Improving Cognition Via Exercise in Schizophrenia

NCT ID: NCT03270098

Last Updated: 2023-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-26
• Study Completion Date: 2023-01-31

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.

Conditions

Schizophrenia and Related Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Aerobic Exercise

Using trainer-led video calls with traditional callisthenic body movements (e.g., jumping jacks, burpees, etc.)

Group Type: EXPERIMENTAL

Aerobic Exercise

Intervention Type: BEHAVIORAL

Trainer-led one hour aerobic exercise sessions, three times per week, over 12 weeks.

Stretching and Toning Exercise

Using trainer-led video calls with stretching and toning exercises.

Group Type: ACTIVE_COMPARATOR

Stretching and Toning Exercise

Intervention Type: BEHAVIORAL

Trainer-led one hour stretching-and-toning exercise sessions, three times per week, over 12 weeks.

Interventions

Aerobic Exercise

Trainer-led one hour aerobic exercise sessions, three times per week, over 12 weeks.

Intervention Type: BEHAVIORAL

Stretching and Toning Exercise

Trainer-led one hour stretching-and-toning exercise sessions, three times per week, over 12 weeks.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: collaborator

Augusta University

OTHER

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

David Kimhy

Associate Professor, Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Kimhy, PhD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

T. Scott Stroup, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Stanford University

Stanford, California, United States

Augusta University

Augusta, Georgia, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

University of North Carolina

Chapel Hill, North Carolina, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 25805886 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26852401 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26423100 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26976498 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27766192 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25219618 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31938726 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33087170 (View on PubMed)

Other Identifiers

1R01MH110623-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

3R01MH110623-03S1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

GCO 17-1511

Identifier Type: -

Identifier Source: org_study_id