Status:

COMPLETED

Improving Cognition Via Exercise in Schizophrenia

Lead Sponsor:

Icahn School of Medicine at Mount Sinai

Collaborating Sponsors:

University of North Carolina, Chapel Hill

Stanford University

Conditions:

Schizophrenia and Related Disorders

Eligibility:

All Genders

18-55 years

Phase:

NA

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 incr...

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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)

Key Trial Info

Start Date :

April 26 2018

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 31 2023

Estimated Enrollment :

104 Patients enrolled

Trial Details

Trial ID

NCT03270098

Start Date

April 26 2018

End Date

January 31 2023

Last Update

April 14 2023

Active Locations (4)

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Page 1 of 1 (4 locations)

1

Stanford University

Stanford, California, United States, 94305

2

Augusta University

Augusta, Georgia, United States, 30912

3

Icahn School of Medicine at Mount Sinai

New York, New York, United States, 10029

4

University of North Carolina

Chapel Hill, North Carolina, United States, 27599