Cognitive Remediation Plus Aerobic Exercise in Schizophrenia Treatment

NCT02864576 | Completed

• 1 other identifier: PI15/00453
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

Cognitive remediation (CR) and aerobic exercise have separately shown promising results in schizophrenia cognitive improvement, despite this, the impact in improving functionality is still limited. Aerobic exercise increases Brain Derived Neurotrophic Factor (BDNF) levels, promoting neuronal and cognitive plasticity, which can maximize the impacts of CR. The aim of this randomized controlled trial is to study the efficacy of a 3-month intensive program that combines CR plus physical exercise comparing it to cognitive remediation plus a control activity.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) overall composite score

  3 months

Secondary Outcomes (2)

• Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) overall composite score

  15 months

• Brain-derived neurotrophic factor (BDNF)

  3 months

Study Arms (2)

Cognitive Remediation_Aerobic Exercise

EXPERIMENTAL

Cognitive Remediation: 12 weeks of systematic cognitive training (REHACOP), performed 3 days per week in a 90-minutes-long sessions. Aerobic Exercise: 12 weeks of systematic aerobic exercise program, performed 3 days per week, lasting 40 minutes.

Behavioral: Cognitive Remediation_Aerobic Exercise

Cognitive Remediation_Health Promotion

ACTIVE COMPARATOR

Cognitive Remediation: 12 weeks of systematic cognitive training (REHACOP), performed 3 days per week in a 90-minutes-long sessions. Health Promotion: 12 weeks of health promotion sessions, performed 3 days per week, lasting 40 minutes each.

Behavioral: Cognitive Remediation_Health Promotion

Interventions

Cognitive Remediation_Aerobic Exercise BEHAVIORAL

Cognitive Remediation: The REHACOP program consists of: Attention unit training sustained, selective, alternant and divided attention; Memory unit focusing on visual and verbal learning, recall and recognizing memory; Language unit including grammar, syntax, vocabulary, verbal fluency, verbal comprehension, abstract language; Executive functions unit training cognitive planning, proverbs, analogies; and Social cognition unit exercising theory of mind, social reasoning and moral dilemmas. Aerobic Exercise: 12 weeks of systematic aerobic exercise program. Patients will walk with a moderate intensity 10 minutes the first week and will increase gradually up to 30 minutes-walk with a moderate intensity. Patients will also perform 5 minutes of warm-up and stretching.

Cognitive Remediation_Aerobic Exercise

Cognitive Remediation_Health Promotion BEHAVIORAL

Cognitive Remediation: The REHACOP program consists of: Attention unit training sustained, selective, alternant and divided attention; Memory unit focusing on visual and verbal learning, recall and recognizing memory; Language unit including grammar, syntax, vocabulary, verbal fluency, verbal comprehension, abstract language; Executive functions unit training cognitive planning, proverbs, analogies; and Social cognition unit exercising theory of mind, social reasoning and moral dilemmas. Health Promotion: 12 weeks of health promotion sessions. These sessions will be carried out by a specialized/trained nurse.

Also known as: Cognitive Remediation_Control Activity

Cognitive Remediation_Health Promotion

Eligibility Criteria

• Age: 28 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• A diagnosis by Diagnostic and Statistical Manual of Mental Disorders of schizophrenia or schizoaffective disorder with a minimum of 10 years illness evolution/duration;
• Between 28 and 60 years of age;
• Clinically stable (no changes in psychotropic medication in the previous months, except for benzodiazepines)
• Sufficient acculturation and fluency in the Spanish language to avoid invalidating research measures of thought, language, and speech disorder or of verbal cognitive abilities;
• Low physical activity, as measured by International Physical Activity Questionnaire, IPAQ;
• Signed informed consent

You may not qualify if:

• Evidence of a known neurological disorder (e.g., epilepsy) or significant head injury;
• Evidence of substance use disorder within the previous 3 months;
• mental retardation, i.e. premorbid intelligence quotient less than 70;
• Electroconvulsive therapy in previous 6 months.
• Somatic illnesses that contraindicate physical exercise.

Sponsors & Collaborators

• Parc de Salut Mar: lead

Study Sites (1)

Hospital del Mar

Barcelona, 08003, Spain

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Núria Pujol, PhD

  Parc de Salut Mar, Barcelona, Spain

  PRINCIPAL INVESTIGATOR

• Anna Mané, MD, PhD

  Parc de Salut Mar, Barcelona, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Psychologist, Principal Investigator

Study Record Dates

• First Submitted: July 26, 2016
• First Posted: August 12, 2016
• Study Start: September 1, 2016
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: April 20, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)