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Completed

NCT Number: NCT06810362

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

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

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Key information

Conditions

Schizophrenia Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Mental Disorders Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases Psychosis Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS San Raffaele

Milan, MI, 20100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cognitive Remediation (CR)

Behavioral

The CR consists of three 1-hour sessions per week of domain-specific computerized exercises, for a period of 12 weeks, totaling 36 hours

Aerobic Exercise

Behavioral

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

Cognitve Remediation + Aerobic Exercise

Other

Patients performed both CR exercises and cycling

Primary outcomes

  1. 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

  1. Psychopathology assessment

    Time frame: 7 months

    Psychopathology is assessed trough the scale Positive and Negative Syndrome Scale (PANSS). Values range 1-7, higher scores mean worse functioning

  2. Quality of Life assessment

    Time frame: 7 months

    Quality of life is assessed through the scale Quality of Life Scale (QLS). Values range 0-6. Higher values mean better functioning

  3. Daily functioning assessment

    Time frame: 7 months

    daily functioning is assessed through the task UCSD Performance-based skill assessment (UPSA-B). Values range 0-1. 1 means better functioning

  4. Body Mass Index (BMI)

    Time frame: 7 months

    Physical fitness is assessed through the evaluation of BMI (kg/m^2)

  5. Diffusion Tensor Imaging (DTI)

    Time frame: 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

  6. Waist circumference

    Time frame: 7 months

    Waist circumference (cm) is assessed for the evaluation of physical fitness

  7. Blood pressure

    Time frame: 7 months

    Systolic and diastolic blood pressure (mm Hg) are assessed for the evaluation of metabolic syndrome and physical fitness

  8. Metabolic indices

    Time frame: 7 months

    Tryglicerides, HDL cholesterol and fasting plasma glucose are assessed through blood sampling. All of them are measured in mg/dL

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study 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

Acronym: C-CARE

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Feb 5, 2025
Registry last updated
Feb 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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