PsychosisNCT05338424
Exercise Target Brain Oscillations in Psychosis
An observational study of Psychosis and Schizophrenia, run by University of Minnesota at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Psychosis, Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Sprint Interval Training (SIT)
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2022to 30 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Study population: Individuals in good health with a psychotic disorder.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: 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.
- Conditions
- Psychosis, Schizophrenia, Schizoaffective Disorder
- Being tested
- Sprint Interval Training (SIT)
- Keywords
- Psychosis, Schizophrenia, Schizoaffective Disorder, Exercise, Cognition, Attention
- Medical subject headings
- Psychotic Disorders, Schizophrenia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sprint Interval Training (SIT)Other
Active arm-- exercise dictated by protocol
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Individual Alpha Frequency
A prominent neural oscillatory rhythm measured from resting EEG.
Measured: through study completion, on average 2 weeks
Change in Visual Attention
Computerized tasks that measure speeded sustained attention.
Measured: through study completion, on average 2 weeks
Change in Visual Perception
Computerized tasks that measure speeded visual perception
Measured: through study completion, on average 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start1 Jul 2022
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Why it stopped: Principal Investigator left the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ian Ramsay, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05338424
- Sponsor's protocol ID
- PSYCH-2022-30666
- Status last verified
- Oct 2022
- First submitted
- 4 Apr 2022
- Last updated
- 10 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sprint Interval Training to Target Brain Oscillations in Psychosis
- ClinicalTrials.gov ID
- NCT05338424
- Acronym / sponsor ID
- PSYCH-2022-30666
- Conditions
- Psychosis, Schizophrenia, Schizoaffective Disorder
- Keywords
- Psychosis, Schizophrenia, Schizoaffective Disorder, Exercise, Cognition, Attention
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Principal Investigator left the institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 21 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sprint Interval Training (SIT) | – | Other: 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. |
| Stretching | – | –Stretching will include a low-intensity range of motion and stretching exercises with session duration (15 minutes) being matched to SIT. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Individuals in good health with a psychotic disorder.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sprint Interval Training (SIT)Active arm-- exercise dictated by protocol | Other | Sprint Interval Training (SIT) |
Primary outcome
Change in Individual Alpha Frequency
Time frame: through study completion, on average 2 weeks
A prominent neural oscillatory rhythm measured from resting EEG.
Change in Visual Attention
Time frame: through study completion, on average 2 weeks
Computerized tasks that measure speeded sustained attention.
Change in Visual Perception
Time frame: through study completion, on average 2 weeks
Computerized tasks that measure speeded visual perception
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ian Ramsay principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychosis and Schizophrenia, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Individual Alpha Frequency (time frame: through study completion, on average 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2022.