RecruitingNCT06743711

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

Sponsor

Bjorn H. Ebdrup

Enrollment

75 participants

Start Date

Jan 1, 2025

Study Type

OBSERVATIONAL

Conditions

Bipolar Affective Disorder Severe Mental Illness Schizophrenia Spectrum & Other Psychotic Disorders

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

Min Age: 18 YearsMax Age: 45 Years

Inclusion Criteria3

Patients
\) 18-45 years; 2) Diagnosis within schizophrenia spectrum or affective disorders (i.e. F2.x or F3.x according to ICD-10 classification); 3) current antipsychotic treatment for more than one month on a regular daily dose and 4) Able to give informed consent.
\) 18-45 years; 2) No psychiatric diagnosis or having first-degree relatives with psychiatric diagnoses; 3) able to give informed consent.

Exclusion Criteria3

\) Clinical or laboratory evidence of uncompensated medical disease; 2) Unstable psychiatric disorder; 3) Acute suicidal risk; 4) Planned hospitalization within the study period.
Healthy controls
\) Clinical or laboratory evidence of uncompensated medical disease; 2) Indication of psychiatric disorder.

Locations(1)

Mental Health Center Glostrup

Glostrup Municipality, Denmark

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NCT06743711

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