Evaluating Cardiorespiratory Fitness in Patients with Severe Mental Illness
Official title: Validation and Impact of Cardiorespiratory Fitness in Severe Mental Illness - the Heart in Mind Project
Run by University of Copenhagen · NCT06743711 · Data updated 2026-11-12
This study is testing how well we can measure fitness levels in people with severe mental illness to see if it can help improve their overall health.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 45 Years |
| Sex | All |
| Enrollment | 75 (estimated) |
| Sponsor | University of Copenhagen Academic / other |
| Locations | 1 site (Glostrup Municipality) |
| Status | Recruiting |
| Started | January 1, 2025 |
| Main results expected | June 30, 2026 |
| Study ends | June 30, 2026 |
| Registry record updated | May 4, 2026 |
| Trial ID | NCT06743711 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals aged 18-45 with a diagnosis of schizophrenia spectrum or affective disorders currently receiving antipsychotic treatment.
✕Probably not a fit
Patients with unstable psychiatric disorders or acute suicidal risk may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This project aims to assess the feasibility, validity, and clinical relevance of measuring cardiorespiratory fitness (CRF) in individuals with severe mental illness (SMI). It involves a cross-sectional design with 50 patients diagnosed with SMI and 25 healthy controls. Participants will undergo a baseline visit that includes physical health assessments, fitness tests, and a 14-day period of physical activity monitoring. The study seeks to highlight the importance of CRF in a population at high risk for cardiovascular disease.
Why it matters
Potential benefit: If successful, this study could lead to improved health outcomes for patients with severe mental illness by emphasizing the importance of physical fitness.
How similar studies have gone: While the approach of assessing CRF in psychiatric populations is gaining attention, this specific validation study is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18-45 years * Diagnosis within schizophrenia spectrum or affective disorders (i.e. F2.x or F3.x according to ICD-10 classification) * current antipsychotic treatment for more than one month on a regular daily dose * Able to give informed consent. Exclusion Criteria: * Clinical or laboratory evidence of uncompensated medical disease * Unstable psychiatric disorder * Acute suicidal risk * Planned hospitalization within the study period.
Where it's running
-
Mental Health Center Glostrup
Glostrup Municipality, Denmark Recruiting
Study contacts
- Principal investigator: Victor Sørensen, PhD student — Mental Health Center Glostrup, Centre for Applied Research in Mental Health Care & Center for Neuropsychiatric Schizophrenia Research
- Study coordinator: Bjørn H Ebdrup, Professor and psychiatrist
- Email: bjoern.ebdrup@regionh.dk
- Phone: +4538640840
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.