The Influence of Aerobic Exercise on Cognitive Functioning in Schizophrenia.
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|ClinicalTrials.gov Identifier: NCT01897064|
Recruitment Status : Completed
First Posted : July 11, 2013
Last Update Posted : August 15, 2014
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Behavioral: Aerobic Exercise Other: Standard Psychiatric Treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||The Influence of Aerobic Exercise on Cognitive Functioning in Schizophrenia.|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2014|
Experimental: Aerobic Exercise
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
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.
Other Name: AE
Active Comparator: Standard Psychiatric Treatment
12 weeks of standard psychiatric treatment.
Other: Standard Psychiatric Treatment
Standard psychiatric treatment.
Other Name: Treatment As Usual (TAU)
- Change from Baseline in MATRICS Consensus Cognitive Battery scores at 12 weeks [ Time Frame: Baseline and after 12 weeks. ]Standardized battery designed to measure cognition specifically in individuals in schizophrenia.
- Change from Baseline in VO2Max (maximal oxygen consumption) at 12 weeks [ Time Frame: Baseline and after 12 weeks ]The VO2Max (maximal oxygen consumption) test measures maximum ability to consume oxygen and is a key indicator of aerobic fitness.
- Change from Baseline in 6-Minute Walk Test (6MWT) score at 12 weeks [ Time Frame: Baseline and after 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.
- Change from Baseline in Daily Functioning Assessments at 12 weeks [ Time Frame: Baseline and after 12 weeks ]Measures include: The Specific Levels of Functioning Scale (SLOF), Quality of Life Scale (QLS), and Quality of Life Scale (QoL-16).
- Change from Baseline in The Cognitive Neuroscience Treatment Research to Improve Cognition in Schizophrenia program (CNTRICS) measures at 12 weeks [ Time Frame: Baseline and after 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01897064
|United States, New York|
|Columbia University & New York State Psyciatric Institute|
|New York, New York, United States, 10032|
|Principal Investigator:||David Kimhy, Ph.D.||Columbia University & New York State Psyciatric Institute|