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

Not Applicable

Completed

• Conditions: Schizophrenia; Psychosis

• Registration Number: NCT06810362
• Lead Sponsor: IRCCS San Raffaele

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

Detailed Description

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 Timeline

• Study Start: 2019-01-10
• Primary Completion: 2023-09-02
• Study Completion: 2023-09-02
• Status Verified: 2025-01
• Study First Submitted: 2025-01-09
• Study First Submitted QC: 2025-01-31
• Last Update Submitted: 2025-01-31
• Study First Posted: 2025-02-05
• Last Update Posted: 2025-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Cognitive performance	7 months	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

Secondary Outcome Measures

Name	Time	Method
Psychopathology assessment	7 months	Psychopathology is assessed trough the scale Positive and Negative Syndrome Scale (PANSS). Values range 1-7, higher scores mean worse functioning
Quality of Life assessment	7 months	Quality of life is assessed through the scale Quality of Life Scale (QLS). Values range 0-6. Higher values mean better functioning
Daily functioning assessment	7 months	daily functioning is assessed through the task UCSD Performance-based skill assessment (UPSA-B). Values range 0-1. 1 means better functioning
Body Mass Index (BMI)	7 months	Physical fitness is assessed through the evaluation of BMI (kg/m\^2)
Diffusion Tensor Imaging (DTI)	4 months	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
Waist circumference	7 months	Waist circumference (cm) is assessed for the evaluation of physical fitness
Blood pressure	7 months	Systolic and diastolic blood pressure (mm Hg) are assessed for the evaluation of metabolic syndrome and physical fitness
Metabolic indices	7 months	Tryglicerides, HDL cholesterol and fasting plasma glucose are assessed through blood sampling. All of them are measured in mg/dL

Trial Locations

Locations (1)

IRCCS San Raffaele; 🇮🇹 Milan, MI, Italy