Schizophrenia Clinical Trial
Official title:
The Influence of Aerobic Exercise on Cognitive Functioning in Schizophrenia.
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.
Status | Completed |
Enrollment | 41 |
Est. completion date | July 2014 |
Est. primary completion date | July 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 55 Years |
Eligibility |
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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Columbia University & New York State Psyciatric Institute | New York | New York |
Lead Sponsor | Collaborator |
---|---|
New York State Psychiatric Institute | National Institute of Mental Health (NIMH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | No |
Primary | 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 | No |
Primary | 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 | No |
Primary | 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 | No |
Secondary | 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 | No |
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