Clinical trial NCT06810362: Effects of Aerobic Exercise, Cognitive Remediation and Combined Intervention in Schizophrenia
Official title: Walking Our Way to a Healthier Brain: a Randomized Controlled Trial to Evaluate the Effects of Aerobic Exercise, Cognitive Remediation and Combined Intervention in Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Psychosis
Keywords: cognition
pshysical activity
metabolic syndrome
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2025-02-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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)
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cognitive performance
timeFrame: 7 months
Secondary outcomes:
measure: Psychopathology assessment
timeFrame: 7 months
measure: Quality of Life assessment
timeFrame: 7 months
measure: Daily functioning assessment
timeFrame: 7 months
measure: Body Mass Index (BMI)
timeFrame: 7 months
measure: Diffusion Tensor Imaging (DTI)
timeFrame: 4 months
measure: Waist circumference
timeFrame: 7 months
measure: Blood pressure
timeFrame: 7 months
measure: Metabolic indices
timeFrame: 7 months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS San Raffaele
state: MI
Study officials:
affiliation: Vita-Salute San Raffaele
name: Marta Bosia, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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