N/A
N=50
Exercise and Markers of Medial Temporal Health in Youth At-risk for Psychosis
Attenuated Psychosis Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT02155699 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Brain Volume — 19.8; 54.8; -0.489; -6.28 Change in mm cubed (baseline -followup)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Exercise 1 (Behavioral); Exercise 2 (Behavioral)
- Age
- Pediatric, Adult · 16+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Boulder
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Brain Volume |
19.8; 54.8; -0.489; -6.28 | — |
| SECONDARY Working Memory Assessment |
47.5; 53; 2.75; 3.00; 3.73; 3.13 | — |
Summary
The goal of this proposal is to test the feasibility and effectiveness of cardiovascular exercise in promoting brain health and improving related symptoms (e.g., hearing sounds that are not there, feeling emotionally detached from self and others), cognitive difficulties (troubles with memory and learning), and every day social-occupational functioning in youth at imminent risk for developing a psychotic disorder such as schizophrenia. Understanding how exercise may protect or improve the health of a brain area that is implicated as a major contributing factor to the onset of psychosis may lead to a path-breaking new intervention that does not suffer from many of the side effects, costs, and other barriers that characterize treatments that are currently available for this group. Because a significant portion of high-risk youth go on to develop a psychotic disorder in a short period, intervening at this stage may help to improve the clinical course and ultimately prevent the onset of a devastating and prevalent mental illness.
Eligibility Criteria
Inclusion Criteria
- age 16-24
- no history of brain injury or neurological disease
- no contraindications to exercise training (as assessed by a Clinical Translational Research Center CTRC physician)
- no history or current treatment with antipsychotics
- no contraindications for being in an magnetic resonance imaging scanner.
- meet criteria for a prodromal syndrome based upon the Structure Interview for Prodromal Syndromes (SIPS) interview.
Exclusion Criteria
- people who are extremely claustrophobic
- have a history of significant head injury
- other physical disorder that could affect brain functioning
- mental retardation
- history of substance use disorder within 6 months of screening interview
- have a psychotic disorder (at study entry) and/or have exhibited serious self-harm behaviors
- pregnant females
- people who have contraindications to magnetic resonance (MR) scanning including intracranial, intraorbital or intraspinal metal, pacemakers, cochlear implants or other non-MR-compatible devices
- inability of the subject or their parent/guardian to understand the informed consent document
- meeting criteria for an Axis I psychotic disorder
Data sourced from ClinicalTrials.gov (NCT02155699). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.