signals to central nervous system and so can neuronally regulate the muscle activity.
The cyclic mechanical loading to the bone stimulates the osteocytes. According to bone myoregulation reflex, the more the osteocytes are stimulated by the cyclic mechanical loading, the increase occurring in the muscle strength and activity may be more. The rate of osteocytes stimulated by vibration may be determined with serum sclerostin level. Sclerostin, the protein product of the SOST gene, is an osteocyte-specific cysteine knot-secreted glycoprotein that is a potent inhibitor of bone formation. Sost/sclerostin levels have been reported to be reduced by mechanical stimulation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Very low magnitude vibration | Placebo comparator | Device: WBV (Sham stimulation)Very low magnitude vibration |
| Training | Experimental | Device: whole-body vibration (WBV)The whole-body vibration (WBV) training |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy women,
- Women with ages varying between 20 and 40 years
- Right-handed women
Key exclusion criteria (17 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
- Neurologic disorders (central or peripheral)
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 |
|---|---|---|
| whole-body vibration (WBV)Also: Cyclic mechanical loadingThe whole-body vibration (WBV) training group will be trained on a WBV platform (Power Plate) 5 times a week for 4 weeks period. Training volume and training intensity will be low at the beginning but progressed slowly according to the overload principle. The training volume will be increased systematically over the 4-week training period. The training intensity will be increased by increasing the amplitude (2-4 mm) and the frequency (40 Hz) of the vibration. | Device | Training |
| WBV (Sham stimulation)Sham stimulus will be performed by WBV platform 5 times a week for a 4 weeks period. | Device | Very low magnitude vibration |
Primary outcome
Vibration-induced muscle strength gain
Time frame: 6 months
Effects of bone mineral density on vibration-induced muscle strength gain
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 14 Aug 2012.
- Derived from this study: 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.
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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.
ILHAN KARACAN, MD study chair
Bagcilar 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 whole-body vibration (WBV) in people with Bone Mass and Effects of Vibration, run by Bagcilar 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 3 inclusion and 17 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 14 Aug 2012. 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. 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?
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 muscle strength gain (time frame: 6 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 NCT01310348, 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 14 Aug 2012.