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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
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
New York State Psychiatric Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Schizophrenia Behavioral: Aerobic Exercise Other: Standard Psychiatric Treatment Not Applicable

Detailed Description:
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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
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)




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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).


Secondary Outcome Measures :
  1. 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).



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
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United States, New York
Columbia University & New York State Psyciatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: David Kimhy, Ph.D. Columbia University & New York State Psyciatric Institute
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01897064    
Other Study ID Numbers: 6508
R21 096132 ( Other Grant/Funding Number: NIMH )
First Posted: July 11, 2013    Key Record Dates
Last Update Posted: August 15, 2014
Last Verified: August 2014
Keywords provided by New York State Psychiatric Institute:
Schizophrenia
Cognition
Aerobic Exercise
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders