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

January 31, 2025 updated by: Marta Bosia, IRCCS San Raffaele

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • MI
      • Milan, MI, Italy, 20100
        • IRCCS San Raffaele

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
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
Other: Cognitve Remediation + Aerobic Exercise
Patients performed both CR exercises and cycling
Active Comparator: Aerobic Exercise (AE)
AE consists of 45 minutes of cycling twice a week, with 15 minutes of warm up pre and post session
Other: Cognitve Remediation + Aerobic Exercise
Patients performed both CR exercises and cycling
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
Experimental: Cognitive Remediation and Aerobic Exercise
this intervention is composed by both cognitive remediation and aerobic exercise
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
Other: Cognitve Remediation + Aerobic Exercise
Patients performed both CR exercises and cycling
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
7 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
7 months
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
7 months
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
7 months
Body Mass Index (BMI)
Time Frame: 7 months
Physical fitness is assessed through the evaluation of BMI (kg/m^2)
7 months
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
4 months
Waist circumference
Time Frame: 7 months
Waist circumference (cm) is assessed for the evaluation of physical fitness
7 months
Blood pressure
Time Frame: 7 months
Systolic and diastolic blood pressure (mm Hg) are assessed for the evaluation of metabolic syndrome and physical fitness
7 months
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
7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Investigators

  • Principal Investigator: Marta Bosia, MD, PhD, Vita-Salute San Raffaele

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2019

Primary Completion (Actual)

September 2, 2023

Study Completion (Actual)

September 2, 2023

Study Registration Dates

First Submitted

January 9, 2025

First Submitted That Met QC Criteria

January 31, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 31, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GR-2016-02361538

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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