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Trial record 1 of 1 for:    NCT03270098
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Improving Cognition Via Exercise in Schizophrenia

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ClinicalTrials.gov Identifier: NCT03270098
Recruitment Status : Recruiting
First Posted : September 1, 2017
Last Update Posted : March 31, 2020
Sponsor:
Collaborators:
University of North Carolina, Chapel Hill
Stanford University
Augusta University
Columbia University
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Icahn School of Medicine at Mount Sinai

Brief Summary:
People with schizophrenia display a broad range of cognitive impairments that have been identified as major determinants of poor functioning and disability. Also, people with schizophrenia are at increased risk for suicide, with approximately 40-50% of individuals attempting to take their own lives during their lifetime. The goal of the proposed study is to examine the impact of exercise training on cognition, suicide risk, daily functioning, and biomarkers of cognitive change and suicidality in people with schizophrenia.

Condition or disease Intervention/treatment Phase
Schizophrenia and Related Disorders Behavioral: Aerobic Exercise Behavioral: Stretching and Toning Exercise Not Applicable

Detailed Description:
The goal of the proposed study is to examine the impact of exercise training on cognitive functioning in people with schizophrenia. People with schizophrenia display a broad range of cognitive impairments that have been identified as major determinants of poor functional outcome and disability, thus representing an important public health concern and a target for interventions. At present, available treatments offer only minimal to limited benefits to ameliorate these deficits. Extensive animal and human research literatures converge in supporting the positive influence of aerobic exercise training on cognitive functioning. Preliminary data indicate that aerobic exercise training is effective in improving cognitive functioning in people with schizophrenia. However, previous studies employed small samples, focused on a single or limited range of cognitive domains, and/or collected insufficient information on daily functioning or putative biomarkers underlying cognitive change. Supported by supplement funding from NIMH, the goal of the proposed study is also to explore the impact of exercise training on suicide risk in individuals with schizophrenia. People with schizophrenia are at increased risk for suicide, with approximately 40-50% of individuals attempting to take their own lives during their lifetime, and an estimated 5-10% actually being successful in completing suicide. This highly elevated risk represents a serious public health concern and an important target for interventions. However, available treatments offer only minimal to limited benefits to ameliorate this risk. Extensive animal and human research literatures converge in supporting the positive influence of AE training on a number of predictors of suicide risk including depressed mood, sleep difficulties, and poor cognition. Yet, at present there are no studies directly examining the impact of AE on suicide risk in this population.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study is a single-blind, parallel assignment, multi-site randomized clinical trial designed to examine the impact of exercise on cognition, daily functioning, and biomarkers of cognitive change in people with schizophrenia.
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Cognition Via Exercise in Schizophrenia
Actual Study Start Date : April 26, 2018
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Aerobic Exercise
using traditional exercise equipment (i.e., treadmill, stationary bike) along with active-play video games (Xbox Kinect).
Behavioral: Aerobic Exercise
Trainer-led one hour aerobic exercise sessions, three times per week, over 12 weeks.

Active Comparator: Stretching and Toning Exercise Behavioral: Stretching and Toning Exercise
Trainer-led one hour stretching-and-toning exercise sessions, three times per week, over 12 weeks.




Primary Outcome Measures :
  1. Change in the MATRICS Consensus Cognitive Battery (MCCB) [ Time Frame: Baseline and 12 weeks ]
    The MCCB is a standardized battery designed to measure cognitive functioning in people with schizophrenia. The MCCB is represented as a composite T score. Change in the MCCB at 12 weeks as compared to baseline.

  2. Change in VO2Max [ Time Frame: Baseline and 12 weeks ]
    VO2Max (maximal oxygen consumption) is an index of the ability to consume oxygen and is a key indicator of aerobic fitness. Change in the VO2Max at 12 weeks as compared to baseline.


Secondary Outcome Measures :
  1. Change in the Specific Levels of Functioning Scale (SLOF) [ Time Frame: Baseline and 12 weeks ]
    The SLOF is a 43-item survey assessing multiple domains of daily functioning. Total score range from 43 to 215, with higher scores indicating better the overall functioning. Change in the SLOF at 12 weeks as compared to baseline.

  2. Change in the UCSD Performance-based Skills Assessment (UPSA) [ Time Frame: Baseline and 12 weeks ]
    The UPSA is performance-based measure of real-world daily functioning abilities. Participants receive scores for multiple domains, which are summed to create a summary score ranging from 0 to 100 with higher score indicating better overall functioning. Change in the UPSA at 12 weeks as compared to baseline.

