Brain Image Markers Associated With Cognitive Training and Aerobic Exercise in Schizophrenia

NCT03509597 | Unknown DMC

• 2 other identifiers: CORTEX-SP StudyPI16/01022
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the brain correlates of Cognitive Training and Aerobic Exercise in schizophrenia. A third of participants will receive Cognitive Training plus Standard Care for schizophrenia. Another third of participants will receive Aerobic Exercise Training plus Standard Care for schizophrenia. A control group will of participants will receive Standard Care plus Occupational Activities for the same duration and frequency as the experimental groups.

Conditions

Schizophrenia

Keywords

Cognitive remediation; Aerobic exercise; Physical exercise; Negative symptoms; Functional outcome; Cognition

Outcome Measures

Primary Outcomes (4)

• Grey Matter Volume Change

  Assessment of Grey Matter volume changes (T1-weighted MRI) among the 3 groups using Voxel Based Morphometry (VBM).

  5 months

• Fractional Anisotropy Change

  Assessment of changes in fractional anisotropy of White Matter fibers by Diffusion Tensor MR Imaging and using the Tract-Based Spatial Statistics (TBSS).

  5 months

• Functional Magnetic Resonance Imaging (fMRI) Change at Rest

  Assessment of changes in fMRI at rest with the Coon Functional Connectivity Toolbox.

  5 months

• Functional Magnetic Resonance Imaging (fMRI) Change during the performance of a cognitive paradigm.

  Assessment of changes in fMRI during the performance of a cognitive paradigm with Statistical Parametric Mapping (SPM8).

  5 months

Secondary Outcomes (37)

• Serum BDNF

  5 months.

• Clinical Symptoms of Schizophrenia measured by the Positive and Negative Symptoms Scale (PANSS).

  5 months.

• Negative Symptoms of Schizophrenia measured by the Brief Negative Symptoms Scale (BNSS).

  5 months

• Negative Symptoms of Schizophrenia measured by the Clinical Assessment Interview for Negative Symptoms Scale (CAINS)

  5 months

• Functional Outcome measured by the UCSD Performance Based Assessment of Functional Skills in Severe Mental Illness (UPSA).

  5 months

Study Arms (3)

Aerobic Exercise

EXPERIMENTAL

This program consists of an exercise dosage of 180 min/week administered in 3 sessions of 60 minutes. Each session includes 10 minutes of warm-up exercise before the main exercise and 10 minutes of cool-down afterwards.the principal exercise section includes 20 minutes of aerobic exercise and 20 minutes of resistance and strength exercises. The exercise intensity will be regulated according to the heart rate measured by a pulsimeter throughout the exercise. The target intensity level will be individualized according to the heart rate to set the moderate intensity level (HR values between ventilatory thresholds) and high intensity level (HR values from 2nd. ventilatory threshold to the peak threshold).

Behavioral: Aerobic Exercise

Cognitive Training

EXPERIMENTAL

The CT group participates in a cognitive remediation program. This program consists of 3 sessions of 60 minutes per week. CT will be administered in groups of 5-8 subjects. The cognitive domains involved in the CT are attention/concentration, memory/learning, language, executive functions, social cognition, social skills, daily living activities and psychoeducation. Cognitive Remediation will be provided by using REHACOP, a cognitive remediation training tool designed and validated for Spanish patients with schizophrenia.

Behavioral: Cognitive Training

Treatment as usual

SHAM COMPARATOR

The TaU Group receives the usual treatment that patients with schizophrenia in Spain enriched with occupational activities administered 3 times a week with a duration of 60 minutes each session.

Behavioral: Treatment as usual; Behavioral: Occupational Activities

Interventions

Aerobic Exercise BEHAVIORAL

Physical exercise training consisting of aerobic exercise and strength/resistance training.

Aerobic Exercise

Cognitive Training BEHAVIORAL

Cognitive remediation program using REHACOP rehabilitation program.

Cognitive Training

Treatment as usual BEHAVIORAL

Standard care for schizophrenia + Leisure and free time activities.

Treatment as usual

Occupational Activities BEHAVIORAL

Engagement in activities aimed to keep patients actively involved in demanding tasks.

Treatment as usual

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Schizophrenia (DSM-5 F20.9)
• More than 2 years since the onset of the disease.
• Stable cognitive impairment.
• Moderate severity of cognitive impairment in MATRICS scores (T score \< 40 in, at least, 1 out of 7 cognitive domains).

You may not qualify if:

• Subjects clinically unstable (PANSS positive score \> 19).
• Cognitive impairment due to another medical condition (neurocognitive disorders, brain injury, intellectual disability, etc.)

