An interventional study of Aerobic Exercise and Standard Psychiatric Treatment in Schizophrenia, sponsored by New York State Psychiatric Institute. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2014-08-15.
Sponsored by New York State Psychiatric Institute · Not applicable, Interventional, and Treatment
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.
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.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 41 is below the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →New York State Psychiatric Institute is the lead sponsor of 425 studies on the registry; 26 are open to participants now.
Of its 50 completed or terminated interventional studies of FDA-regulated products, 45 (90%) have results posted.
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Exclusion Criteria:
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
12 weeks of standard psychiatric treatment.
Other: Standard Psychiatric Treatment
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.
Also known as: AE
Standard psychiatric treatment.
Also known as: Treatment As Usual (TAU)
Change from Baseline in MATRICS Consensus Cognitive Battery scores at 12 weeks
Standardized battery designed to measure cognition specifically in individuals in schizophrenia.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: Baseline and after 12 weeks
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).
Time frame: Baseline and after 12 weeks
This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.
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New York State Psychiatric Institute