Schizophrenia Clinical Trial
Official title:
Cognitive Remediation Plus Aerobic Exercise in Schizophrenia Treatment: a Randomized Controlled Study.
NCT number | NCT02864576 |
Other study ID # | PI15/00453 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 2016 |
Est. completion date | December 2020 |
Verified date | April 2022 |
Source | Parc de Salut Mar |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 74 |
Est. completion date | December 2020 |
Est. primary completion date | December 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 28 Years to 60 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital del Mar | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Parc de Salut Mar |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) overall composite score | 3 months | ||
Secondary | Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) overall composite score | 15 months | ||
Secondary | Brain-derived neurotrophic factor (BDNF) | 3 months |
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