Trial document




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  DRKS00013299

Trial Description

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Title

Controlled strength training in adolescent forensic patients: a pilot study

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

In a prospective, open design, aspects of the feasability and safety of a standardized strength training program in adolescent forensic patients will be investigated. Furthermore psychometric parameter on possible positive effects of the program will be collected to asses effect sizes for the case number calculation of future trials.

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Organizational Data

  •   DRKS00013299
  •   2018/02/07
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  •   yes
  •   Approved
  •   2917-108, Medizinische Ethikkommission der Carl von Ossietzky Universität Oldenburg
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Secondary IDs

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Health Condition or Problem studied

  •   F91.1 -  Unsocialized conduct disorder
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Interventions/Observational Groups

  •   Treatment: standardized strength training for 4 weeks
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Prevention
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

An unwated increase of aggression under strength training, measured as a significant increase of sum scores in the Freiburger Aggressions Fragebogen, State-Trait-Ärgerausdrucks-Inventar and Freiburger Persönlichkeitsinventar.

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Secondary Outcome

An unwanted increase of depressivity, measured as a significant increase of the sum score in Beck's Depression Inventory and Montgomery–Åsberg Depression Rating Scale.
Motivation and suitability of patients to participate
Study adherence and completion of the study according to the study protocol (determination of "completer" and "per protocol set")
Compliance, measured as documented deviation from the study requirements and the completeness of psychometric tests.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Planned
  •   2018/02/09
  •   10
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

-Patients of the Klinik für forensische Jugendpsychiatrie und –psychotherapie, Karl-Jaspers-Klinik
-Written informed consent to particitpate after detailed information
-Minimum age 18 years
-Male gender
-Anticipated stay in the clininc until study completion
-History of aggressive/violent behaviour
-Sufficient intelligence to unterstand and execute psychometric questionaires, tests and training instructions (IQ >= 75)

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Exclusion Criteria

- Medical conditions which may raise concerns regarding the safe execution of the training program
- Serious non-compliance of the patient
- Limited capacity to give informed consent

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Addresses

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    • Carl von Ossietzky Universität Oldenburg
    • Ammerländer Heerstraße 114
    • 26129  Oldenburg
    • Germany
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    • Universitätsklinik für Psychiatrie und PsychotherapieMedizinischer Campus Universität Oldenburg, Karl-Jaspers Klinik
    • Ms.  Dr. med.  Caroline  Lücke 
    • Hermann-Ehlers-Straße 7
    • 26160  Bad Zwischenahn
    • Germany
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    • Klinik für forensische Jugendpsychiatrie und –psychotherapieKarl-Jaspers Klinik
    • Ms.  Bettina  Hackenbroch-Hicke 
    • Hermann-Ehlers-Straße 7
    • 26160  Bad Zwischenahn
    • Germany
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Sources of Monetary or Material Support

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    • Medizinischer Campus Universität Oldenburg, Universitätsklinik für Psychiatrie und Psychotherapie, Karl-Jaspers-Klinik
    • Hermann-Ehlers-Straße 7
    • 26160  Bad Zwischenahn
    • Germany
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Status

  •   Recruiting planned
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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.