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Completed

NCT Number: NCT02864576

Cognitive Remediation Plus Aerobic Exercise in Schizophrenia Treatment

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.

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Key information

Age range

28 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital del Mar

Barcelona, 08003, Spain

About this study

Cognitive remediation (CR) and physical exercise have separately shown promising results in schizophrenia cognitive improvement, despite this, the impact in improving functionality is still limited. Physical exercise increases Brain Derived Neurotrophic Factor (BDNF) levels, promoting neuronal and cognitive plasticity, which can maximize the impact of CR. The aim of this project is to study the efficacy of an intensive program (3 months) that combines CR and physical exercise by a randomized controlled trial where 74 patients with chronic schizophrenia will be randomized to two groups: 1) CR plus physical exercise; 2) CR plus control activity (health promotion). Primary outcome measures will be cognitive performance, functional outcome, negative symptoms and BDNF levels. Measures will be blindly assessed at baseline, at 3 months follow up and at 15 months follow up. The investigators expect that: i) the CR plus physical exercise will be superior to CR plus control activity in improving cognition, functional outcome, negative symptoms and in increasing BDNF levels in the short and medium term (3 and 15 months); ii) changes in BDNF levels after the CR plus physical exercise will be an adequate biomarker of the cognitive improvement obtained with this treatment.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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_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.

Other names: Cognitive Remediation_Control Activity

Primary outcomes

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

    Time frame: 3 months

Secondary outcomes

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

    Time frame: 15 months

  2. Brain-derived neurotrophic factor (BDNF)

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Parc de Salut Mar

Other

Registry information

Official study title

Cognitive Remediation Plus Aerobic Exercise in Schizophrenia Treatment: a Randomized Controlled Study.

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Aug 12, 2016
Registry last updated
Apr 20, 2022

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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