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Cognitive Remediation Plus Aerobic Exercise in Schizophrenia Treatment

Sponsor
Parc de Salut Mar (Other)
Overall Status
Completed
CT.gov ID
NCT02864576
Collaborator
(none)
74
Enrollment
1
Location
2
Arms
51
Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Cognitive Remediation_Aerobic Exercise
  • Behavioral: Cognitive Remediation_Health Promotion
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
74 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Cognitive Remediation Plus Aerobic Exercise in Schizophrenia Treatment: a Randomized Controlled Study.
Study Start Date :
Sep 1, 2016
Actual Primary Completion Date :
Dec 1, 2020
Actual Study Completion Date :
Dec 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Behavioral: Cognitive Remediation_Aerobic Exercise
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.
Active Comparator: 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.

Behavioral: Cognitive Remediation_Health Promotion
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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) overall composite score [3 months]

    Secondary Outcome Measures

    1. Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) overall composite score [15 months]

    2. Brain-derived neurotrophic factor (BDNF) [3 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    28 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital del Mar Barcelona Spain 08003

    Sponsors and Collaborators

    • Parc de Salut Mar

    Investigators

    • Principal Investigator: Núria Pujol, PhD, Parc de Salut Mar, Barcelona, Spain
    • Principal Investigator: Anna Mané, MD, PhD, Parc de Salut Mar, Barcelona, Spain

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nuria Pujol, Clinical Psychologist, Principal Investigator, Parc de Salut Mar
    ClinicalTrials.gov Identifier:
    NCT02864576
    Other Study ID Numbers:
    • PI15/00453
    First Posted:
    Aug 12, 2016
    Last Update Posted:
    Apr 20, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Schizophrenia

    Study Results

    No Results Posted as of Apr 20, 2022