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SchizophreniaC-CARENCT06810362

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

A study testing Cognitive Remediation (CR), Aerobic Exercise and Cognitve Remediation + Aerobic Exercise in people with Schizophrenia and Psychosis, run by IRCCS San Raffaele at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Schizophrenia, Psychosis
What is being tested?
Cognitive Remediation (CR), Aerobic Exercise and Cognitve Remediation + Aerobic Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteItaly
Study dates
10 Jan 2019to 2 Sep 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients diagnosed with Schizophrenia
  • Age 18-65 years
  • Psychopathological stability
  • Ability to provide informed consent

Who cannot join

  • Comorbidity with intellectual disability and neurological disorders.
  • Ongoing treatment with CR or AE.
  • Specific contraindications for AE.

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • IRCCS San Raffaele

    Milan, MI, 20100

Other trials in Italy

About this study

Official 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

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

Read the 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.
Being tested
Cognitive Remediation (CR), Aerobic Exercise, Cognitve Remediation + Aerobic Exercise
Keywords
cognition, pshysical activity, metabolic syndrome
Medical subject headings
Schizophrenia, Psychotic Disorders, Metabolic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive Remediation (CR)Behavioural

    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 ExerciseBehavioural

    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 ExerciseOther

    Patients performed both CR exercises and cycling

Study groups in NCT06810362
Study groupRoleWhat they receive
Cognitive Remediation (CR)Active comparatorCR consists of three 1-hour sessions per week of domain-specific computerized exercises, over a 12-week period, for a total of 36 hours
Receives: Behavioral: Cognitive Remediation (CR); Other: Cognitve Remediation + Aerobic Exercise
Aerobic Exercise (AE)Active comparatorAE consists of 45 minutes of cycling twice a week, with 15 minutes of warm up pre and post session
Receives: Behavioral: Aerobic Exercise; Other: Cognitve Remediation + Aerobic Exercise
Cognitive Remediation and Aerobic ExerciseExperimentalthis intervention is composed by both cognitive remediation and aerobic exercise
Receives: Behavioral: Cognitive Remediation (CR); Behavioral: Aerobic Exercise; Other: Cognitve Remediation + Aerobic Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cognitive performance

    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

    Measured: 7 months

Secondary outcomes (8)

  1. Psychopathology assessment

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

    Measured: 7 months

  2. Quality of Life assessment

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

    Measured: 7 months

  3. Daily functioning assessment

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

    Measured: 7 months

  4. Body Mass Index (BMI)

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

    Measured: 7 months

  5. Diffusion Tensor Imaging (DTI)

    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

    Measured: 4 months

  6. Waist circumference

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

    Measured: 7 months

  7. Blood pressure

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

    Measured: 7 months

  8. Metabolic indices

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

    Measured: 7 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2025
  2. Study start10 Jan 2019
  3. Primary completion2 Sep 2023
  4. Study completion2 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
All patients will be randomized in a 1:1:1 ratio to three parallel treatment arms: experimental intervention (CR + AE) and two active comparison arms (CR and AE)
Masking
Single blind
Who is masked
Investigator
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06810362
Sponsor's protocol ID
GR-2016-02361538
Acronym
C-CARE
Status last verified
Jan 2025
First submitted
9 Jan 2025
Last updated
5 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Heinrichs DW, Hanlon TE, Carpenter WT Jr. The Quality of Life Scale: an instrument for rating the schizophrenic deficit syndrome. Schizophr Bull. 1984;10(3):388-98. doi: 10.1093/schbul/10.3.388.

    PubMed 6474101

  • Mausbach BT, Harvey PD, Goldman SR, Jeste DV, Patterson TL. Development of a brief scale of everyday functioning in persons with serious mental illness. Schizophr Bull. 2007 Nov;33(6):1364-72. doi: 10.1093/schbul/sbm014. Epub 2007 Mar 6.

    PubMed 17341468

  • Kay SR, Fiszbein A, Opler LA. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull. 1987;13(2):261-76. doi: 10.1093/schbul/13.2.261.

