<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03270098</url>
  </required_header>
  <id_info>
    <org_study_id>GCO 17-1511</org_study_id>
    <secondary_id>1R01MH110623-01A1</secondary_id>
    <secondary_id>3R01MH110623-03S1</secondary_id>
    <nct_id>NCT03270098</nct_id>
  </id_info>
  <brief_title>Improving Cognition Via Exercise in Schizophrenia</brief_title>
  <official_title>Improving Cognition Via Exercise in Schizophrenia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Icahn School of Medicine at Mount Sinai</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Augusta University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Columbia University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Icahn School of Medicine at Mount Sinai</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      People with schizophrenia display a broad range of cognitive impairments that have been&#xD;
      identified as major determinants of poor functioning and disability. Also, people with&#xD;
      schizophrenia are at increased risk for suicide, with approximately 40-50% of individuals&#xD;
      attempting to take their own lives during their lifetime. The goal of the proposed study is&#xD;
      to examine the impact of remote exercise training on cognition, suicide risk, daily&#xD;
      functioning, and biomarkers of cognitive change and suicidality in people with schizophrenia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of the proposed study is to examine the impact of remote exercise training on&#xD;
      cognitive functioning in people with schizophrenia. People with schizophrenia display a broad&#xD;
      range of cognitive impairments that have been identified as major determinants of poor&#xD;
      functional outcome and disability, thus representing an important public health concern and a&#xD;
      target for interventions. At present, available treatments offer only minimal to limited&#xD;
      benefits to ameliorate these deficits. Extensive animal and human research literatures&#xD;
      converge in supporting the positive influence of aerobic exercise training on cognitive&#xD;
      functioning. Preliminary data indicate that aerobic exercise training is effective in&#xD;
      improving cognitive functioning in people with schizophrenia. However, previous studies&#xD;
      employed small samples, focused on a single or limited range of cognitive domains, and/or&#xD;
      collected insufficient information on daily functioning or putative biomarkers underlying&#xD;
      cognitive change. Supported by supplement funding from NIMH, the goal of the proposed study&#xD;
      is also to explore the impact of remote exercise training on suicide risk in individuals with&#xD;
      schizophrenia. People with schizophrenia are at increased risk for suicide, with&#xD;
      approximately 40-50% of individuals attempting to take their own lives during their lifetime,&#xD;
      and an estimated 5-10% actually being successful in completing suicide. This highly elevated&#xD;
      risk represents a serious public health concern and an important target for interventions.&#xD;
      However, available treatments offer only minimal to limited benefits to ameliorate this risk.&#xD;
      Extensive animal and human research literatures converge in supporting the positive influence&#xD;
      of AE training on a number of predictors of suicide risk including depressed mood, sleep&#xD;
      difficulties, and poor cognition. Yet, at present there are no studies directly examining the&#xD;
      impact of AE on suicide risk in this population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 26, 2018</start_date>
  <completion_date type="Actual">January 31, 2023</completion_date>
  <primary_completion_date type="Actual">January 31, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <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.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the MATRICS Consensus Cognitive Battery (MCCB)</measure>
    <time_frame>Baseline and 12 weeks</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in VO2Max</measure>
    <time_frame>Baseline and 12 weeks</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in the Specific Levels of Functioning Scale (SLOF)</measure>
    <time_frame>Baseline and 12 weeks</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the UCSD Performance-based Skills Assessment (UPSA)</measure>
    <time_frame>Baseline and 12 weeks</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Schizophrenia Cognition Rating Scale (SCoRS)</measure>
    <time_frame>Baseline and 12 weeks</time_frame>
