- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05338424
Exercise Target Brain Oscillations in Psychosis
Sprint Interval Training to Target Brain Oscillations in Psychosis
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Contacts and Locations
Study Locations
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University of Minnesota
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Sprint Interval Training (SIT)
The 1-session SIT protocol will include "Work" bouts performed at maximal intensity targets.
Three "Work" bouts will be performed at 20-second intervals separated by 2 recovery bouts consisting of 2 minutes of low-intensity cycling.
The SIT session will employ a standardized warm up and cool down of 3 minutes at a self-selected light intensity, per current guidelines.
SIT sessions will take 15 minutes to complete.
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Active arm-- exercise dictated by protocol
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Stretching
Stretching will include a low-intensity range of motion and stretching exercises with session duration (15 minutes) being matched to SIT.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Individual Alpha Frequency
Time Frame: through study completion, on average 2 weeks
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A prominent neural oscillatory rhythm measured from resting EEG.
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through study completion, on average 2 weeks
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Change in Visual Attention
Time Frame: through study completion, on average 2 weeks
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Computerized tasks that measure speeded sustained attention.
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through study completion, on average 2 weeks
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Change in Visual Perception
Time Frame: through study completion, on average 2 weeks
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Computerized tasks that measure speeded visual perception
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through study completion, on average 2 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ian Ramsay, University of Minnesota
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PSYCH-2022-30666
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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