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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- IRCCS San Raffaele
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Cognitive performance
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients diagnosed with Schizophrenia
- •Age 18-65 years
- •Psychopathological stability
- •Ability to provide informed consent
Exclusion Criteria
- •Comorbidity with intellectual disability and neurological disorders.
- •Ongoing treatment with CR or AE.
- •Specific contraindications for AE.
Arms & Interventions
Cognitive Remediation (CR)
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
Intervention: Cognitive Remediation (CR) (Behavioral)
Cognitive Remediation (CR)
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
Intervention: Cognitve Remediation + Aerobic Exercise (Other)
Aerobic Exercise (AE)
AE consists of 45 minutes of cycling twice a week, with 15 minutes of warm up pre and post session
Intervention: Aerobic Exercise (Behavioral)
Aerobic Exercise (AE)
AE consists of 45 minutes of cycling twice a week, with 15 minutes of warm up pre and post session
Intervention: Cognitve Remediation + Aerobic Exercise (Other)
Cognitive Remediation and Aerobic Exercise
this intervention is composed by both cognitive remediation and aerobic exercise
Intervention: Cognitive Remediation (CR) (Behavioral)
Cognitive Remediation and Aerobic Exercise
this intervention is composed by both cognitive remediation and aerobic exercise
Intervention: Aerobic Exercise (Behavioral)
Cognitive Remediation and Aerobic Exercise
this intervention is composed by both cognitive remediation and aerobic exercise
Intervention: Cognitve Remediation + Aerobic Exercise (Other)
Outcomes
Primary Outcomes
Cognitive performance
Time Frame: 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 Outcomes
- Psychopathology assessment(7 months)
- Quality of Life assessment(7 months)
- Daily functioning assessment(7 months)
- Body Mass Index (BMI)(7 months)
- Diffusion Tensor Imaging (DTI)(4 months)
- Waist circumference(7 months)
- Blood pressure(7 months)
- Metabolic indices(7 months)
Investigators
Marta Bosia
Prof.ssa
IRCCS San Raffaele