Cognitive Remediation Plus Aerobic Exercise in Schizophrenia Treatment

NCT ID: NCT02864576

Last Updated: 2022-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2020-12-31

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Cognitive Remediation_Aerobic Exercise

Intervention Type: BEHAVIORAL

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.

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.

Group Type: ACTIVE_COMPARATOR

Cognitive Remediation_Health Promotion

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Cognitive Remediation_Control Activity

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.

• Minimum Eligible Age: 28 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Parc de Salut Mar

OTHER

Sponsor Role: lead

Responsible Party

Nuria Pujol

Clinical Psychologist, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Núria Pujol, PhD

Role: PRINCIPAL_INVESTIGATOR

Parc de Salut Mar, Barcelona, Spain

Anna Mané, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Parc de Salut Mar, Barcelona, Spain

Locations

Hospital del Mar

Barcelona, , Spain

Countries

Spain

Other Identifiers

PI15/00453

Identifier Type: -

Identifier Source: org_study_id