Muscle Strength Quantitative Trait Locus 1NCT01103232
Cross-Education Of Contralateral Antagonists
A study testing Experimental group in people with Muscle Strength Quantitative Trait Locus 1, run by Vakif Gureba Training and Research Hospital.
Trial summary
Previous studies well documented the impact of unilateral training of limb muscle on the untrained contralateral homologous muscle. The aim of this study is to evaluate whether the electrical muscle stimulation on the dominant wrist flexors for 6 weeks cause an increase in the muscle strength of the contralateral… 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
- Muscle Strength Quantitative Trait Locus 1
- What is being tested?
- Experimental group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Jun 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- young-adult healthy volunteer
- male
- right hand dominant
Who cannot join
- a chronic disease such as metabolic/endocrine bone disease (osteoporosis, osteomalacia, paget's disease etc)
- myopathy
- tendinopathy
- neurologic disorders (hypoesthesia/anesthesia, epilepsy, paralysis)
- dermatologic disease
- peripheral vascular disease
Show all 12Show fewer
- joint disease
- cardiac pacemaker
- noncooperative
- professional sportsman
- regular sportive activity such as tennis, volleyball
- heavy worker
About this study
Official title: Cross-Education Of Muscular Strength: Is Cross-Training Effects Confined To Untrained Contralateral Homologous Muscle
Previous studies well documented the impact of unilateral training of limb muscle on the untrained contralateral homologous muscle. The aim of this study is to evaluate whether the electrical muscle stimulation on the dominant wrist flexors for 6 weeks cause an increase in the muscle strength of the contralateral wrist extensors in healthy adult men.
Ethical approval was obtained from Institutional Review Board. All participants were volunteers and provided written informed consent. Among young adult males working in our hospital, 30 subjects who voluntarily accepted to participate in this study were assessed for eligibility. Twenty three young-adult healthy males were included in this double-blind prospective study. These volunteers were randomized into two groups. In Electrical Muscle Stimulation (EMS) group, electrical muscle stimulation of the right wrist flexor muscles was applied; in Controls, transcutaneous electrical nerve stimulation was applied. Electrodes were placed over the flexor aspect of the right forearm in both groups. Electrical stimulation was applied for thirty sessions (one session a day, five days a week for six weeks) in both groups by the same researcher. Compex2 (Medicompex SA, Switzerland) was used for electrical stimulation. Isokinetic torque was measured in the right and left wrist flexors and extensors before and after trial. Isokinetic torque was measured in the right (trained) and left (untrained) forearm with the Cybex (Humac 2004/Norm) extremity-testing system.
Read the detailed description
It has been reported that strength training of unilateral limb causes an increase in voluntary strength not only in the trained limb, but also in the contralateral untrained limb. This phenomenon is known as "cross-education, cross-training or contralateral strength training effect" . Cross-education of muscle strength can occur in both upper and lower limb muscles.It is not gender and age specific and can occur with training accomplished by voluntary effort, electrical stimulation of muscles or mental practice of unilateral contractions. Electrostimulation is one of the most efficient methods to induce cross-education.
Although it is clear that unilateral training has a contralateral effect, the mechanisms behind this effect remain unclear. Because of the specific nature of cross education, modification in neural function is the more likely mechanism underlying this effect. The potential neural mechanisms can be broadly categorized as either ''central" or ''peripheral (spinal)" adaptations. Central neural mechanisms involved in the excitation of the relevant part of the cortex during voluntary contraction of the trained limb are thought to produce contralateral facilitation. The cross-extension reflex is the primary spinal neural mechanism for cross-education.
In the studies performed up today, the contralateral effects of unilateral training were evaluated in the contralateral homologous muscles. However it's not reported whether a change in the muscle strength have been observed in the antagonists of the contralateral homologous muscles. In a study, after one session of unilateral surface electrical stimulation of the rectus femoris, an increase in the isometric force and EMG activity of the contralateral rectus femoris, but a decrease in the EMG activity of the contralateral biceps femoris was reported in adult men. It's proposed that, the EMG activity decrease in the biceps femoris may be explained by cross-extension reflex. The effect of long-time exercise or electrical muscle stimulation on the antagonists of the contralateral homologous muscles is not clear.
The aim of this study is to evaluate whether the electrical muscle stimulation on the dominant wrist flexors for 6 weeks cause an increase in the muscle strength of the contralateral wrist extensors in healthy adult men.
