NCT05338424

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 21, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

October 10, 2022

Status Verified

October 1, 2022

Enrollment Period

3 months

First QC Date

April 4, 2022

Last Update Submit

October 6, 2022

Conditions

Keywords

PsychosisSchizophreniaSchizoaffective DisorderExerciseCognitionAttention

Outcome Measures

Primary Outcomes (3)

  • Change in Individual Alpha Frequency

    A prominent neural oscillatory rhythm measured from resting EEG.

    through study completion, on average 2 weeks

  • Change in Visual Attention

    Computerized tasks that measure speeded sustained attention.

    through study completion, on average 2 weeks

  • Change in Visual Perception

    Computerized tasks that measure speeded visual perception

    through study completion, on average 2 weeks

Study Arms (2)

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.

Other: Sprint Interval Training (SIT)

Stretching

Stretching will include a low-intensity range of motion and stretching exercises with session duration (15 minutes) being matched to SIT.

Interventions

Active arm-- exercise dictated by protocol

Sprint Interval Training (SIT)

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Individuals in good health with a psychotic disorder.

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Psychotic DisordersSchizophreniaMotor Activity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBehavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ian Ramsay

    University of Minnesota

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2022

First Posted

April 21, 2022

Study Start

July 1, 2022

Primary Completion

September 30, 2022

Study Completion

September 30, 2022

Last Updated

October 10, 2022

Record last verified: 2022-10

Locations