Evaluating Cardiorespiratory Fitness in Patients with Severe Mental Illness
Validation and Impact of Cardiorespiratory Fitness in Severe Mental Illness - the Heart in Mind Project
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 |
|---|---|
| Enrollment | 75 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | University of Copenhagen Academic / other |
| Locations | 1 site (Glostrup Municipality) |
| Trial ID | NCT06743711 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 18-45 with a diagnosis of schizophrenia spectrum or affective disorders currently receiving antipsychotic treatment.
Not a fit: Patients with unstable psychiatric disorders or acute suicidal risk may not benefit from this study.
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 performed: While the approach of assessing CRF in psychiatric populations is gaining attention, this specific validation study is relatively novel.
Eligibility criteria
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 this trial is running
Glostrup Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.