OsteoporosisBMRR3NCT01097122
Effects Of Unilateral Vibration On Contralateral Forearm Muscle Activity
A study testing Forearm vibration in people with Osteoporosis and Excitability, run by Vakif Gureba Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study hypothesize that radius subjecting to mechanical loading may affect excitability of alpha motor neuron innervating muscle, based on its bone mineral density or bone mineral content. A total of 80 voluntaries are planned to include in this study. Vibration will be applied the right forearm. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Excitability
- What is being tested?
- Forearm vibration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2010to Jul 2010
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects
- Right handed
- Young adult women and men
Who cannot join
- secondary osteoporosis
- neuropathy (central or peripheral)
- myopathy
- systemic diseases (arthritis, endocrine-metabolic diseases, bone diseases)
- professional sportswoman/sportsman
- subjects doing regular sports activities
- tendinopathy
- amputee, endoprosthesis, metal implants
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Vakif Gureba Training & Research Hospital
Istanbul, 34000
About this study
Official title: Effects Of Unilateral Forearm Vibration On Electrical Activity Of Untrained Contralateral Forearm Muscle
This study hypothesize that radius subjecting to mechanical loading may affect excitability of alpha motor neuron innervating muscle, based on its bone mineral density or bone mineral content.
A total of 80 voluntaries are planned to include in this study. Vibration will be applied the right forearm. Muscle electrical activity will be measured on ipsilateral and contralateral flexor carpi radialis (FCR) muscle at rest as EMGrms by surface electromyography (EMG). The rest-EMGrms will be measured at before and during vibration. An increase in muscle electrical activity at rest indicates an increase in motor neuron pool activation. The right distal radius bone mineral content (BMC) and density will be measured by dual energy X-ray absorptiometry (DXA).
Read more
The right radius bone mineral density (BMD) and BMC will be evaluated by bone densitometer (GE-LUNAR DPX PRO).
Motor unit potentials will be measured by electromyography at left flexor carpi radialis. Neurotrac ETS device will be used.
Read the detailed description
A functional cooperation exists between bones and skeletal muscles. Bones work together with muscles as a simple mechanical lever system to produce body movement. One of the important functions of bones is to exert resistance against gravity in order to carry the body. In order to carry out their mechanical functions, bones need to have considerable resistance to deformation under load. It is well-known that muscle activity (i.e., exercises) improves the resistance of bone to mechanical loading, and that it is also important for treating and preventing osteoporosis. Resistance and impact training have been shown to induce bone formation and/or prevent bone resorption. Skeletal muscles have positive effects on bone structure and function. Can bones have an effect on muscle activity? There is only one study about the effect of bones on muscles. In this study, it was shown that bones may affect muscle strength gain in healthy young adult males.
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. But, it has not been reported whether bone has an effect on the increase in muscle EMG activity caused by vibration or not. The aim of this study was to determine whether radius bone exposed to cyclic mechanical loading affects muscle electrical activity of contralateral untrained m. flexor carpi radialis in healthy adult volunteers.
- Conditions
- Osteoporosis, Excitability
- Being tested
- Forearm vibration
- Keywords
- bone, motor neuron excitability, forearm vibration, mechanical loading, muscle electrical activity
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forearm vibrationProcedure or surgery
Also called Cyclic mechanical loading
Mechanical loading with forearm vibration will be applied right radius in all groups
| Study group | Role | What they receive |
|---|---|---|
| Healthy young adult subjects | Experimental | Forearm vibration will be applied in healthy young adult subjects Receives: Procedure: Forearm vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in rest muscle electrical activity in the contralateral untrained flexor carpi radialis during the right forearm vibration
Rest muscle electrical activity changes will be examined in the contralateral untrained flexor carpi radialis during the right forearm vibration
Measured: 2 or 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2010 (estimated)
- Study startMar 2010
- Primary completionJun 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vakif Gureba Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ILHAN KARACAN, Vakif Gureba Training and Research Hospital
- Investigators
- ILHAN KARACAN, MD, Study chair, Vakif Gureba Training & Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01097122
- Sponsor's protocol ID
- VGEAH FTR-3
- Acronym
- BMRR3
- Status last verified
- Feb 2012
- First submitted
- 27 Mar 2010
- Last updated
- 27 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Unilateral Forearm Vibration On Electrical Activity Of Untrained Contralateral Forearm Muscle
- ClinicalTrials.gov ID
- NCT01097122
- Acronym / sponsor ID
- BMRR3 / VGEAH FTR-3
- Conditions
- Osteoporosis, Excitability
- Keywords
- bone, motor neuron excitability, forearm vibration, mechanical loading, muscle electrical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Vakif Gureba Training and Research HospitalUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 1 Apr 2010 (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.
