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.
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.
Clinical or laboratory evidence of uncompensated medical disease
Unstable psychiatric disorder
Acute suicidal risk
Planned hospitalization within the study period.
Patients will be recruited from inpatient and outpatient clinics in the Capital Region of Denmark. Furthermore, recruitment will also be carried out through two ongoing randomized controlled trials i) Value of gym-based exercise training for young adults with severe mental illness: A pragmatic, single-blinded, multicenter randomized controlled trial - the Vega trial (NCT05461885), and ii) Effectiveness of a pragmatic, metabolic care clinic for patients with severe mental illness (NCT06624462). Healthy controls will be recruited through announcements in the Capital Region of Denmark, through the webpages www.forsøgsperson.dk and www.forskningnu.dk and social media.
Case-control
Cross-sectional
Not listed
Estimated VO2max
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.
Non-exercise estimated VO2max
Non-exercise VO2max estimation with seismocardiography (SCG) 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. Non-exercise VO2max estimation through SCG will be carried out with the Seismofit(R) (VentriJect, Denmark) device conforming to manifacturers instructions. Breifly, the Seismofit device will be mounted on the sternum, 2 cm proximal to the Xiphoid Process. Before estimation, age, height, weight, and sex of the participant is entered into the VentriJect app. The VO2max estimation lasts \~5min, including recording, data transfer, and signal processing.
MVPA (min/week)
Moderate-vigorous physical activity (MVPA) will be assessed with self-reported questionnaires: International Physical Activity Questionnaire (IPAQ) Physical Activity Vital Sign (PAVS) And objective measure: Accelorometry (SENS Motion(R))
Self-perceived fitness
self-perceived cardiorespiratory fitness on a 5-point Likert scale rating (i.e., very poor, poor, fair, good, very good) to the question; How do you rate you own physical fitness?
Psychopathology
Psychopathology will be assessed with the Positive and Negative Syndrome Scale (PANSS), which provides a structured format for clinicians to evaluate symptom severity in people with psychotic symptoms and/or schizophrenia. Clinicians rate the severity of each symptom on a scale ranging from 1 (not present) to 7 (extremely severe).
Negative symptoms
Negative symptoms will be assessed with The Brief Negative Symptom Scale (BNSS), which is a standardized clinical assessment tool designed to measure the severity of negative symptoms in individuals with schizophrenia spectrum disorders. Developed as a concise complement to existing scales, the BNSS focuses specifically on assessing five domains of negative symptoms: blunted affect, alogia, anhedonia, asociality, and avolition. Each domain is evaluated through a series of items, with clinicians rating the severity of each symptom on a scale from 0 (absent) to 6 (severe).
Click on the lead sponsor to view all of their trials.
Bjorn H. Ebdrup
Lead sponsor
University of Copenhagen
Sponsor institution
Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
Collaborator
VentriJect ApS
Collaborator