    <description>The SCoRS is a 20-item clinician-administered interview assessing cognition-related daily functioning. Each item rated on a 4-point scale ranging from &quot;no impairment&quot; to &quot;severe impairment&quot;. Total scores range from 20-80, with higher score indicating poorer functioning. Change in the SCoRS at 12 weeks as compared to baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum BDNF</measure>
    <time_frame>Baseline and 12 weeks</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Columbia Suicide Severity Rating Scale (C-SSRS)</measure>
    <time_frame>Baseline and 12 weeks</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">104</enrollment>
  <condition>Schizophrenia and Related Disorders</condition>
  <arm_group>
    <arm_group_label>Aerobic Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Using trainer-led video calls with traditional callisthenic body movements (e.g., jumping jacks, burpees, etc.)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stretching and Toning Exercise</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Using trainer-led video calls with stretching and toning exercises.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Aerobic Exercise</intervention_name>
    <description>Trainer-led one hour aerobic exercise sessions, three times per week, over 12 weeks.</description>
    <arm_group_label>Aerobic Exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Stretching and Toning Exercise</intervention_name>
    <description>Trainer-led one hour stretching-and-toning exercise sessions, three times per week, over 12 weeks.</description>
    <arm_group_label>Stretching and Toning Exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A DSM-V diagnosis of schizophrenia, schizoaffective, or schizophreniform disorder.&#xD;
&#xD;
          -  Age 18-55 years.&#xD;
&#xD;
          -  Taking antipsychotic medication for at least 8 weeks and on current doses for 4 weeks,&#xD;
             and/or injectable depot antipsychotics with no change in the last 3 months.&#xD;
&#xD;
          -  Capacity to understand all the potential risks and benefits of the study.&#xD;
&#xD;
          -  Medically cleared by a physician to take part in VO2max tests and aerobic exercise&#xD;
             training or stretching-and-toning exercise training.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A DSM-V diagnosis of alcohol/substance abuse (except nicotine) within the last month&#xD;
             or a diagnosis of alcohol/substance dependence (except nicotine) within the last 6&#xD;
             months&#xD;
&#xD;
          -  Initiation of anti-depressants, mood stabilizers, or other medications known to impact&#xD;
             cognition in previous 4 weeks or any change in doses during this period.&#xD;
&#xD;
          -  History of seizures/head trauma with loss of consciousness (&gt;10 minutes) resulting in&#xD;
             cognitive sequelae.&#xD;
&#xD;
          -  Significant clinical abnormalities in physical examination, lab assessments, or ECG.&#xD;
&#xD;
          -  Neurological/medical conditions that could interfere with study participation (e.g.,&#xD;
             unstable cardiac disease, stuttering).&#xD;
&#xD;
          -  Body Mass Index (BMI) ≥ 40.&#xD;
&#xD;
          -  Untreated hyper- or hypothyroidism.&#xD;
&#xD;
          -  Being pregnant or nursing.&#xD;
&#xD;
          -  Serious homicidal/suicidal risk (past 6 months).&#xD;
&#xD;
          -  &quot;Moderate&quot; or more severe conceptual disorganization (PANSS≥4).&#xD;
&#xD;
          -  Poor English reading ability (WTAR&lt;7).&#xD;
&#xD;
          -  Participation in a study with cognitive assessment in the past 3 months.&#xD;
&#xD;
          -  Serious homicidal risk (past 6 months)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Kimhy, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Icahn School of Medicine at Mount Sinai</affiliation>
  </overall_official>
  <overall_official>
    <last_name>T. Scott Stroup, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Columbia University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Stanford University</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Augusta University</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Icahn School of Medicine at Mount Sinai</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of North Carolina</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Kimhy D, Vakhrusheva J, Bartels MN, Armstrong HF, Ballon JS, Khan S, Chang RW, Hansen MC, Ayanruoh L, Lister A, Castren E, Smith EE, Sloan RP. The Impact of Aerobic Exercise on Brain-Derived Neurotrophic Factor and Neurocognition in Individuals With Schizophrenia: A Single-Blind, Randomized Clinical Trial. Schizophr Bull. 2015 Jul;41(4):859-68. doi: 10.1093/schbul/sbv022. Epub 2015 Mar 23.</citation>
    <PMID>25805886</PMID>
  </reference>
  <reference>
