NCT03466112

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable schizophrenia

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 19, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 15, 2018

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

March 3, 2022

Status Verified

February 1, 2022

Enrollment Period

5.5 years

First QC Date

February 19, 2018

Last Update Submit

February 15, 2022

Conditions

Schizophrenia

Keywords

exercise

Outcome Measures

Primary Outcomes (1)

  • all-cause discontinuation

    Reason of study discontinuation will be identified. The all-cause-discontinuation questionnaire will be called up 9 times from baseline up to 12 months (compare time frame) including 26 weeks of intervention and 26 weeks follow up period. Reasons are defined as (1) relevant worsening of clinical symptoms (PANSS total score above 75 on cancerous visits for more than 14 days. (2) failure to take the prescribed medication for more than 14 days. (3) Failure to comply scheduled study or diagnostic appointments for more than 6 weeks (4) Patient unavailability despite extensive efforts of the treatment team (5) Withdrawal of patient consent (6) Clinician discontinuation.

    12 months (at baseline, day 14, 68, 98, 140, 182, 196, 273 and day 365)

Secondary Outcomes (28)

  • improvement in neurocognition (VLMT)

    12 months (at baseline, day 98, day 182 and day 365)

  • improvement in neurocognition (DSST)

    12 months (at baseline, day 98, day 182 and day 365)

  • improvement in neurocognition (TMT)

    12 months (at baseline, day 98, day 182 and day 365)

  • improvement in neurocognition (B-CATS)

    12 months (at baseline, day 98, day 182 and day 365)

  • improvement in neurocognition (MASC)

    12 months (at baseline, day 98, day 182 and day 365)

  • +23 more secondary outcomes

Study Arms (2)

endurance training

EXPERIMENTAL

endurance training with stationary bicycles

Other: endurance training

balance and tone program

ACTIVE COMPARATOR

flexibility, core strength, balance, relaxation

Other: balance and tone program

Interventions

endurance trainingOTHER

endurance training with stationary bicycles

Also known as: aerobic exercise
endurance training
balance and tone programOTHER

flexibility, core strength, balance, relaxation

balance and tone program

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ludwig-Maximilians-University of Munich

Munich, Bavaria, 80366, Germany

Location

Related Publications (5)

  • Schwaiger R, Maurus I, Lembeck M, Papazova I, Greska D, Muenz S, Sykorova E, Thieme CE, Vogel BO, Mohnke S, Huppertz C, Roeh A, Keller-Varady K, Malchow B, Walter H, Wolfarth B, Wolwer W, Henkel K, Hirjak D, Schmitt A, Hasan A, Meyer-Lindenberg A, Falkai P, Roell L. Predictors of adherence to exercise interventions in people with schizophrenia. Eur Arch Psychiatry Clin Neurosci. 2024 Sep;274(6):1265-1276. doi: 10.1007/s00406-024-01789-w. Epub 2024 Mar 29.

    PMID: 38551773DERIVED

  • Roell L, Keeser D, Papazov B, Lembeck M, Papazova I, Greska D, Muenz S, Schneider-Axmann T, Sykorova EB, Thieme CE, Vogel BO, Mohnke S, Huppertz C, Roeh A, Keller-Varady K, Malchow B, Stoecklein S, Ertl-Wagner B, Henkel K, Wolfarth B, Tantchik W, Walter H, Hirjak D, Schmitt A, Hasan A, Meyer-Lindenberg A, Falkai P, Maurus I. Effects of Exercise on Structural and Functional Brain Patterns in Schizophrenia-Data From a Multicenter Randomized-Controlled Study. Schizophr Bull. 2024 Jan 1;50(1):145-156. doi: 10.1093/schbul/sbad113.

    PMID: 37597507DERIVED

  • 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.

    PMID: 36114184DERIVED

  • 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.

    PMID: 35488054DERIVED

  • 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.

    PMID: 32748261DERIVED

MeSH Terms

Conditions

SchizophreniaMotor Activity

Interventions

Endurance TrainingExercise

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Peter G. Falkai, Prof. Dr.

    LMU Munich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

February 19, 2018

First Posted

March 15, 2018

Study Start

June 1, 2016

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

March 3, 2022

Record last verified: 2022-02

Locations

DE(1)