Clinical trial NCT03466112: Aerobic Exercise for the Improvement of Cognition and Enhancement of Recovery in Post-acute Schizophrenia
Official title: Aerobic Exercise for the Improvement of Cognition and Enhancement of Recovery in Post-acute Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: exercise
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
Collaborators: name: RWTH Aachen University
name: Charite University, Berlin, Germany
name: Heinrich-Heine University, Duesseldorf
name: Central Institute of Mental Health, Mannheim
First posted: 2018-03-15
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The study investigates the efficacy of aerobic exercise on cognitive performance and brain plasticity in schizophrenia.

Detailed description: This multi-center, two-arm, parallel-group, randomized placebo-controlled add-on clinical trial investigates the efficacy of aerobic exercise on cognitive performance and brain plasticity in schizophrenia. The aim is the enhancement of recovery with the use of 26 weeks of continuos endurance training (aerobic exercise) with stationary bicycles or a balance and tone program consisting of exercises for flexibility, core strength, balance and relaxation. Followed by a follow-up period of 26 weeks.

Eligibility criteria: Inclusion Criteria:

* Informed consent given by the subject; DSM-IV-TR diagnosis of schizophrenic psychosis (295.10-30, 295.90); age 18 to 65 years, male or female; PANSS at baseline: total score ≤ 75, proper contraception in female patients of childbearing potential; treatment with one or two antipsychotics in a stable dose of at least two weeks, body mass index between 18 and 40.

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.

Primary outcomes:
measure: all-cause discontinuation
timeFrame: 12 months (at baseline, day 14, 68, 98, 140, 182, 196, 273 and day 365)
Secondary outcomes:
measure: improvement in neurocognition (VLMT)
timeFrame: 12 months (at baseline, day 98, day 182 and day 365)
measure: improvement in neurocognition (DSST)
timeFrame: 12 months (at baseline, day 98, day 182 and day 365)
measure: improvement in neurocognition (TMT)
timeFrame: 12 months (at baseline, day 98, day 182 and day 365)
measure: improvement in neurocognition (B-CATS)
timeFrame: 12 months (at baseline, day 98, day 182 and day 365)
measure: improvement in neurocognition (MASC)
timeFrame: 12 months (at baseline, day 98, day 182 and day 365)
measure: improvement in psychopathology (PANSS)
timeFrame: 12 months (At baseline, day 98, 182 and day 365)
measure: improvement in psychopathology (CGI)
timeFrame: 12 months (at baseline, day 14, 68, 98, 140, 182, 196, 273 and day 365)
measure: improvement in psychopathology (SOFAS)
timeFrame: 12 months (at baseline, day 14, 68, 98, 140, 182, 196, 273 and day 365)
measure: improvement in psychopathology (GAF)
timeFrame: 12 months (At baseline, day 98, 182 and day 365)
measure: improvement in psychopathology (BSI-53)
timeFrame: 12 months (At baseline, day 98, 182 and day 365)
measure: improvement in psychopathology (CDSS)
timeFrame: 12 months (at baseline, day 14, 68, 98, 140, 182, 196, 273 and day 365)
measure: improvement in social and occupational functioning (UPSA-B)
timeFrame: 12 months (at baseline, day 98, day 182 and day 365)
measure: improvement in social and occupational functioning (FROGS)
timeFrame: 12 months (at baseline, day 98, day 182 and day 365)
measure: improvement in social and occupational functioning (PSP)
timeFrame: 12 months (at baseline, day 98, day 182 and day 365)
measure: improvement in quality of life
timeFrame: 12 months (at baseline, day 182 and day 365)
measure: improvement in body mass index (BMI)
timeFrame: 12 months (at baseline, day 14, 68, 98, 140, 182, 196, 273 and day 365)
measure: change of connectivity analysis (MRI of the brain)
timeFrame: 12 months (at baseline, day 98, day 182 and day 365)
measure: change of volumes of brain regions (MRI)
timeFrame: 12 months (at baseline, day 98, day 182 and day 365)
measure: change of brain function (MRI)
timeFrame: 12 months (at baseline, day 98, day 182 and day 365)
measure: improvement of endurance capacity
timeFrame: 12 months (at baseline, day 98, day 182 and day 365)
measure: change of medication and attitude of the study participants to therapy (DAI)
timeFrame: 12 months (at baseline, day 98, day 182 and day 365)
measure: change of medication and attitude of the study participants to therapy (SES)
timeFrame: 12 months (at baseline, day 98, day 182 and day 365)
measure: improvement in metabolic parameters
timeFrame: 12 months (at baseline, day 98, day 182 and day 365)
measure: urine (testing pregnancy and drug abuse)
timeFrame: baseline
measure: gene expression
timeFrame: baseline
measure: change of genome-wide epigenetics
timeFrame: 12 months (at baseline, day 98, day 182 and day 365)
measure: change of proteomics
timeFrame: 12 months (at baseline, day 98, day 182 and day 365)
measure: change of BDNF level
timeFrame: 12 months (at baseline, day 98, day 182 and day 365)
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Ludwig-Maximilians-University of Munich
state: Bavaria
Study officials:
affiliation: LMU Munich
name: Peter G. Falkai, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maurus I, Roell L, Keeser D, Papazov B, Papazova I, Lembeck M, Roeh A, Wagner E, Hirjak D, Malchow B, Ertl-Wagner B, Stoecklein S, Hasan A, Schmitt A, Meyer-Lindenberg A, Falkai P. Fitness is positively associated with hippocampal formation subfield volumes in schizophrenia: a multiparametric magnetic resonance imaging study. Transl Psychiatry. 2022 Sep 16;12(1):388. doi: 10.1038/s41398-022-02155-x.
citation: Roell L, Maurus I, Keeser D, Karali T, Papazov B, Hasan A, Schmitt A, Papazova I, Lembeck M, Hirjak D, Sykorova E, Thieme CE, Muenz S, Seitz V, Greska D, Campana M, Wagner E, Loehrs L, Stoecklein S, Ertl-Wagner B, Poemsl J, Roeh A, Malchow B, Keller-Varady K, Meyer-Lindenberg A, Falkai P. Association between aerobic fitness and the functional connectome in patients with schizophrenia. Eur Arch Psychiatry Clin Neurosci. 2022 Oct;272(7):1253-1272. doi: 10.1007/s00406-022-01411-x. Epub 2022 Apr 30.
citation: Maurus I, Hasan A, Schmitt A, Roeh A, Keeser D, Malchow B, Schneider-Axmann T, Hellmich M, Schmied S, Lembeck M, Keller-Varady K, Papazova I, Hirjak D, Topor CE, Walter H, Mohnke S, Vogel BO, Wolwer W, Schneider F, Henkel K, Meyer-Lindenberg A, Falkai P. Aerobic endurance training to improve cognition and enhance recovery in schizophrenia: design and methodology of a multicenter randomized controlled trial. Eur Arch Psychiatry Clin Neurosci. 2021 Mar;271(2):315-324. doi: 10.1007/s00406-020-01175-2. Epub 2020 Aug 3.