Cognitive Remediation Plus Aerobic Exercise in Schizophrenia Treatment

Not Applicable

Completed

• Conditions: Schizophrenia
• Interventions: Behavioral: Cognitive Remediation_Health Promotion; Behavioral: Cognitive Remediation_Aerobic Exercise

• Registration Number: NCT02864576
• Lead Sponsor: Parc de Salut Mar

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.

Study Timeline

• Study First Submitted: 2016-07-26
• Study First Submitted QC: 2016-08-08
• Study First Posted: 2016-08-12
• Study Start: 2016-09
• Primary Completion: 2020-12
• Study Completion: 2020-12
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-19
• Last Update Posted: 2022-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive Remediation_Health Promotion	Cognitive Remediation_Health Promotion	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.
Cognitive Remediation_Aerobic Exercise	Cognitive Remediation_Aerobic Exercise	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.

Primary Outcome Measures

Name	Time	Method
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) overall composite score	3 months

Secondary Outcome Measures

Name	Time	Method
Brain-derived neurotrophic factor (BDNF)	3 months
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) overall composite score	15 months

Trial Locations

Locations (1)

Hospital del Mar; 🇪🇸 Barcelona, Spain