Improving Cognition Via Exercise in Schizophrenia

Sponsor

Icahn School of Medicine at Mount Sinai (Other)

Overall Status

Recruiting

CT.gov ID

NCT03270098

Collaborator

University of North Carolina, Chapel Hill (Other), Stanford University (Other), Augusta University (Other), Columbia University (Other), National Institute of Mental Health (NIMH) (NIH)

200

Enrollment

Locations

Arms

53.2

Anticipated Duration (Months)

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia and Related Disorders	Behavioral: Aerobic Exercise Behavioral: Stretching and Toning Exercise	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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.

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Improving Cognition Via Exercise in Schizophrenia

Actual Study Start Date :

Apr 26, 2018

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Aerobic Exercise Using trainer-led video calls with traditional callisthenic body movements (e.g., jumping jacks, burpees, etc.)	Behavioral: Aerobic Exercise Trainer-led one hour aerobic exercise sessions, three times per week, over 12 weeks.
Active Comparator: Stretching and Toning Exercise Using trainer-led video calls with stretching and toning exercises.	Behavioral: Stretching and Toning Exercise Trainer-led one hour stretching-and-toning exercise sessions, three times per week, over 12 weeks.

Arm

Intervention/Treatment

Experimental: Aerobic Exercise

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

Behavioral: Aerobic Exercise

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

Active Comparator: Stretching and Toning Exercise

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

Behavioral: Stretching and Toning Exercise

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

Outcome Measures

Primary Outcome Measures

Change in the MATRICS Consensus Cognitive Battery (MCCB) [Baseline and 12 weeks]
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.
Change in VO2Max [Baseline and 12 weeks]
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.

Secondary Outcome Measures

Change in the Specific Levels of Functioning Scale (SLOF) [Baseline and 12 weeks]
The SLOF is a 43-item survey assessing multiple domains of daily functioning. Total score range from 43 to 215, with higher scores indicating better the overall functioning. Change in the SLOF at 12 weeks as compared to baseline.
Change in the UCSD Performance-based Skills Assessment (UPSA) [Baseline and 12 weeks]
The UPSA is performance-based measure of real-world daily functioning abilities. Participants receive scores for multiple domains, which are summed to create a summary score ranging from 0 to 100 with higher score indicating better overall functioning. Change in the UPSA at 12 weeks as compared to baseline.
Change in the Schizophrenia Cognition Rating Scale (SCoRS) [Baseline and 12 weeks]
The SCoRS is a 20-item clinician-administered interview assessing cognition-related daily functioning. Each item rated on a 4-point scale ranging from "no impairment" to "severe impairment". Total scores range from 20-80, with higher score indicating poorer functioning. Change in the SCoRS at 12 weeks as compared to baseline.
Serum BDNF [Baseline and 12 weeks]
BDNF is extracted from blood samples and serves as a biomarker of exercise-related cognitive changes. Change in the BDNF at 12 weeks as compared to baseline.
Change in Columbia Suicide Severity Rating Scale (C-SSRS) [Baseline and 12 weeks]
The C-SSRS is a semi-structured interview that measures 4 suicide risk related domains: ideation severity, ideation intensity, behavior, and lethality. Full scale from 1-10, with higher score indicating more suicidal ideation and behavior. Change in the C-SSRS at 12 weeks as compared to baseline.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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

Sponsors and Collaborators

Icahn School of Medicine at Mount Sinai
University of North Carolina, Chapel Hill
Stanford University
Augusta University
Columbia University
National Institute of Mental Health (NIMH)

Investigators

Principal Investigator: David Kimhy, PhD, Icahn School of Medicine at Mount Sinai
Principal Investigator: T. Scott Stroup, MD, MPH, Columbia University