    PubMed 3616518

  • Nuechterlein KH, Green MF, Kern RS, Baade LE, Barch DM, Cohen JD, Essock S, Fenton WS, Frese FJ 3rd, Gold JM, Goldberg T, Heaton RK, Keefe RS, Kraemer H, Mesholam-Gately R, Seidman LJ, Stover E, Weinberger DR, Young AS, Zalcman S, Marder SR. The MATRICS Consensus Cognitive Battery, part 1: test selection, reliability, and validity. Am J Psychiatry. 2008 Feb;165(2):203-13. doi: 10.1176/appi.ajp.2007.07010042. Epub 2008 Jan 2.

    PubMed 18172019

  • Cavallaro R, Anselmetti S, Poletti S, Bechi M, Ermoli E, Cocchi F, Stratta P, Vita A, Rossi A, Smeraldi E. Computer-aided neurocognitive remediation as an enhancing strategy for schizophrenia rehabilitation. Psychiatry Res. 2009 Oct 30;169(3):191-6. doi: 10.1016/j.psychres.2008.06.027. Epub 2009 Sep 9.

    PubMed 19740550

  • Cassilhas RC, Tufik S, de Mello MT. Physical exercise, neuroplasticity, spatial learning and memory. Cell Mol Life Sci. 2016 Mar;73(5):975-83. doi: 10.1007/s00018-015-2102-0. Epub 2015 Dec 8.

    PubMed 26646070

  • Firth J, Cotter J, Elliott R, French P, Yung AR. A systematic review and meta-analysis of exercise interventions in schizophrenia patients. Psychol Med. 2015 May;45(7):1343-61. doi: 10.1017/S0033291714003110. Epub 2015 Feb 4.

    PubMed 25650668

  • Bryce S, Sloan E, Lee S, Ponsford J, Rossell S. Cognitive remediation in schizophrenia: A methodological appraisal of systematic reviews and meta-analyses. J Psychiatr Res. 2016 Apr;75:91-106. doi: 10.1016/j.jpsychires.2016.01.004. Epub 2016 Jan 5.

    PubMed 26828372

  • Laursen TM, Munk-Olsen T, Vestergaard M. Life expectancy and cardiovascular mortality in persons with schizophrenia. Curr Opin Psychiatry. 2012 Mar;25(2):83-8. doi: 10.1097/YCO.0b013e32835035ca.

    PubMed 22249081

  • Bowie CR, Reichenberg A, Patterson TL, Heaton RK, Harvey PD. Determinants of real-world functional performance in schizophrenia subjects: correlations with cognition, functional capacity, and symptoms. Am J Psychiatry. 2006 Mar;163(3):418-25. doi: 10.1176/appi.ajp.163.3.418.

    PubMed 16513862

  • Malchow B, Keeser D, Keller K, Hasan A, Rauchmann BS, Kimura H, Schneider-Axmann T, Dechent P, Gruber O, Ertl-Wagner B, Honer WG, Hillmer-Vogel U, Schmitt A, Wobrock T, Niklas A, Falkai P. Effects of endurance training on brain structures in chronic schizophrenia patients and healthy controls. Schizophr Res. 2016 Jun;173(3):182-191. doi: 10.1016/j.schres.2015.01.005. Epub 2015 Jan 23.

    PubMed 25623601

  • Penades R, Pujol N, Catalan R, Massana G, Rametti G, Garcia-Rizo C, Bargallo N, Gasto C, Bernardo M, Junque C. Brain effects of cognitive remediation therapy in schizophrenia: a structural and functional neuroimaging study. Biol Psychiatry. 2013 May 15;73(10):1015-23. doi: 10.1016/j.biopsych.2013.01.017. Epub 2013 Feb 26.

    PubMed 23452665

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Remediation (CR), Aerobic Exercise and Cognitve Remediation + Aerobic Exercise in people with Schizophrenia and Psychosis, run by IRCCS San Raffaele at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cognitive performance (time frame: 7 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06810362, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.

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