  3. Change in the Schizophrenia Cognition Rating Scale (SCoRS) [ Time Frame: Baseline and 12 weeks ]
    The SCoRS is a 20-item clinician-administered interview assessing cognition-related daily functioning. Each item rated on a 4-point scale ranging from "no impairment" to "severe impairment". Total scores range from 20-80, with higher score indicating poorer functioning. Change in the SCoRS at 12 weeks as compared to baseline.

  4. Serum BDNF [ Time Frame: Baseline and 12 weeks ]
    BDNF is extracted from blood samples and serves as a biomarker of exercise-related cognitive changes. Change in the BDNF at 12 weeks as compared to baseline.

  5. Change in Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Baseline and 12 weeks ]
    The C-SSRS is a semi-structured interview that measures 4 suicide risk related domains: ideation severity, ideation intensity, behavior, and lethality. Full scale from 1-10, with higher score indicating more suicidal ideation and behavior. Change in the C-SSRS at 12 weeks as compared to baseline.



Information from the National Library of Medicine

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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:

  • A DSM-V diagnosis of schizophrenia, schizoaffective, or schizophreniform disorder.
  • Age 18-55 years.
  • Taking antipsychotic medication for at least 8 weeks and on current doses for 4 weeks, and/or injectable depot antipsychotics with no change in the last 3 months.
  • Capacity to understand all the potential risks and benefits of the study.
  • Medically cleared by a physician to take part in VO2max tests and aerobic exercise training or stretching-and-toning exercise training.

Exclusion Criteria:

  • A DSM-V diagnosis of alcohol/substance abuse (except nicotine) within the last month or a diagnosis of alcohol/substance dependence (except nicotine) within the last 6 months
  • Initiation of anti-depressants, mood stabilizers, or other medications known to impact cognition in previous 4 weeks or any change in doses during this period.
  • History of seizures/head trauma with loss of consciousness (>10 minutes) resulting in cognitive sequelae.
  • Significant clinical abnormalities in physical examination, lab assessments, or ECG.
  • Neurological/medical conditions that could interfere with study participation (e.g., unstable cardiac disease, stuttering).
  • Body Mass Index (BMI) ≥ 40.
  • Untreated hyper- or hypothyroidism.
  • Being pregnant or nursing.
  • Serious homicidal/suicidal risk (past 6 months).
  • "Moderate" or more severe conceptual disorganization (PANSS≥4).
  • Poor English reading ability (WTAR<7).
  • Participation in a study with cognitive assessment in the past 3 months.
  • Serious homicidal risk (past 6 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): NCT03270098


Contacts
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Contact: David Kimhy, PhD 212-585-4656 david.kimhy@mssm.edu

Locations
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United States, California
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Lauren Chang    650-498-8459    laurensc@stanford.edu   
Contact: Daniel Virtheim    (650) 353-7030    dmvirt@stanford.edu   
Principal Investigator: Jacob Ballon, MD, MPH         
United States, Georgia
Augusta University Recruiting
Augusta, Georgia, United States, 30912
Contact: Rebecca Nichols    706-721-4605    RNichols@augusta.edu   
Principal Investigator: Joseph McEvoy, MD         
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Luz Ospina, PhD    212-585-4647    luz.ospina@mssm.edu   
Principal Investigator: David Kimhy, PhD         
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Terry Edwards    919-445-0271    teresa_edwards@med.unc.edu   
Principal Investigator: Fred Jarskog, MD         
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
University of North Carolina, Chapel Hill
Stanford University
Augusta University
Columbia University
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: David Kimhy, PhD Icahn School of Medicine at Mount Sinai
Principal Investigator: T. Scott Stroup, MD, MPH Columbia University
Publications:

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Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT03270098    
Other Study ID Numbers: GCO 17-1511
1R01MH110623-01A1 ( U.S. NIH Grant/Contract )
3R01MH110623-03S1 ( U.S. NIH Grant/Contract )
First Posted: September 1, 2017    Key Record Dates
Last Update Posted: March 31, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Icahn School of Medicine at Mount Sinai:
Schizophrenia
Aerobic Exercise
Cognition
Daily Functioning
Biomarkers
Brain Derived Neurotrophic Factor
Suicide Risk
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders