Severe Mental IllnessSchizophrenia Spectrum &Amp; Other Psychotic DisordersBipolar Affective Disorder
Study 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
Sex
ALL
Min age
18 Years
Max age
45 Years
Healthy 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.
Primary outcome measure(s)
Estimated VO2max — At baseline visit (D0) The revised Ekblom-Bak submaximal cycle-ergometer fitness test (EBsub) will be carried out to estimate VO2max and validated against measured VO2max during a cardiopulmonary exercise test (CPET) including calculation of coefficient variation, limits of agreement, mean absolute percentage error, linear regression analyses for obtaining R-squared values and standard errors of the estimate, and Bland-Altman plotting.
VO2max will be assessed during an incremental cycle protocol until exhaustion conforming to the state-of-the-art CPET. Oxygen consumption and carbon dioxide excretion rates will be measured using a "breath-by-breath" analysing system coupled to a fitted silicone mask, strapped around the participants head, covering nose and mouth (Vyntus CPX, Jaeger). VO2max will be defined as the average of the three highest oxygen consumption measurements.
VO2max will be estimated with the EBsub conforming to the developing authors guidelines.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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