Trial document




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  DRKS00011772

Trial Description

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Title

Randomized controlled effects of a whole body vibration training on clinical symptoms and neurobiology in adolescent inpatients with major depressive episode

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Trial Acronym

Balancing Vibrations

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URL of the Trial

http://neurologie-psychiatrie.uk-koeln.de/kinder-und-jugendpsychiatrie/klinik/stationaere-versorgung/jugendstation-1-2

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Brief Summary in Lay Language

The positive effects of exercise in adult depression has already be found in previous studies. In our pilot study “Mood Vibes” we could demonstrate that high-intensity training with vibration devices (“whole body vibrations – WBV) has the same antidepressant effects as endurance sport in depressive adolescents. In the present study “Balancing Vibrations”, we want to confirm these data on a bigger sample (n=82) and compare to a placebo sport condition. Moreover, the biological effects (neurophysiological, neuroneogenetical, anti-inflammatory, neurocognitive) of whole body vibration (WBV) exercise will be understood in a better way. WBV is mainly used for muscular/ strength training in rehabilitation clinics, but is also well established as a training device (“powerplate”) in fitness centers.

We have changed the title of the study on 2nd of February 2018 to make clearer the entire spectrum of our investigations. The ethics committee was informed.

We decribed the intervention and the CG treatment more precisely on 2nd of February 2018. Participants are supposed to attend the training at least 4 times but they can also attend 5 times.

At the 2nd of February 2018 the primary endpoint was reduced to the expert rating and the self rating was made a secondary endpoint.

At the 2nd of February 2018 the measurements were slightly adjusted. The ethivs committee was informed.

At the 2nd of February 2018, the minimum age was changed to 13 years. Till that change no participants below 13 years of age had been included. Lifting the minimum age allows to capture self rated depression symptoms with BDI which is normed from age 13.

At the 2nd of February 2018, the targeted sample size was reduced to 82. The primary research question is about change in CDRS scores. This can be evaluated best with an ANCOVA model using baseline values as covariate. In such a model, a mean difference of d=.5 can be shown with a probability of 80 % (p=.05) in a sample of 82 (equally distributed in the two groups).

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Brief Summary in Scientific Language

Antidepressant effects of high-frequent exercise (whole body vibration ) as add-on therapy to ”treatment as usual”. Underlying mechanisms of action of exercise therapy in depression. Neurophysiological differences between short-term effects of a single exercise intervention and long-term therapeutic effects of a 6 weeks training program.

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Organizational Data

  •   DRKS00011772
  •   2017/03/20
  •   [---]*
  •   yes
  •   Approved
  •   15-426, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

  •   U1111-1193-4116 
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Health Condition or Problem studied

  •   F32 -  Depressive episode
  •   F33 -  Recurrent depressive disorder
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Interventions/Observational Groups

  •   Whole Body Vibration: 4-5 times week, 30 minutes each intervention, duration of Intervention 6 weeks.
  •   Placebo-condition (myofascial relaxation training): 4-5 times a week for 30 minutes. No muscular activation, intervention focus on personal attention and social factors of sports. Duration: 6 weeks (as WBV Group)
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist, assessor, data analyst
  •   Placebo
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

- zu t0, t2 (after 6 weeks), t3 (after 14 weeks) und t4 (after 20 weeks): CDRS-R (Children Depression Rating Scale - Revised), blinded clinician rating

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Secondary Outcome

- t0, t2, t3, t4: Becks Depressions inventar (BDI)
- t0, t2: Saliva Cortisoll,
- t0, t2, t3: Cytokines (IL-6, TNF Alpha), BDNF, IGF 1 (Blood),
- t0, t2, t3: Neurocognition (CANTAB®)
- t0: K-SADS (ICD-10 Assessment IV)
- t0, t2, t3, t4: other questionnaires (CTQ (Child Trauma questionnaire), EZK (Eigenzustandsskala), WKV (wahrgenommene körpergebunden Verfassung), MSES (Magglinger Sport Enjoyment Scale), CBCL (Child Behavior Checklist), YSR (Youth Self Report), JTCI( Junior Temperament Character Inventory), DISYPS SBB-DES (Depression Self Rating scale), PHOKI (Phobias), DIKJ (Depressions inventar children and adolescents), Collins (Self perception), PACES (movement), Sportmotivation, DISYPS FBB-DES, SSV und ADHS (other Rating by parents and nurses about MDD, ADHD and social behavior disorder), SES (socioeconomic Status)
-t0, t2, t3: neurophysiological Parameters (TMS-EEG)
- t0, t3: cMRT
- t0: BDNF Polymorphisms

