Validation and Impact of Cardiorespiratory Fitness in Severe Mental Illness - the Heart in Mind Project
Recruiting · NCT06743711 · Observational (researchers observe without assigning treatment) · Lead sponsor: Bjorn H. Ebdrup
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
18 Years to 45 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 is running
1 location listed.
- Mental Health Center Glostrup - Glostrup Municipality, Denmark