Sponsors & Collaborators

• Red Salud Mental Araba: lead
• University of Deusto: collaborator
• University of the Basque Country (UPV/EHU): collaborator

Study Sites (1)

Hospital Psiquiatrico de Alava. Red Salud Mental de Araba

Vitoria-Gasteiz, Alava, 01006, Spain

RECRUITING

Related Publications (8)

• Sanchez P, Pena J, Bengoetxea E, Ojeda N, Elizagarate E, Ezcurra J, Gutierrez M. Improvements in negative symptoms and functional outcome after a new generation cognitive remediation program: a randomized controlled trial. Schizophr Bull. 2014 May;40(3):707-15. doi: 10.1093/schbul/sbt057. Epub 2013 May 18.

  PMID: 23686130 RESULT

• Ojeda N, Pena J, Bengoetxea E, Garcia A, Sanchez P, Elizagarate E, Segarra R, Ezcurra J, Gutierrez-Fraile M, Eguiluz JI. [REHACOP: a cognitive rehabilitation programme in psychosis]. Rev Neurol. 2012 Mar 16;54(6):337-42. Spanish.

  PMID: 22403146 RESULT

• Pena J, Ibarretxe-Bilbao N, Sanchez P, Uriarte JJ, Elizagarate E, Gutierrez M, Ojeda N. Mechanisms of functional improvement through cognitive rehabilitation in schizophrenia. J Psychiatr Res. 2018 Jun;101:21-27. doi: 10.1016/j.jpsychires.2018.03.002. Epub 2018 Mar 6.

  PMID: 29525739 RESULT

• Pena J, Ibarretxe-Bilbao N, Sanchez P, Iriarte MB, Elizagarate E, Garay MA, Gutierrez M, Iribarren A, Ojeda N. Combining social cognitive treatment, cognitive remediation, and functional skills training in schizophrenia: a randomized controlled trial. NPJ Schizophr. 2016 Nov 9;2:16037. doi: 10.1038/npjschz.2016.37. eCollection 2016.

  PMID: 27868083 RESULT

• Ojeda N, Pena J, Bengoetxea E, Garcia A, Sanchez P, Elizagarate E, Segarra R, Ezcurra J, Gutierrez-Fraile M, Eguiluz JI. [Evidence of the effectiveness of cognitive rehabilitation in psychosis and schizophrenia with the REHACOP programme]. Rev Neurol. 2012 May 16;54(10):577-86. Spanish.

  PMID: 22573504 RESULT

• Ojeda N, Pena J, Sanchez P, Bengoetxea E, Elizagarate E, Ezcurra J, Gutierrez Fraile M. Efficiency of cognitive rehabilitation with REHACOP in chronic treatment resistant Hispanic patients. NeuroRehabilitation. 2012;30(1):65-74. doi: 10.3233/NRE-2011-0728.

  PMID: 22349843 RESULT

• Tous-Espelosin M, Pavon C, Elizagarate E, Sampedro A, Maldonado-Martin S. As We Were and As We Should Be, Combined Exercise Training in Adults With Schizophrenia: CORTEX-SP Study Part II. Scand J Med Sci Sports. 2024 Aug;34(8):e14707. doi: 10.1111/sms.14707.

  PMID: 39054763 DERIVED

• Tous-Espelosin M, de Azua SR, Iriarte-Yoller N, MartinezAguirre-Betolaza A, Sanchez PM, Corres P, Arratibel-Imaz I, Sampedro A, Pena J, Maldonado-Martin S. Clinical, physical, physiological, and cardiovascular risk patterns of adults with schizophrenia: CORTEX-SP study: Characterization of adults with schizophrenia. Psychiatry Res. 2021 Jan;295:113580. doi: 10.1016/j.psychres.2020.113580. Epub 2020 Nov 18.

  PMID: 33246589 DERIVED

MeSH Terms

Conditions

Schizophrenia; Motor Activity

Interventions

Exercise; Cognitive Training; Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Pedro M Sanchez Gomez, MD

  Hospital Psiquiatrico de Alava. Red de Salud Mental de Araba.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pedro M Sanchez Gomez, MD

CONTACT

+34 945006555; gomepe@mac.com

Edorta J Elizagarate Zabala, MD

CONTACT

+34 945006555; eduardojose.elizagaratezabala@osakidetza.eus

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients are trained to not comment about the type of treatment they have been assigned to with the investigator who performs the assessments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Randomized parallel assignment: Cognitive Training, Aerobic Exercise \& Treatment as usual.

Study Record Dates

• First Submitted: April 11, 2018
• First Posted: April 26, 2018
• Study Start: March 1, 2017
• Primary Completion: December 31, 2019
• Study Completion: June 1, 2020
• Last Updated: July 30, 2019

Record last verified: 2019-07

Locations

ES (1)