This study hypothesize that radius subjecting to mechanical loading may affect excitability of alpha motor neuron innervating muscle, based on its bone mineral density or bone mineral content.
A total of 80 voluntaries are planned to include in this study. Vibration will be applied the right forearm. Muscle electrical activity will be measured on ipsilateral and contralateral flexor carpi radialis (FCR) muscle at rest as EMGrms by surface electromyography (EMG). The rest-EMGrms will be measured at before and during vibration. An increase in muscle electrical activity at rest indicates an increase in motor neuron pool activation. The right distal radius bone mineral content (BMC) and density will be measured by dual energy X-ray absorptiometry (DXA).
The right radius bone mineral density (BMD) and BMC will be evaluated by bone densitometer (GE-LUNAR DPX PRO).
Motor unit potentials will be measured by electromyography at left flexor carpi radialis. Neurotrac ETS device will be used.
Detailed description
A functional cooperation exists between bones and skeletal muscles. Bones work together with muscles as a simple mechanical lever system to produce body movement. One of the important functions of bones is to exert resistance against gravity in order to carry the body. In order to carry out their mechanical functions, bones need to have considerable resistance to deformation under load. It is well-known that muscle activity (i.e., exercises) improves the resistance of bone to mechanical loading, and that it is also important for treating and preventing osteoporosis. Resistance and impact training have been shown to induce bone formation and/or prevent bone resorption. Skeletal muscles have positive effects on bone structure and function. Can bones have an effect on muscle activity? There is only one study about the effect of bones on muscles. In this study, it was shown that bones may affect muscle strength gain in healthy young adult males.
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. But, it has not been reported whether bone has an effect on the increase in muscle EMG activity caused by vibration or not. The aim of this study was to determine whether radius bone exposed to cyclic mechanical loading affects muscle electrical activity of contralateral untrained m. flexor carpi radialis in healthy adult volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy young adult subjects | Experimental | Procedure: Forearm vibrationForearm vibration will be applied in healthy young adult subjects |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy subjects
- Right handed
- Young adult women and men
Key exclusion criteria (8 listed)
- secondary osteoporosis
- neuropathy (central or peripheral)
- myopathy
- systemic diseases (arthritis, endocrine-metabolic diseases, bone diseases)
- professional sportswoman/sportsman
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 |
|---|---|---|
| Forearm vibrationAlso: Cyclic mechanical loadingMechanical loading with forearm vibration will be applied right radius in all groups | Procedure or surgery | Healthy young adult subjects |
Primary outcome
Changes in rest muscle electrical activity in the contralateral untrained flexor carpi radialis during the right forearm vibration
Time frame: 2 or 3 weeks
Rest muscle electrical activity changes will be examined in the contralateral untrained flexor carpi radialis during the right forearm vibration
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 27 Feb 2012.
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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
Vakif Gureba 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 Forearm vibration in people with Osteoporosis and Excitability, run by Vakif Gureba 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 8 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 27 Feb 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. 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?
Changes in rest muscle electrical activity in the contralateral untrained flexor carpi radialis during the right forearm vibration (time frame: 2 or 3 weeks). 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 27 Feb 2012.