- Being tested
- Experimental group, Control group
- Keywords
- Cross education, Muscle training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental groupProcedure or surgery
Also called Electrical Muscle Stimulation
Electrical muscle stimulation (EMS) of the right wrist flexor muscles was applied. EMS was applied for 20 minutes. Maximum current intensity tolerated was used so as to stimulate the highest possible number of motor unit. The stimulation intensity increased every five minutes during a session. Electrical stimulation was applied for thirty sessions (one session a day, five days a week for six weeks.)
Control groupProcedure or surgery
Also called Transcutaneous electrical muscle stimulation
Conventional mode of transcutaneous electrical nerve stimulation (TENS) was applied for the control subjects. TENS was applied for 20 minutes. The stimulus intensity was adjusted as the lowest current at which the subject felt only a slight tickling of the impulses. A visible, and palpable muscle contraction was not provided during TENS stimulation. The stimulus intensity was not changed during the first session. Subsequently, TENS was applied at same intensity in all sessions. TENS was applied for thirty sessions (one session a day, five days a week for six weeks).
| Study group | Role | What they receive |
|---|---|---|
| Electrical Muscle Stimulation | Experimental | Electrical muscle stimulation of the right wrist flexor muscles was applied Receives: Procedure: Experimental group |
| Control | Sham comparator | Transcutaneous electrical nerve stimulation was applied Receives: Procedure: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Muscle Strength in the Contralateral Untrained Wrist Muscles
Isokinetic torque was measured in the contralateral untrained wrist muscles with the Cybex (Humac 2004/Norm) extremity-testing system before and after experiment.
Measured: 6 weeks (The change calculated as 6 months minus baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2010 (estimated)
- Study startJan 2008
- Primary completionApr 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscle Strength Quantitative Trait Locus 1Studies 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
- 30 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
- NCT01103232
- Sponsor's protocol ID
- VGEAH FTR
- Status last verified
- Jun 2012
- First submitted
- 12 Apr 2010
- Last updated
- 25 Jun 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Sariyildiz M, Karacan I, Rezvani A, Ergin O, Cidem M. Cross-education of muscle strength: cross-training effects are not confined to untrained contralateral homologous muscle. Scand J Med Sci Sports. 2011 Dec;21(6):e359-64. doi: 10.1111/j.1600-0838.2011.01311.x. Epub 2011 Apr 18.
PubMed 21496110
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-Education Of Muscular Strength: Is Cross-Training Effects Confined To Untrained Contralateral Homologous Muscle
- ClinicalTrials.gov ID
- NCT01103232
- Acronym / sponsor ID
- VGEAH FTR
- Keywords
- Cross education, Muscle training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Vakif Gureba Training and Research HospitalUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 14 Apr 2010 (estimated)
- Results
- Posted 26 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Previous studies well documented the impact of unilateral training of limb muscle on the untrained contralateral homologous muscle. The aim of this study is to evaluate whether the electrical muscle stimulation on the dominant wrist flexors for 6 weeks cause an increase in the muscle strength of the contralateral wrist extensors in healthy adult men.
Ethical approval was obtained from Institutional Review Board. All participants were volunteers and provided written informed consent. Among young adult males working in our hospital, 30 subjects who voluntarily accepted to participate in this study were assessed for eligibility. Twenty three young-adult healthy males were included in this double-blind prospective study. These volunteers were randomized into two groups. In Electrical Muscle Stimulation (EMS) group, electrical muscle stimulation of the right wrist flexor muscles was applied; in Controls, transcutaneous electrical nerve stimulation was applied. Electrodes were placed over the flexor aspect of the right forearm in both groups. Electrical stimulation was applied for thirty sessions (one session a day, five days a week for six weeks) in both groups by the same researcher. Compex2 (Medicompex SA, Switzerland) was used for electrical stimulation. Isokinetic torque was measured in the right and left wrist flexors and extensors before and after trial. Isokinetic torque was measured in the right (trained) and left (untrained) forearm with the Cybex (Humac 2004/Norm) extremity-testing system.
Detailed description
It has been reported that strength training of unilateral limb causes an increase in voluntary strength not only in the trained limb, but also in the contralateral untrained limb. This phenomenon is known as "cross-education, cross-training or contralateral strength training effect" . Cross-education of muscle strength can occur in both upper and lower limb muscles.It is not gender and age specific and can occur with training accomplished by voluntary effort, electrical stimulation of muscles or mental practice of unilateral contractions. Electrostimulation is one of the most efficient methods to induce cross-education.
Although it is clear that unilateral training has a contralateral effect, the mechanisms behind this effect remain unclear. Because of the specific nature of cross education, modification in neural function is the more likely mechanism underlying this effect. The potential neural mechanisms can be broadly categorized as either ''central" or ''peripheral (spinal)" adaptations. Central neural mechanisms involved in the excitation of the relevant part of the cortex during voluntary contraction of the trained limb are thought to produce contralateral facilitation. The cross-extension reflex is the primary spinal neural mechanism for cross-education.
In the studies performed up today, the contralateral effects of unilateral training were evaluated in the contralateral homologous muscles. However it's not reported whether a change in the muscle strength have been observed in the antagonists of the contralateral homologous muscles. In a study, after one session of unilateral surface electrical stimulation of the rectus femoris, an increase in the isometric force and EMG activity of the contralateral rectus femoris, but a decrease in the EMG activity of the contralateral biceps femoris was reported in adult men. It's proposed that, the EMG activity decrease in the biceps femoris may be explained by cross-extension reflex. The effect of long-time exercise or electrical muscle stimulation on the antagonists of the contralateral homologous muscles is not clear.
The aim of this study is to evaluate whether the electrical muscle stimulation on the dominant wrist flexors for 6 weeks cause an increase in the muscle strength of the contralateral wrist extensors in healthy adult men.
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 |
|---|---|---|
| Electrical Muscle Stimulation | Experimental | Procedure: Experimental groupElectrical muscle stimulation of the right wrist flexor muscles was applied |
| Control | Sham comparator | Procedure: Control groupTranscutaneous electrical nerve stimulation was applied |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- young-adult healthy volunteer
- male
- right hand dominant
Key exclusion criteria (12 listed)
- a chronic disease such as metabolic/endocrine bone disease (osteoporosis, osteomalacia, paget's disease etc)
- myopathy
- tendinopathy
- neurologic disorders (hypoesthesia/anesthesia, epilepsy, paralysis)
- dermatologic disease
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 |
|---|---|---|
| Experimental groupAlso: Electrical Muscle StimulationElectrical muscle stimulation (EMS) of the right wrist flexor muscles was applied. EMS was applied for 20 minutes. Maximum current intensity tolerated was used so as to stimulate the highest possible number of motor unit. The stimulation intensity increased every five minutes during a session. Electrical stimulation was applied for thirty sessions (one session a day, five days a week for six weeks.) | Procedure or surgery | Electrical Muscle Stimulation |
| Control groupAlso: Transcutaneous electrical muscle stimulationConventional mode of transcutaneous electrical nerve stimulation (TENS) was applied for the control subjects. TENS was applied for 20 minutes. The stimulus intensity was adjusted as the lowest current at which the subject felt only a slight tickling of the impulses. A visible, and palpable muscle contraction was not provided during TENS stimulation. The stimulus intensity was not changed during the first session. Subsequently, TENS was applied at same intensity in all sessions. TENS was applied for thirty sessions (one session a day, five days a week for six weeks). | Procedure or surgery | Control |
Primary outcome
Changes in Muscle Strength in the Contralateral Untrained Wrist Muscles
Time frame: 6 weeks (The change calculated as 6 months minus baseline)
Isokinetic torque was measured in the contralateral untrained wrist muscles with the Cybex (Humac 2004/Norm) extremity-testing system before and after experiment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21496110Sariyildiz M, Karacan I, Rezvani A, Ergin O, Cidem M. Cross-education of muscle strength: cross-training effects are not confined to untrained contralateral homologous muscle. Scand J Med Sci Sports. 2011 Dec;21(6):e359-64. doi: 10.1111/j.1600-0838.2011.01311.x. Epub 2011 Apr 18.
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
Questions about this trial
What is this clinical trial studying?
A study testing Experimental group in people with Muscle Strength Quantitative Trait Locus 1, run by Vakif Gureba 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 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 25 Jun 2012. 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. 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?
Yes. Results are posted in the registry (first posted 26 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Muscle Strength in the Contralateral Untrained Wrist Muscles (time frame: 6 weeks (The change calculated as 6 months minus baseline)). 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 NCT01103232, 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 25 Jun 2012.