    <citation>Kimhy D, Lauriola V, Bartels MN, Armstrong HF, Vakhrusheva J, Ballon JS, Sloan RP. Aerobic exercise for cognitive deficits in schizophrenia - The impact of frequency, duration, and fidelity with target training intensity. Schizophr Res. 2016 Apr;172(1-3):213-5. doi: 10.1016/j.schres.2016.01.055. Epub 2016 Feb 3. No abstract available.</citation>
    <PMID>26852401</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>26423100</PMID>
  </reference>
  <reference>
    <citation>Armstrong HF, Bartels MN, Paslavski O, Cain D, Shoval HA, Ballon JS, Khan S, Sloan RP, Kimhy D. The impact of aerobic exercise training on cardiopulmonary functioning in individuals with schizophrenia. Schizophr Res. 2016 May;173(1-2):116-7. doi: 10.1016/j.schres.2016.03.009. Epub 2016 Mar 11. No abstract available.</citation>
    <PMID>26976498</PMID>
  </reference>
  <reference>
    <citation>Vakhrusheva J, Marino B, Stroup TS, Kimhy D. Aerobic Exercise in People with Schizophrenia: Neural and Neurocognitive Benefits. Curr Behav Neurosci Rep. 2016 Jun;3(2):165-175. doi: 10.1007/s40473-016-0077-2. Epub 2016 Apr 4.</citation>
    <PMID>27766192</PMID>
  </reference>
  <reference>
    <citation>Kimhy D, Vakhrusheva J, Bartels MN, Armstrong HF, Ballon JS, Khan S, Chang RW, Hansen MC, Ayanruoh L, Smith EE, Sloan RP. Aerobic fitness and body mass index in individuals with schizophrenia: Implications for neurocognition and daily functioning. Psychiatry Res. 2014 Dec 30;220(3):784-91. doi: 10.1016/j.psychres.2014.08.052. Epub 2014 Sep 3.</citation>
    <PMID>25219618</PMID>
  </reference>
  <reference>
    <citation>Ospina LH, Wall M, Jarskog LF, Ballon JS, McEvoy J, Bartels MN, Buchsbaum R, Sloan RP, Stroup TS, Kimhy D. Improving Cognition via Exercise (ICE): Study Protocol for a Multi-Site, Parallel-Group, Single-Blind, Randomized Clinical Trial Examining the Efficacy of Aerobic Exercise to Improve Neurocognition, Daily Functioning, and Biomarkers of Cognitive Change in Individuals with Schizophrenia. J Psychiatr Brain Sci. 2019;4:e190020. doi: 10.20900/jpbs.20190020. Epub 2019 Dec 30.</citation>
    <PMID>31938726</PMID>
  </reference>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>August 30, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>April 12, 2023</last_update_submitted>
  <last_update_submitted_qc>April 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Icahn School of Medicine at Mount Sinai</investigator_affiliation>
    <investigator_full_name>David Kimhy</investigator_full_name>
    <investigator_title>Associate Professor, Psychiatry</investigator_title>
  </responsible_party>
  <keyword>Schizophrenia</keyword>
  <keyword>Aerobic Exercise</keyword>
  <keyword>Cognition</keyword>
  <keyword>Daily Functioning</keyword>
  <keyword>Biomarkers</keyword>
  <keyword>Brain Derived Neurotrophic Factor</keyword>
  <keyword>Suicide Risk</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03270098
org study id: GCO 17-1511
secondary id: 1R01MH110623-01A1
secondary id: 3R01MH110623-03S1
nct id: NCT03270098
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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 remote exercise training on cognition, suicide risk, daily
      functioning, and biomarkers of cognitive change and suicidality in people with schizophrenia.
The goal of the proposed study is to examine the impact of remote 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 remote 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.
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.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in the MATRICS Consensus Cognitive Battery (MCCB)
time frame: Baseline and 12 weeks
description: 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.
measure: Change in VO2Max
time frame: Baseline and 12 weeks
description: 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.
measure: Change in the Specific Levels of Functioning Scale (SLOF)
time frame: Baseline and 12 weeks
description: 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.
measure: Change in the UCSD Performance-based Skills Assessment (UPSA)
time frame: Baseline and 12 weeks
description: 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.
measure: Change in the Schizophrenia Cognition Rating Scale (SCoRS)
time frame: Baseline and 12 weeks
description: 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.
measure: Serum BDNF
time frame: Baseline and 12 weeks
description: 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.
measure: Change in Columbia Suicide Severity Rating Scale (C-SSRS)
time frame: Baseline and 12 weeks
description: 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.
arm group label: Aerobic Exercise
arm group type: Experimental
description: Using trainer-led video calls with traditional callisthenic body movements (e.g., jumping jacks, burpees, etc.)
