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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05338424
Other study ID # PSYCH-2022-30666
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date July 1, 2022
Est. completion date September 30, 2022

Study information

Verified date October 2022
Source University of Minnesota
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Previous studies have shown that cardiorespiratory fitness (how well the heart and lungs are able to function during physical activity) is often reduced in people with psychosis. The goal of this research study is to test the hypothesis that aerobic exercise can lead to small changes in brain functioning that can influence visual perception and attention in psychosis. The type of aerobic exercise used in this study is called Sprint Interval Training, or "SIT". Information from this study will help to develop interventions that enhance cognition and maximize the quality of life for persons living with psychosis. The exercise procedure used is called SIT, which involves training rigorously on a stationary bike for a short period of time followed by a resting period.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date September 30, 2022
Est. primary completion date September 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 64 Years
Eligibility Inclusion Criteria: - Meet diagnostic criteria for schizophrenia or schizoaffective disorder - Are age 18-64 - Fluent in written and spoken English - Have an outpatient status of at least 1 month prior to participation - Has been on a stable dose of psychiatric medication for at least one month prior to participation (titration to a lower dose of psychotropic medications under supervision of a psychiatrist can be allowed at the discretion of the investigators) Exclusion Criteria: - Current or possibility of current pregnancy (self-reported) - Active suicidal ideation at screening or baseline assessments, or previous intent to act on suicidal ideation with a specific plan, preparatory acts, or an actual suicide attempt within the last 3 months, as indicated by the C-SSRS - WTAR standardized score below 70 - American College of Sports Medicine contraindication to exercise

Study Design


Intervention

Other:
Sprint Interval Training (SIT)
Active arm-- exercise dictated by protocol

Locations

Country Name City State
United States University of Minnesota Minneapolis Minnesota

Sponsors (1)

Lead Sponsor Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Individual Alpha Frequency A prominent neural oscillatory rhythm measured from resting EEG. through study completion, on average 2 weeks
Primary Change in Visual Attention Computerized tasks that measure speeded sustained attention. through study completion, on average 2 weeks
Primary Change in Visual Perception Computerized tasks that measure speeded visual perception through study completion, on average 2 weeks
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