Effects of Aerobic Exercise, Cognitive Remediation and Combined Intervention in Schizophrenia (C-CARE)

San Donato Group (GSD)

Status: Completed

Conditions: Psychosis; Schizophrenia

Treatments: Other: Cognitve Remediation + Aerobic Exercise; Behavioral: Aerobic Exercise; Behavioral: Cognitive Remediation (CR)

Study type: Interventional

Funder types: Other

Identifiers

NCT06810362

GR-2016-02361538

Details and patient eligibility

About

Tracking down the efficacy of a combined intervention of cognitive remediation (CR) and phisycal activity (aerobic exercise, AE) in patients diagnosed with schizophrenia

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups

Cognitive Remediation (CR)

Active Comparator group

Description:

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

Treatment:

Behavioral: Cognitive Remediation (CR)

Other: Cognitve Remediation + Aerobic Exercise

Aerobic Exercise (AE)

Active Comparator group

Description:

AE consists of 45 minutes of cycling twice a week, with 15 minutes of warm up pre and post session

Treatment:

Behavioral: Aerobic Exercise

Other: Cognitve Remediation + Aerobic Exercise

Cognitive Remediation and Aerobic Exercise

Experimental group

Description:

this intervention is composed by both cognitive remediation and aerobic exercise

Treatment:

Behavioral: Cognitive Remediation (CR)

Behavioral: Aerobic Exercise

Other: Cognitve Remediation + Aerobic Exercise