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

IRCCS San Raffaele60 enrolled

Overview

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: * 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Schizophrenia Psychosis

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

Aerobic ExerciseBEHAVIORAL

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 ExerciseOTHER

Patients performed both CR exercises and cycling

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients diagnosed with Schizophrenia 2. Age 18-65 years 3. Psychopathological stability 4. Ability to provide informed consent Exclusion Criteria: 1. Comorbidity with intellectual disability and neurological disorders. 2. Ongoing treatment with CR or AE. 3. Specific contraindications for AE.

Locations (1)

IRCCS San Raffaele

Milan, MI, Italy

Outcomes

Primary Outcomes

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

Time frame: 7 months

Secondary Outcomes

Psychopathology assessment

Psychopathology is assessed trough the scale Positive and Negative Syndrome Scale (PANSS). Values range 1-7, higher scores mean worse functioning

Time frame: 7 months

Quality of Life assessment

Quality of life is assessed through the scale Quality of Life Scale (QLS). Values range 0-6. Higher values mean better functioning

Time frame: 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

Time frame: 7 months

Body Mass Index (BMI)

Physical fitness is assessed through the evaluation of BMI (kg/m\^2)

Time frame: 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

Time frame: 4 months

Waist circumference

Waist circumference (cm) is assessed for the evaluation of physical fitness

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.