NCT01103232

Brief 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 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2008

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 14, 2010

Completed
2 years until next milestone

Results Posted

Study results publicly available

March 26, 2012

Completed
Last Updated

June 25, 2012

Status Verified

June 1, 2012

Enrollment Period

1.2 years

First QC Date

April 12, 2010

Results QC Date

August 13, 2011

Last Update Submit

June 20, 2012

Conditions

Keywords

Cross educationMuscle training

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 weeks (The change calculated as 6 months minus baseline)

Study Arms (2)

Electrical Muscle Stimulation

EXPERIMENTAL

Electrical muscle stimulation of the right wrist flexor muscles was applied

Procedure: Experimental group

Control

SHAM COMPARATOR

Transcutaneous electrical nerve stimulation was applied

Procedure: Control group

Interventions

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.)

Also known as: Electrical Muscle Stimulation
Electrical Muscle Stimulation
Control groupPROCEDURE

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).

Also known as: Transcutaneous electrical muscle stimulation
Control

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • young-adult healthy volunteer
  • male
  • right hand dominant

You may not qualify if:

  • 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
  • joint disease
  • cardiac pacemaker
  • noncooperative
  • professional sportsman
  • regular sportive activity such as tennis, volleyball
  • heavy worker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Limitations and Caveats

This study has small sample size.

Results Point of Contact

Title
ILHAN KARACAN
Organization
Vakif Gureba Training and Research Hospital

Study Officials

  • ILHAN KARACAN, MD

    Vakif Gureba Training & Research Hospital

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Physical Med & Rehab Clinic

Study Record Dates

First Submitted

April 12, 2010

First Posted

April 14, 2010

Study Start

January 1, 2008

Primary Completion

April 1, 2009

Study Completion

June 1, 2009

Last Updated

June 25, 2012

Results First Posted

March 26, 2012

Record last verified: 2012-06