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Validation and Impact of Cardiorespiratory Fitness in Severe Mental Illness - the Heart in Mind Project

RECRUITINGSponsored by Bjorn H. Ebdrup
Actively Recruiting
SponsorBjorn H. Ebdrup
Started2025-01-01
Est. completion2026-06-30
Eligibility
Age18 Years – 45 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06743711

Summary

This project aims to evaluate feasibility, validity and clinically applicability to systematically measure fitness in patients with severe mental illness. The research project is a validation study using a cross-sectional design. The project will include 50 people with severe mental illness and 25 healthy controls without present or previous mental illness. The protocol includes a baseline visit where three different ways of measure fitness will be carried out, and a 14-day period of physical activity monitoring.

Eligibility

Age: 18 Years – 45 YearsHealthy volunteers accepted
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.

Conditions4

Bipolar Affective DisorderHeart DiseaseSchizophrenia Spectrum & Other Psychotic DisordersSevere Mental Illness

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