Effects of Aerobic Exercise, Cognitive Remediation and Combined Intervention in Schizophrenia

NCT06810362 | Completed

• 1 other identifier: GR-2016-02361538
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Tracking down the efficacy of a combined intervention of cognitive remediation (CR) and phisycal activity (aerobic exercise, AE) in patients diagnosed with schizophrenia

Conditions

Schizophrenia; Psychosis

Keywords

cognition; pshysical activity; metabolic syndrome

Outcome Measures

Primary Outcomes (1)

• Cognitive performance

  Cognition is assessed through the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB): a neuropsychological battery developed for the assessment of the main cognitive domains impaired in schizophrenia. Range T-values: 20-80. Higher values mean a better score

  7 months

Secondary Outcomes (8)

• Psychopathology assessment

  7 months

• Quality of Life assessment

  7 months

• Daily functioning assessment

  7 months

• Body Mass Index (BMI)

  7 months

• Diffusion Tensor Imaging (DTI)

  4 months

Study Arms (3)

Cognitive Remediation (CR)

ACTIVE COMPARATOR

CR consists of three 1-hour sessions per week of domain-specific computerized exercises, over a 12-week period, for a total of 36 hours

Behavioral: Cognitive Remediation (CR); Other: Cognitve Remediation + Aerobic Exercise

Aerobic Exercise (AE)

ACTIVE COMPARATOR

AE consists of 45 minutes of cycling twice a week, with 15 minutes of warm up pre and post session

Behavioral: Aerobic Exercise; Other: Cognitve Remediation + Aerobic Exercise

Cognitive Remediation and Aerobic Exercise

EXPERIMENTAL

this intervention is composed by both cognitive remediation and aerobic exercise

Behavioral: Cognitive Remediation (CR); Behavioral: Aerobic Exercise; Other: Cognitve Remediation + Aerobic Exercise

Interventions

Cognitive Remediation (CR) BEHAVIORAL

The CR consists of three 1-hour sessions per week of domain-specific computerized exercises, for a period of 12 weeks, totaling 36 hours

Cognitive Remediation (CR); Cognitive Remediation and Aerobic Exercise

Aerobic Exercise BEHAVIORAL

Aerobic exercise consists in two session per week of cycling. Each session lasts for 45 min, with 15 min of warm up pre and post session

Aerobic Exercise (AE); Cognitive Remediation and Aerobic Exercise

Cognitve Remediation + Aerobic Exercise OTHER

Patients performed both CR exercises and cycling

Aerobic Exercise (AE); Cognitive Remediation (CR); Cognitive Remediation and Aerobic Exercise

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with Schizophrenia
• Age 18-65 years
• Psychopathological stability
• Ability to provide informed consent

You may not qualify if:

• Comorbidity with intellectual disability and neurological disorders.
• Ongoing treatment with CR or AE.
• Specific contraindications for AE.

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCS San Raffaele

Milan, MI, 20100, Italy

Location

Related Publications (12)

• Heinrichs DW, Hanlon TE, Carpenter WT Jr. The Quality of Life Scale: an instrument for rating the schizophrenic deficit syndrome. Schizophr Bull. 1984;10(3):388-98. doi: 10.1093/schbul/10.3.388.

  PMID: 6474101 BACKGROUND

• Mausbach BT, Harvey PD, Goldman SR, Jeste DV, Patterson TL. Development of a brief scale of everyday functioning in persons with serious mental illness. Schizophr Bull. 2007 Nov;33(6):1364-72. doi: 10.1093/schbul/sbm014. Epub 2007 Mar 6.

  PMID: 17341468 BACKGROUND

• Kay SR, Fiszbein A, Opler LA. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull. 1987;13(2):261-76. doi: 10.1093/schbul/13.2.261.

  PMID: 3616518 BACKGROUND

• Nuechterlein KH, Green MF, Kern RS, Baade LE, Barch DM, Cohen JD, Essock S, Fenton WS, Frese FJ 3rd, Gold JM, Goldberg T, Heaton RK, Keefe RS, Kraemer H, Mesholam-Gately R, Seidman LJ, Stover E, Weinberger DR, Young AS, Zalcman S, Marder SR. The MATRICS Consensus Cognitive Battery, part 1: test selection, reliability, and validity. Am J Psychiatry. 2008 Feb;165(2):203-13. doi: 10.1176/appi.ajp.2007.07010042. Epub 2008 Jan 2.

