Trial document




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  DRKS00012583

Trial Description

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Title

Psychological effects of a whole body electromyostimulation training - a randomized, controlled pilot study with healthy volunteers.

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language





Whole body electromyostimualtion training (EMS) is applied in recreational / top sports, in the rehabilitation and geriatric field, in order to increase the muscular performance. The aim of the study is to investigate whether whole body electromyostimulation training has a positive effect on the condition and the current level of stress.

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Brief Summary in Scientific Language

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00012583
  •   2017/06/22
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  •   yes
  •   Approved
  •   EA2/082/17, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

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Health Condition or Problem studied

  •   Healthy volunteers.
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Interventions/Observational Groups

  •   Training condition A corresponds to a conventional whole body electromyostimulation training. The total duration of the training session is 20 minutes. The washout phase between training conditions A and B resp. B and A is 7 days.
  •   Training condition B training without low-frequency electromyostimulation (but using the same EMS equipment and clothing).
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject
  •   Placebo
  •   Basic research/physiological study
  •   Crossover
  •   N/A
  •   N/A
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Primary Outcome





Subjective well-being (measured by visual analogue scale) before/after intervention.

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Secondary Outcome





Subjective relaxation (measured by visual analogue scale). Current condition (multi-dimensional assessment questionnaire MDBF by Steyer et al., 1997). Current degree of stress (Recovery Stress Questionnaires EBF by Kallus and Kellmann, 2016). Before/after intervention.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2017/06/12
  •   25
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   65   Years
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Additional Inclusion Criteria

Healthy persons, who regularly exercise electromyostimulation training once or twice a week.

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Exclusion Criteria

Exclusion criteria are among others electronic pacemakers and generally electronic implants, acute inflammation, febrile diseases, cancer diseases, untreated arterial hypertension, thrombosis, bleeding or bleeding tendency, apoplexy, neurological disorders such as epilepsy, muscular dystrophies, paresis. Severe hepatic / renal disease.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik für Psychiatrie und PsychotherapieCharité Campus Mitte
    • Mr.  Prof. Dr. med.  Andreas  Ströhle 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Klinik für Psychiatrie und PsychotherapieCharité Campus Mitte
    • Mr.  Prof. Dr. med.  Andreas  Ströhle 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Klinik für Psychiatrie und PsychotherapieCharité Campus Mitte
    • Mr.  Prof. Dr. med.  Andreas  Ströhle 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Psychiatrie und PsychotherapieCharité Campus Mitte
    • Mr.  Prof. Dr. med.  Andreas  Ströhle 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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