Effects of Aerobic Exercise, Cognitive Remediation and Combined Intervention in Schizophrenia
NCT ID: NCT06810362
Last Updated: 2025-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2019-01-10
2023-09-02
Brief Summary
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Detailed Description
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* Primary objective: o assess, through a randomized controlled trial (RCT), the efficacy and feasibility of a combined intervention (CR + AE) in patients with schizophrenia. The primary outcome measure will be cognitive performance, while secondary outcomes will include scales for the assessment of psychopathology, daily functioning, and quality of life.
* Secondary objectives: to evaluate changes in bio-physical and laboratory metabolic parameters, as well as in neurotrophic and neuroinflammatory factors. Furthermore, multimodal magnetic resonance imaging (MRI) parameters will be evaluated after the interventions, and their relationship with observed cognitive improvements will be explored.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Cognitive Remediation (CR)
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
Cognitive Remediation (CR)
The CR consists of three 1-hour sessions per week of domain-specific computerized exercises, for a period of 12 weeks, totaling 36 hours
Cognitve Remediation + Aerobic Exercise
Patients performed both CR exercises and cycling
Aerobic Exercise (AE)
AE consists of 45 minutes of cycling twice a week, with 15 minutes of warm up pre and post session
Aerobic Exercise
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
Cognitve Remediation + Aerobic Exercise
Patients performed both CR exercises and cycling
Cognitive Remediation and Aerobic Exercise
this intervention is composed by both cognitive remediation and aerobic exercise
Cognitive Remediation (CR)
The CR consists of three 1-hour sessions per week of domain-specific computerized exercises, for a period of 12 weeks, totaling 36 hours
Aerobic Exercise
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
Cognitve Remediation + Aerobic Exercise
Patients performed both CR exercises and cycling
Interventions
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Cognitive Remediation (CR)
The CR consists of three 1-hour sessions per week of domain-specific computerized exercises, for a period of 12 weeks, totaling 36 hours
Aerobic Exercise
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
Cognitve Remediation + Aerobic Exercise
Patients performed both CR exercises and cycling
Eligibility Criteria
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Inclusion Criteria
2. Age 18-65 years
3. Psychopathological stability
4. Ability to provide informed consent
Exclusion Criteria
2. Ongoing treatment with CR or AE.
3. Specific contraindications for AE.
18 Years
65 Years
ALL
No
Sponsors
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IRCCS San Raffaele
OTHER
Responsible Party
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Marta Bosia
Prof.ssa
Principal Investigators
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Marta Bosia, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Vita-Salute San Raffaele
Locations
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IRCCS San Raffaele
Milan, MI, Italy
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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GR-2016-02361538
Identifier Type: -
Identifier Source: org_study_id
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