Improving Cognition Via Exercise in Schizophrenia

Mount Sinai Health System

Status

Completed

Conditions

Schizophrenia and Related Disorders

Treatments

Behavioral: Stretching and Toning Exercise

Behavioral: Aerobic Exercise

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT03270098

1R01MH110623-01A1 (U.S. NIH Grant/Contract)

3R01MH110623-03S1 (U.S. NIH Grant/Contract)

GCO 17-1511

Details and patient eligibility

About

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.

Full 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.

Enrollment

104 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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)