Trial document




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  DRKS00005712

Trial Description

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Title

Electromyostimulation induced increase of the cramp treshold frequency - dose-response relationship of a novel prevention concept

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Trial Acronym

[---]*

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The targeted application of electrically-induced muscle cramps, applied to adapt the muscle to maximum contractions during minimial muscle length, is a promising approach to reduce the cramp susceptibility. This study aims to investigate to what extend the shift in cramp susceptibility is influenced by a dose-response relationship.

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Brief Summary in Scientific Language

The focus of this study is to investigate the temporal pattern of the cramp threshold frequency (CTF),
the lowest stimulation frequency which elicits a cramp, and blood parameters during two EMS
induced interventions of the human musculus gastrocnemius. It is aimed to establish how the CTF
changes after one intervention over the course of one week and to what extend a following second
intervention further incluences muscular adaptations. For that purpose, ten healthy male sport
students participate in this study. One calf muscle is electrically stimulated (5 sec on, 10 sec off, 400
╬╝sec pulse width, 30 Hz above the individual CTF, 85 % of the maximally tolerated simulation energy),
by means of EMS in a shortened position (plantar flexion), to induce muscle cramps. The calves of five male sport students serve as control.

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Organizational Data

  •   DRKS00005712
  •   2014/02/17
  •   [---]*
  •   yes
  •   Approved
  •   107/13, Ethikkommission der Deutschen Sporthochschule Köln
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   R25.2 -  Cramp and spasm
  •   Healthy Volunteers
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Interventions/Observational Groups

  •   Stimulation of calf muscles in shortened muscle position by use of electromyostimulation (2 times over a period of 2 weeks).
  •   Control group without stimulation
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Measuring the minimal electrical stimulation frequency that induces a muscle cramp (CTF) of the m. gastrocnemius medialis before, and daily after the training intervention for one week

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Secondary Outcome

Collecting venous blood samples for analysing muscle damage marker

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2014/03/03
  •   15
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   18   Years
  •   40   Years
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Additional Inclusion Criteria

Male sport students between 18 and 40 years

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Exclusion Criteria

Any injuries of the musculosceletal system of the lower extremities within the last six months prior
to the study and any cardiiovascular diseases

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Addresses

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    • Institut für Trainingswissenschaft und SportinformatikDeutsche Sporthochschule Köln
    • Am Sportpark Müngersordf 6
    • 50933  Köln
    • Germany
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    • Institut für Trainingswissenschaft und SportinformatikDeutsche Sporthochschule Köln
    • Mr.  Dr. med. Dr. rer. nat.  Michael  Behringer 
    • Am Sportpark Müngersordf 6
    • 50933  Köln
    • Germany
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    • Institut für Trainingswissenschaft und SportinformatikDeutsche Sporthochschule Köln
    • Mr.  Dr. med. Dr. rer. nat  Michael  Behringer 
    • Am Sportpark Müngersordf 6
    • 50933  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Institut für Trainingswissenschaft und Sportinformatik
    • Am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/03/24
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.