Cognitive Remediation Plus Aerobic Exercise in Schizophrenia Treatment
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

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.
    

Detailed description: 
      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.
    

Intervention name(s): Cognitive Remediation_Aerobic Exercise; Cognitive Remediation_Health Promotion
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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:
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 intervention name(s): Cognitive Remediation_Control Activity
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment