F20
Conditions
Interventions
Group 1: continuous aerobic endurance training with stationay bicycles (3 x 40-50 min/week, 26 weeks)
Group 2: balance and tone program (3 x 40-50 min/week, 26 weeks: warm-up, flexibility, core streng
Sponsors
Zentralinstitut für Seelische Gesundheit
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: informed consent, diagnosis of schizophrenia according to DSM-IV-TR, total postive and negative symptom scale score 75 or lower, reliable contraception in women of child-bearing age, Body Mass Index between 18 und 40, stable dose for at least two weeks of one or two antipsychotics including clozapine.
Exclusion criteria
Exclusion criteria: lack of accountability, positive urine drug-screening for illicit drugs at screening (except benzodiazepines), serious suicidal risk at screening visit, other relevant interferences of axis 1 according to diagnostic evaluation (MINI), other relevant neurological or other medical disorders, pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause discontinuation, 9 time points over 1 year duration of the trial, defined by any of the following conditions: (1) relevant worsening of symptoms (exceeding PANSS total score of 75), (2) serious side effects, (3) not keeping appointments to intervention or diagnostic sessions as scheduled for more than 6 consecutive weeks and/or (4) not being traceable despite extensive efforts by the intervention team to re-engage the patient throughout the entire intended treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| Significant improvement in cognition (baseline, after 14 weeks, after 26 weeks, after 1 year, University of California San Diego Performance-based Skills Assessment (UPSA-B), verbal fluency test of Brief Cognitive Assessment Tool for Schizophrenia (B-CATS), Digit symbol substitution test (DSST), Verbal Learning and Memory Test (VLMT), Digit Span, Trail Making Test A and B (TMT), Facial Affect Recognition-Test (PFA), Movie for the Assessment of Social Cognition (MASC)), psychopathology (baseline, after 14 weeks, after 26 weeks, after 1 year (plus 5 additional time points for CGI), Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression (CGI), Brief Symptom Inventory (BSI-53)), everyday functioning (baseline, after 14 weeks, after 26 weeks, after 1 year (plus 5 additional time points for SOFAS), Functional Remission of General Schizophrenia (FROGS), Personal and Social Performance Scale (PSP), Global Assessment of Functioning Scale (GAF), Social and Occupational Functioning Assessment Scale (SOFAS)), Quality of Life (baseline, after 26 weeks, after 1 year, World Health Organization Quality of Life-Bref (WHOQOL-Bref), vital signs (10 time points, measurement of heart rate, blood pressure, body mass, waist circumference), impact on structural and functional magnetic resonance imaging parameters (MRI) (baseline, after 14 weeks, after 26 weeks, after 1 year, structural, functional, resting state MRI und Diffusion Tensor Imaging), metabolic parameters (baseline, after 14 weeks, after 26 weeks, after 1 year, analyses of blood samples), biomarker (baseline, after 14 weeks, after 26 weeks, after 1 year, analyses of blood samples regarding gene expression, epigenetics, proteomics, BDNF plasma levels), gene x environment interactions with analyses of blood samples at baseline, cost-effectiveness ratio (baseline, after 14 weeks, after 26 weeks, after 39 weeks, after 1 year with questionnaire), endurance capacity (baseline, after 14 weeks, after 26 weeks, after | — |
Countries
Germany
Contacts
Public ContactMoritz Lembeck
Klinik für Psychiatrie und Psychotherapie
Outcome results
None listed