SchizophreniaNCT02864576
Cognitive Remediation Plus Aerobic Exercise in Schizophrenia Treatment
A study testing Cognitive Remediation_Aerobic Exercise and Cognitive Remediation_Health Promotion in people with Schizophrenia, run by Parc de Salut Mar at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 28 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Cognitive Remediation_Aerobic Exercise and Cognitive Remediation_Health Promotion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2016to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- A diagnosis by Diagnostic and Statistical Manual of Mental Disorders of schizophrenia or schizoaffective disorder with a minimum of 10 years illness evolution/duration;
- Between 28 and 60 years of age;
- Clinically stable (no changes in psychotropic medication in the previous months, except for benzodiazepines)
- Sufficient acculturation and fluency in the Spanish language to avoid invalidating research measures of thought, language, and speech disorder or of verbal cognitive abilities;
- Low physical activity, as measured by International Physical Activity Questionnaire, IPAQ;
- Signed informed consent
Who cannot join
- Evidence of a known neurological disorder (e.g., epilepsy) or significant head injury;
- Evidence of substance use disorder within the previous 3 months;
- mental retardation, i.e. premorbid intelligence quotient less than 70;
- Electroconvulsive therapy in previous 6 months.
- Somatic illnesses that contraindicate physical exercise.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cognitive Remediation Plus Aerobic Exercise in Schizophrenia Treatment: a Randomized Controlled Study.
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.
Read the 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
- Being tested
- Cognitive Remediation_Aerobic Exercise, Cognitive Remediation_Health Promotion
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Remediation_Aerobic ExerciseBehavioural
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 PromotionBehavioural
Also called Cognitive Remediation_Control Activity
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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Remediation_Aerobic Exercise | Experimental | 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. Receives: Behavioral: Cognitive Remediation_Aerobic Exercise |
| Cognitive Remediation_Health Promotion | Active comparator | 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. Receives: Behavioral: Cognitive Remediation_Health Promotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) overall composite score
Measured: 3 months
Secondary outcomes (2)
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) overall composite score
Measured: 15 months
Brain-derived neurotrophic factor (BDNF)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nuria Pujol, Parc de Salut Mar
- Investigators
- Núria Pujol, PhD, Principal investigator, Parc de Salut Mar, Barcelona, SpainAnna Mané, MD, PhD, Principal investigator, Parc de Salut Mar, Barcelona, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02864576
- Sponsor's protocol ID
- PI15/00453
- Status last verified
- Apr 2022
- First submitted
- 26 Jul 2016
- Last updated
- 20 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Remediation Plus Aerobic Exercise in Schizophrenia Treatment: a Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT02864576
- Acronym / sponsor ID
- PI15/00453
- Conditions
- Schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 12 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Remediation_Aerobic Exercise | Experimental | Behavioral: Cognitive Remediation_Aerobic ExerciseCognitive 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. |
| Cognitive Remediation_Health Promotion | Active comparator | Behavioral: Cognitive Remediation_Health PromotionCognitive 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. |
Who may qualify
- Ages
- 28 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- A diagnosis by Diagnostic and Statistical Manual of Mental Disorders of schizophrenia or schizoaffective disorder with a minimum of 10 years illness evolution/duration;
- Between 28 and 60 years of age;
- Clinically stable (no changes in psychotropic medication in the previous months, except for benzodiazepines)
- Sufficient acculturation and fluency in the Spanish language to avoid invalidating research measures of thought, language, and speech disorder or of verbal cognitive abilities;
- Low physical activity, as measured by International Physical Activity Questionnaire, IPAQ;
Key exclusion criteria (5 listed)
- Evidence of a known neurological disorder (e.g., epilepsy) or significant head injury;
- Evidence of substance use disorder within the previous 3 months;
- mental retardation, i.e. premorbid intelligence quotient less than 70;
- Electroconvulsive therapy in previous 6 months.
- Somatic illnesses that contraindicate physical exercise.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Remediation_Aerobic ExerciseCognitive 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. | Behavioural | Cognitive Remediation_Aerobic Exercise |
| Cognitive Remediation_Health PromotionAlso: Cognitive Remediation_Control ActivityCognitive 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. | Behavioural | Cognitive Remediation_Health Promotion |
Primary outcome
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) overall composite score
Time frame: 3 months
2 secondary outcomes
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) overall composite score
Time frame: 15 months
Brain-derived neurotrophic factor (BDNF)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Núria Pujol, PhD principal investigator
Parc de Salut Mar, Barcelona, Spain
Anna Mané, MD, PhD principal investigator
Parc de Salut Mar, Barcelona, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Remediation_Aerobic Exercise and Cognitive Remediation_Health Promotion in people with Schizophrenia, run by Parc de Salut Mar at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) overall composite score (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2022.