The Influence of Aerobic Exercise on Cognitive Functioning in Schizophrenia.

Study Overview
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Brief Summary
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The aim of this study is to look at the effects of Aerobic Exercise (AE) on daily and neurocognitive functioning including memory, attention, the ability to plan activities, and learn new information. Participants will be assigned by chance to receive regular care or exercise sessions in addition to regular care. This study will allow determining the potential positive influence of AE on cognitive and daily functioning in individuals with schizophrenia.

Detailed Description
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Individuals with schizophrenia often display cognitive difficulties. Studies among non-clinical populations suggest that Aerobic Exercise (AE) training is effective in increasing both aerobic fitness and cognitive functioning. However, these associations have not been studied among individuals with schizophrenia, despite the presence of highly sedentary lifestyle in this population To elucidate this putative link, the present study will evaluate the influence of AE on cognitive functioning and daily functioning in individuals with schizophrenia using a single-blind, randomized clinical trial. Outpatient individuals with schizophrenia receiving treatment will be randomly assigned to AE training or Treatment As Usual (TAU). Participants in the AE training will undergo a 12-week, 3 times per week, 1-hour AE sessions. All participants will continue their regular psychiatric and medical care. Assessments of neurocognitive and daily functioning abilities, along with symptom severity, and physiological and behavioral measures of aerobic fitness will be completed before and after the 12-week program.

Official Title
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The Influence of Aerobic Exercise on Cognitive Functioning in Schizophrenia.

Conditions
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Schizophrenia

Intervention / Treatment
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* Behavioral: Aerobic Exercise
* Other: Standard Psychiatric Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females between ages 18-55. Have capacity to give informed consent. English speaking. Have a DSM-IV diagnosis of schizophrenia. Taking antipsychotic medication for at least 8 weeks and on current doses for 4 weeks, and/or injectable depot antipsychotics with no change in last 3 months. Medically cleared to exercise. Exclusion Criteria: Lacks capacity to give informed consent. Have used street drugs within the past 4 weeks. Have history of of hypertension of cardiac conditions. Have history of active suicidal ideation or serious self-destructive behavior. Have history of violence or aggressive behavior. Have history of neurological or medical conditions known to seriously affect the brain. Pregnant or nursing. Completing more than 2 hours of moderate or higher levels of aerobic exercise per week. Participation in a study of cognition during the previous 2 months.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aerobic Exercise<br>Up to 36 sessions of aerobic exercise (12 weeks of 3 times/week, 60-minute exercise sessions) in small groups (3-5 individuals), in addition to standard psychiatric treatment. | Behavioral: Aerobic Exercise<br>* 36 sessions of aerobic exercise (12 weeks of 3 times/week, 60-minute exercise sessions) in small groups (3-5 individuals), in addition to standard psychiatric care.<br>* Other names: AE;|
| Active Comparator: Standard Psychiatric Treatment<br>12 weeks of standard psychiatric treatment. | Other: Standard Psychiatric Treatment<br>* Standard psychiatric treatment.<br>* Other names: Treatment As Usual (TAU);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in MATRICS Consensus Cognitive Battery scores at 12 weeks | Standardized battery designed to measure cognition specifically in individuals in schizophrenia. | Baseline and after 12 weeks. | 
| Change from Baseline in VO2Max (maximal oxygen consumption) at 12 weeks | The VO2Max (maximal oxygen consumption) test measures maximum ability to consume oxygen and is a key indicator of aerobic fitness. | Baseline and after 12 weeks | 
| Change from Baseline in 6-Minute Walk Test (6MWT) score at 12 weeks | The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. | Baseline and after 12 weeks | 
| Change from Baseline in Daily Functioning Assessments at 12 weeks | Measures include: The Specific Levels of Functioning Scale (SLOF), Quality of Life Scale (QLS), and Quality of Life Scale (QoL-16). | Baseline and after 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in The Cognitive Neuroscience Treatment Research to Improve Cognition in Schizophrenia program (CNTRICS) measures at 12 weeks | Measures include: AX-CPT/Dot Pattern Expectancy (DPX) Task, Recent Probe Task, Relational Item Specific Encoding Task, Probabilistic Reward Task, Sustained Attention Task with and without Distraction, Automated Operation Span Task (OSPAN), and Automated Symmetry Span Task (SSPAN). | Baseline and after 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, Cognition, Aerobic Exercise