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2017/05/22
  •   82
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

- participants have to meet ICD-10 criteria of depressive disorder (ICD-F32,ICD-F33)
- recidivating depressive disorder
- bipolar disorder with actual depressive Episode without psychotic symptoms
- age 13 to 18
- informed consent from participants and participants’ parents
- no medication or on stable Long-term medication

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Exclusion Criteria

- schizophrenia, personality disorders, autism spectrum disorders, other psychotic disorders, schizo-affective disorder, acute suicidality
- unsufficient german language skills
- IQ < 70
- Epilepsy (of subject current or in medical history, or of relatives
- serious head injuries and head sugeries
- Current substance abuse
- Body Mass Index < 16 kg/sqm
- diseases causing restrictions to physical activity and the use of vibration devices,
malignant diseases
- permanent long-term psychiatric medication or medication with inherent psychotropic effects (anticonvulsants, steroids, methylphenidate, amphetamine, antidepressants, neuroleptics, benzodiazepines, mood-stabilizer)
- Patients with Morbus Addison or non-substituted hypothyroidism
- Current pregnancy
- metal implants (e.g. pacemaker implantation)
coffee and cigarette consumption 24 hours until neurophysiological investigations start
- intake of stimulants medication the day of Investigation or 48 h Prior to neurophysiological and MRI Investigation in case of Retard medication

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Addresses

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    • Uniklinik Köln, Klinik und Poliklinik für Psychiatrie, Psychosomatik und Psychotherapie des Kindes- und Jugendalters
    • Robert-Koch-Str. 10
    • 50931  Köln
    • Germany
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    • Kinder- und Jugendpsychiatrie
    • Mr.  Prof. Dr.  Stephan  Bender 
    • Robert-Koch-Straße
    • 10  Köln
    • Germany
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    • Katholische Hochschule NRW
    • Ms.  Prof. Dr.  Nicola  Grossheinrich 
    • Robert-Schumann-Straße 25
    • 52066  Aachen
    • Germany
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    • Gemeinschaftskrankenhaus Herdecke, Klinik für Kinder- und Jugendpsychiatrie
    • Mr.  Prof. Dr.  Oliver  Fricke 
    • Gerhard-Kienle-Weg 4
    • 58313  Herdecke
    • Germany
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    • Uniklinik Köln, Klinik und Poliklinik für Kinderheilkunde und Jugendmedizinund UniReha GmbH Zentrum für Prävention und Rehabilitation
    • Mr.  Prof. Dr.  Eckhard  Schönau 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
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    • Deutsche Sporthochschule KölnInstitut für Kreislaufforschung und Sportmedizin
    • Mr.  Prof. Dr.  Wilhelm  Bloch 
    • Am Sportpark Müngersdorf 6
    • 50933  Köln
    • Germany
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    • Head Research Group Comparative MedicineHead CMMC Animal FacilityCenter for Molecular Medicine, University of Cologne (CMMC)
    • Ms.  PD Dr.  Esther  Mahabir-Brenner 
    • CMMC Research Building, Bldg. 66, Robert-Koch-Str. 21
    • 50933  Köln
    • Germany
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    • Lehrstuhl für Biologische Psychologie, Universität Dresden
    • Mr.  Prof. Dr.  Clemens  Kirschbaum 
    • Zellescher Weg 19
    • 01069   Dresden
    • Germany
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    • IMSIE- Institut für Medizinische Statistik, Informatik und Epidemiologie
    • Mr.  Prof. Dr.  Martin  Hellmich 
    • Universitätsklinikum Köln (AöR) - Gebäude 22
    • 50937  Köln
    • Germany
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    • Uniklinik Köln, Klinik für Kinder- und Jugendpsychiatrie und -psychotherapie
    • Ms.  Dr.  Heidrun-Lioba  Wunram 
    • Robert-Koch-Straße 10
    • 50931  Köln
    • Germany
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    • Uniklinik Köln, Klinik für Kinder- und Jugendpsychiatrie und -psychotherapie
    • Ms.  M. Sc. Psychologie  Lea  Biermann 
    • Robert-Koch-Straße 10
    • 50931  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Marga und Walter Boll-Stiftung
    • Marie-Curie-Str. 8
    • 50170  Kerpen
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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