arm group label: Stretching and Toning Exercise
arm group type: Active Comparator
description: Using trainer-led video calls with stretching and toning exercises.
intervention type: Behavioral
intervention name: Aerobic Exercise
description: Trainer-led one hour aerobic exercise sessions, three times per week, over 12 weeks.
arm group label: Aerobic Exercise
intervention type: Behavioral
intervention name: Stretching and Toning Exercise
description: Trainer-led one hour stretching-and-toning exercise sessions, three times per week, over 12 weeks.
arm group label: Stretching and Toning Exercise
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: David Kimhy, PhD
role: Principal Investigator
affiliation: Icahn School of Medicine at Mount Sinai
last name: T. Scott Stroup, MD, MPH
role: Principal Investigator
affiliation: Columbia University
facility: 
facility: 
facility: 
facility: 
country: United States
citation: Kimhy D, Vakhrusheva J, Bartels MN, Armstrong HF, Ballon JS, Khan S, Chang RW, Hansen MC, Ayanruoh L, Lister A, Castren E, Smith EE, Sloan RP. The Impact of Aerobic Exercise on Brain-Derived Neurotrophic Factor and Neurocognition in Individuals With Schizophrenia: A Single-Blind, Randomized Clinical Trial. Schizophr Bull. 2015 Jul;41(4):859-68. doi: 10.1093/schbul/sbv022. Epub 2015 Mar 23.
PMID: 25805886
citation: Kimhy D, Lauriola V, Bartels MN, Armstrong HF, Vakhrusheva J, Ballon JS, Sloan RP. Aerobic exercise for cognitive deficits in schizophrenia - The impact of frequency, duration, and fidelity with target training intensity. Schizophr Res. 2016 Apr;172(1-3):213-5. doi: 10.1016/j.schres.2016.01.055. Epub 2016 Feb 3. No abstract available.
PMID: 26852401
citation: 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.
PMID: 26423100
citation: Armstrong HF, Bartels MN, Paslavski O, Cain D, Shoval HA, Ballon JS, Khan S, Sloan RP, Kimhy D. The impact of aerobic exercise training on cardiopulmonary functioning in individuals with schizophrenia. Schizophr Res. 2016 May;173(1-2):116-7. doi: 10.1016/j.schres.2016.03.009. Epub 2016 Mar 11. No abstract available.
PMID: 26976498
citation: Vakhrusheva J, Marino B, Stroup TS, Kimhy D. Aerobic Exercise in People with Schizophrenia: Neural and Neurocognitive Benefits. Curr Behav Neurosci Rep. 2016 Jun;3(2):165-175. doi: 10.1007/s40473-016-0077-2. Epub 2016 Apr 4.
PMID: 27766192
citation: Kimhy D, Vakhrusheva J, Bartels MN, Armstrong HF, Ballon JS, Khan S, Chang RW, Hansen MC, Ayanruoh L, Smith EE, Sloan RP. Aerobic fitness and body mass index in individuals with schizophrenia: Implications for neurocognition and daily functioning. Psychiatry Res. 2014 Dec 30;220(3):784-91. doi: 10.1016/j.psychres.2014.08.052. Epub 2014 Sep 3.
PMID: 25219618
citation: Ospina LH, Wall M, Jarskog LF, Ballon JS, McEvoy J, Bartels MN, Buchsbaum R, Sloan RP, Stroup TS, Kimhy D. Improving Cognition via Exercise (ICE): Study Protocol for a Multi-Site, Parallel-Group, Single-Blind, Randomized Clinical Trial Examining the Efficacy of Aerobic Exercise to Improve Neurocognition, Daily Functioning, and Biomarkers of Cognitive Change in Individuals with Schizophrenia. J Psychiatr Brain Sci. 2019;4:e190020. doi: 10.20900/jpbs.20190020. Epub 2019 Dec 30.
PMID: 31938726
responsible party type: Principal Investigator
investigator affiliation: Icahn School of Medicine at Mount Sinai
investigator full name: David Kimhy
investigator title: Associate Professor, Psychiatry
mesh term: Schizophrenia
sharing ipd: Undecided