NCT06810362

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: IRCCS San Raffaele · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Schizophrenia
• Psychosis

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive Remediation (CR)	The CR consists of three 1-hour sessions per week of domain-specific computerized exercises, for a period of 12 weeks, totaling 36 hours
BEHAVIORAL	Aerobic Exercise	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
OTHER	Cognitve Remediation + Aerobic Exercise	Patients performed both CR exercises and cycling

Timeline

• Start date: 2019-01-10
• Primary completion: 2023-09-02
• Completion: 2023-09-02
• First posted: 2025-02-05
• Last updated: 2025-02-05

Locations

1 site across 1 country: Italy