Clinical trial NCT03270098: Improving Cognition Via Exercise in Schizophrenia
Official title: Improving Cognition Via Exercise in Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia and Related Disorders
Keywords: Schizophrenia
Aerobic Exercise
Cognition
Daily Functioning
Biomarkers
Brain Derived Neurotrophic Factor
Suicide Risk
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Chapel Hill
name: Stanford University
name: Augusta University
name: Columbia University
name: National Institute of Mental Health (NIMH)
First posted: 2017-09-01
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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 remote exercise training on cognition, suicide risk, daily functioning, and biomarkers of cognitive change and suicidality in people with schizophrenia.

Detailed description: 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.

Eligibility 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)

Primary outcomes:
measure: Change in the MATRICS Consensus Cognitive Battery (MCCB)
timeFrame: Baseline and 12 weeks
measure: Change in VO2Max
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Change in the Specific Levels of Functioning Scale (SLOF)
timeFrame: Baseline and 12 weeks
measure: Change in the UCSD Performance-based Skills Assessment (UPSA)
timeFrame: Baseline and 12 weeks
measure: Change in the Schizophrenia Cognition Rating Scale (SCoRS)
timeFrame: Baseline and 12 weeks
measure: Serum BDNF
timeFrame: Baseline and 12 weeks
measure: Change in Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: Baseline and 12 weeks
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: David Kimhy, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: T. Scott Stroup, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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: 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: 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: 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: 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: 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: 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: Beck-Felts K, Goodman M, Ospina LH, Wall M, McEvoy J, Jarskog LF, Ballon JS, Bartels MN, Buchsbaum R, Sloan RP, Stroup TS, Kimhy D. Suicide Reduction in Schizophrenia via Exercise (SUnRISE): study protocol for a multi-site, single-blind, randomized clinical trial of aerobic exercise for suicide risk reduction in individuals with schizophrenia. Trials. 2020 Oct 21;21(1):871. doi: 10.1186/s13063-020-04788-z.