  PMID: 18172019 BACKGROUND

• Cavallaro R, Anselmetti S, Poletti S, Bechi M, Ermoli E, Cocchi F, Stratta P, Vita A, Rossi A, Smeraldi E. Computer-aided neurocognitive remediation as an enhancing strategy for schizophrenia rehabilitation. Psychiatry Res. 2009 Oct 30;169(3):191-6. doi: 10.1016/j.psychres.2008.06.027. Epub 2009 Sep 9.

  PMID: 19740550 BACKGROUND

• Cassilhas RC, Tufik S, de Mello MT. Physical exercise, neuroplasticity, spatial learning and memory. Cell Mol Life Sci. 2016 Mar;73(5):975-83. doi: 10.1007/s00018-015-2102-0. Epub 2015 Dec 8.

  PMID: 26646070 BACKGROUND

• Firth J, Cotter J, Elliott R, French P, Yung AR. A systematic review and meta-analysis of exercise interventions in schizophrenia patients. Psychol Med. 2015 May;45(7):1343-61. doi: 10.1017/S0033291714003110. Epub 2015 Feb 4.

  PMID: 25650668 BACKGROUND

• Bryce S, Sloan E, Lee S, Ponsford J, Rossell S. Cognitive remediation in schizophrenia: A methodological appraisal of systematic reviews and meta-analyses. J Psychiatr Res. 2016 Apr;75:91-106. doi: 10.1016/j.jpsychires.2016.01.004. Epub 2016 Jan 5.

  PMID: 26828372 BACKGROUND

• Laursen TM, Munk-Olsen T, Vestergaard M. Life expectancy and cardiovascular mortality in persons with schizophrenia. Curr Opin Psychiatry. 2012 Mar;25(2):83-8. doi: 10.1097/YCO.0b013e32835035ca.

  PMID: 22249081 BACKGROUND

• Bowie CR, Reichenberg A, Patterson TL, Heaton RK, Harvey PD. Determinants of real-world functional performance in schizophrenia subjects: correlations with cognition, functional capacity, and symptoms. Am J Psychiatry. 2006 Mar;163(3):418-25. doi: 10.1176/appi.ajp.163.3.418.

  PMID: 16513862 BACKGROUND

• Malchow B, Keeser D, Keller K, Hasan A, Rauchmann BS, Kimura H, Schneider-Axmann T, Dechent P, Gruber O, Ertl-Wagner B, Honer WG, Hillmer-Vogel U, Schmitt A, Wobrock T, Niklas A, Falkai P. Effects of endurance training on brain structures in chronic schizophrenia patients and healthy controls. Schizophr Res. 2016 Jun;173(3):182-191. doi: 10.1016/j.schres.2015.01.005. Epub 2015 Jan 23.

  PMID: 25623601 BACKGROUND

• Penades R, Pujol N, Catalan R, Massana G, Rametti G, Garcia-Rizo C, Bargallo N, Gasto C, Bernardo M, Junque C. Brain effects of cognitive remediation therapy in schizophrenia: a structural and functional neuroimaging study. Biol Psychiatry. 2013 May 15;73(10):1015-23. doi: 10.1016/j.biopsych.2013.01.017. Epub 2013 Feb 26.

  PMID: 23452665 BACKGROUND

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Metabolic Syndrome

Interventions

Cognitive Remediation; Exercise

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Marta Bosia, MD, PhD

  Vita-Salute San Raffaele

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.ssa

Model Details: All patients will be randomized in a 1:1:1 ratio to three parallel treatment arms: experimental intervention (CR + AE) and two active comparison arms (CR and AE)

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: February 5, 2025
• Study Start: January 10, 2019
• Primary Completion: September 2, 2023
• Study Completion: September 2, 2023
• Last Updated: February 5, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)