Clinical trial NCT02864576: Cognitive Remediation Plus Aerobic Exercise in Schizophrenia Treatment
Official title: Cognitive Remediation Plus Aerobic Exercise in Schizophrenia Treatment: a Randomized Controlled Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Lead sponsor: Parc de Salut Mar
Sponsor class: OTHER
First posted: 2016-08-12
Enrollment: 74
Sex: ALL
Minimum age (years): 28
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) overall composite score
timeFrame: 3 months
Secondary outcomes:
measure: Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) overall composite score
timeFrame: 15 months
measure: Brain-derived neurotrophic factor (BDNF)
timeFrame: 3 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital del Mar
Study officials:
affiliation: Parc de Salut Mar, Barcelona, Spain
name: Núria Pujol, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Parc de Salut Mar, Barcelona, Spain
name: Anna Mané, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: