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Cognitive Remediation Plus Aerobic Exercise in Schizophrenia Treatment

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ClinicalTrials.gov Identifier: NCT02864576
Recruitment Status : Unknown
Verified September 2016 by Nuria Pujol, Parc de Salut Mar.
Recruitment status was:  Recruiting
First Posted : August 12, 2016
Last Update Posted : September 20, 2016
Sponsor:
Information provided by (Responsible Party):
Nuria Pujol, 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.

Condition or disease Intervention/treatment Phase
Schizophrenia Behavioral: Cognitive Remediation_Aerobic Exercise Behavioral: Cognitive Remediation_Health Promotion Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 2016
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : April 2018

Resource links provided by the National Library of Medicine


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 Name: Cognitive Remediation_Control Activity




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

Secondary Outcome Measures :
  1. Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) overall composite score [ Time Frame: 15 months ]
  2. Brain-derived neurotrophic factor (BDNF) [ Time Frame: 3 months ]


Information from the National Library of Medicine

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02864576


Contacts
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Contact: Anna Mané, MD, PhD 0034932483175 amane@parcdesalutmar.cat
Contact: Núria Pujol, PhD 0034933037350 npujol@parcdesalutmar.cat

Locations
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Spain
Hospital del Mar Recruiting
Barcelona, Spain, 08003
Contact: Anna Mané, PhD    0034932483175    amane@parcdesalutmar.cat   
Contact: Núria Pujol, PhD    0034933037350    npujol@parcdesalutmar.cat   
Sponsors and Collaborators
Parc de Salut Mar
Investigators
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Principal Investigator: Núria Pujol, PhD Parc de Salut Mar, Barcelona, Spain
Principal Investigator: Anna Mané, MD, PhD Parc de Salut Mar, Barcelona, Spain

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Responsible Party: Nuria Pujol, Clinical Psychologist, Principal Investigator, Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT02864576     History of Changes
Other Study ID Numbers: PI15/00453
First Posted: August 12, 2016    Key Record Dates
Last Update Posted: September 20, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders