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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00011772
Enrollment
82
Registered
2017-03-20
Start date
2017-05-22
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F32 F33

Interventions

Group 1: Whole Body Vibration: 4-5 times week, 30 minutes each intervention, duration of Intervention 6 weeks. Group 2: Placebo-condition (myofascial relaxation training): 4-5 times a week for 30 minu

Sponsors

Uniklinik Köln, Klinik und Poliklinik für Psychiatrie, Psychosomatik und Psychotherapie des Kindes- und Jugendalters
Lead Sponsor

Eligibility

Sex/Gender
All
Age
13 Years to 18 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
- 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

Secondary

MeasureTime frame
- 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

Countries

Germany

Contacts

Public ContactSarah Klomfass

Uniklinik Köln, Klinik für Kinder- und Jugendpsychiatrie und -psychotherapie

sarah.klomfass@uk-koeln.de+49-221-478-39079

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 6, 2026