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| ID | Type | Description | Link |
|---|---|---|---|
| R21 096132 | Other Grant/Funding Number | NIMH |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aerobic Exercise | Experimental | 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. |
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| Standard Psychiatric Treatment | Active Comparator | 12 weeks of standard psychiatric treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aerobic Exercise | Behavioral | 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. |
| 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 |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Kimhy, Ph.D. | Columbia University & New York State Psyciatric Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University & New York State Psyciatric Institute | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26423100 | Derived | Kimhy D, Khan S, Ayanrouh L, Chang RW, Hansen MC, Lister A, Ballon JS, Vakhrusheva J, Armstrong HF, Bartels MN, Sloan RP. Use of Active-Play Video Games to Enhance Aerobic Fitness in Schizophrenia: Feasibility, Safety, and Adherence. Psychiatr Serv. 2016 Feb;67(2):240-3. doi: 10.1176/appi.ps.201400523. Epub 2015 Oct 1. |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Standard Psychiatric Treatment | Other | Standard psychiatric treatment. |
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| Baseline and after 12 weeks |