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Tracking down the efficacy of a combined intervention of cognitive remediation (CR) and phisycal activity (aerobic exercise, AE) in patients diagnosed with schizophrenia
The investigators will address the following objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Cognitive Remediation and Aerobic Exercise | Experimental | this intervention is composed by both cognitive remediation and aerobic exercise |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Psychopathology assessment | Psychopathology is assessed trough the scale Positive and Negative Syndrome Scale (PANSS). Values range 1-7, higher scores mean worse functioning | 7 months |
| Quality of Life assessment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marta Bosia, MD, PhD | Vita-Salute San Raffaele | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS San Raffaele | Milan | MI | 20100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 6474101 | Background | 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. | |
| 17341468 | 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. |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
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| ID | Term |
|---|---|
| D000072466 | Cognitive Remediation |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D009043 | Motor Activity |
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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)
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| 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 |
|
| Cognitve Remediation + Aerobic Exercise | Other | Patients performed both CR exercises and cycling |
|
Quality of life is assessed through the scale Quality of Life Scale (QLS). Values range 0-6. Higher values mean better functioning
| 7 months |
| Daily functioning assessment | daily functioning is assessed through the task UCSD Performance-based skill assessment (UPSA-B). Values range 0-1. 1 means better functioning | 7 months |
| Body Mass Index (BMI) | Physical fitness is assessed through the evaluation of BMI (kg/m^2) | 7 months |
| Diffusion Tensor Imaging (DTI) | DTI was performed to assess the integrity of brain white matter and to estimate the axonal organization of the brain. Its unit of measure is µm²/ms | 4 months |
| Waist circumference | Waist circumference (cm) is assessed for the evaluation of physical fitness | 7 months |
| Blood pressure | Systolic and diastolic blood pressure (mm Hg) are assessed for the evaluation of metabolic syndrome and physical fitness | 7 months |
| Metabolic indices | Tryglicerides, HDL cholesterol and fasting plasma glucose are assessed through blood sampling. All of them are measured in mg/dL | 7 months |
| 3616518 | 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. |
| 18172019 | 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. |
| 19740550 | 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. |
| 26646070 | 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. |
| 25650668 | 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. |
| 26828372 | 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. |
| 22249081 | 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. |
| 16513862 | 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. |
| 25623601 | 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. |
| 23452665 | 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. |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D009068 |
| Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |