NCT03270098

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

April 26, 2018

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

April 14, 2023

Status Verified

April 1, 2023

Enrollment Period

4.8 years

First QC Date

August 30, 2017

Last Update Submit

April 12, 2023

Conditions

Schizophrenia and Related Disorders

Keywords

SchizophreniaAerobic ExerciseCognitionDaily FunctioningBiomarkersBrain Derived Neurotrophic FactorSuicide Risk

Outcome Measures

Primary Outcomes (2)

  • Change in the MATRICS Consensus Cognitive Battery (MCCB)

    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.

    Baseline and 12 weeks

  • Change in VO2Max

    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.

    Baseline and 12 weeks

Secondary Outcomes (5)

  • Change in the Specific Levels of Functioning Scale (SLOF)

    Baseline and 12 weeks

  • Change in the UCSD Performance-based Skills Assessment (UPSA)

    Baseline and 12 weeks

  • Change in the Schizophrenia Cognition Rating Scale (SCoRS)

    Baseline and 12 weeks

  • Serum BDNF

    Baseline and 12 weeks

  • Change in Columbia Suicide Severity Rating Scale (C-SSRS)

    Baseline and 12 weeks

Study Arms (2)

Aerobic Exercise

EXPERIMENTAL

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

Behavioral: Aerobic Exercise

Stretching and Toning Exercise

ACTIVE COMPARATOR

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

Behavioral: Stretching and Toning Exercise

Interventions

Aerobic ExerciseBEHAVIORAL

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

Aerobic Exercise
Stretching and Toning ExerciseBEHAVIORAL

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

Stretching and Toning Exercise

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Stanford University

Stanford, California, 94305, United States

Location

Augusta University

Augusta, Georgia, 30912, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (8)

  • 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: 25805886BACKGROUND

  • 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: 26852401BACKGROUND

  • 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: 26423100BACKGROUND

  • 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: 26976498BACKGROUND

  • 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: 27766192BACKGROUND

  • 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: 25219618BACKGROUND

  • 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: 31938726BACKGROUND

  • 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.

    PMID: 33087170DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

Exercise

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • David Kimhy, PhD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

  • T. Scott Stroup, MD, MPH

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Psychiatry

Study Record Dates

First Submitted

August 30, 2017

First Posted

September 1, 2017

Study Start

April 26, 2018

Primary Completion

January 31, 2023

Study Completion

January 31, 2023

Last Updated

April 14, 2023

Record last verified: 2023-04

Locations

US(4)