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

Launched by BJORN H. EBDRUP · Dec 16, 2024

Keywords

ClinConnect Summary

The Heart in Mind Project is a clinical trial that aims to understand how to measure physical fitness in people with severe mental illnesses, such as schizophrenia and bipolar disorder. The study will include 50 participants with these mental health conditions and 25 healthy individuals to compare results. Participants will undergo three different tests to evaluate their fitness levels during an initial visit and will then be monitored for their physical activity over 14 days.

To participate, individuals with severe mental illness must be between 18 and 45 years old, currently receiving antipsychotic medication for at least a month, and able to provide informed consent. Healthy participants will also need to be in the same age range but should have no psychiatric diagnosis or family history of mental illness. This study is currently recruiting participants, and those who join can expect to contribute to important research that may improve how fitness is assessed and managed in people with severe mental illnesses.

Gender

ALL

Eligibility criteria

• • Patients
• Inclusion Criteria:
• • 1) 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.
• Exclusion Criteria:
• • 1) 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
• Inclusion Criteria:
• • 1) 18-45 years; 2) No psychiatric diagnosis or having first-degree relatives with psychiatric diagnoses; 3) able to give informed consent.
• Exclusion Criteria:
• • 1) Clinical or laboratory evidence of uncompensated medical disease; 2) Indication of psychiatric disorder.