Bipolar Affective Disorder, Schizophrenia Spectrum &Amp; Other Psychotic Disorders, Severe Mental Illness
Conditions
Keywords
cardiorespiratory fitness, severe mental illness, cardiovascular disease, validation, physical activity, cardiopulmonary exercise test, non-exercise vo2max estimation, vo2max
Brief 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.
Detailed description
BACKGROUND Cardiorespiratory fitness (CRF) is a strong independent predictor of cardiovascular disease (CVD) and all-cause mortality in the general population. However, CRF is rarely considered or measured in psychiatric populations, despite people with severe mental illness (SMI) is a high-risk population of CVD and may suffer from premature death of up to 15-20 years. AIM The aim of this project is to evaluate the feasibility, validity, and clinical relevance of CRF assessment in patients with SMI. POPULATION 50 people with severe mental illness in treatment with antipsychotic medications and 25 healthy controls without present or previous mental illness matched for sex, age, and BMI will be included in the study. METHODS This is a validation study with a cross-sectional design. The study includes a \ 3 hour baseline visit and 14 days of physical activity monitoring. Baseline Visit (D0) Physical health, body composition, vital signs, and non-exercise VO2max estimation by seismocardiography (SCG) will be carried out initially. Afterwards, psychopathology, substance use, and cognition will be assessed during an interview. Questionnaires regarding physical activity, fitness, quality of life, body image and self-esteem, and sleep will be completed by the participants. Essential for the baseline visit, two fitness tests will be conducted. First, the revised Ekblom-Bak submaximal cycle-ergometer fitness test followed by a state-of-the-art graded cardiopulmonary exercise test to exhaustion. During both tests, oxygen uptake will be assessed with gas-exchange analysis equipment. After the baseline visit, participants will wear a physical activity sensor (SENS Motion(R)) for two weeks, and finish participation in the study with completion of questionnaires.
Interventions
None listed
Sponsors
Bjorn H. Ebdrup
Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
VentriJect ApS
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Non-exercise estimated VO2max | At baseline visit (D0) | 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. |
Countries
Denmark
Contacts
CONTACTBjørn H Ebdrup, Professor and psychiatrist
CONTACTVictor Sørensen, PhD student
STUDY_DIRECTORBjørn H Ebdrup, Professor and psychiatrist
Mental Health Center Glostrup, Center for Neuropsychiatric Schizophrenia Research
PRINCIPAL_INVESTIGATORVictor Sørensen, PhD student
Mental Health Center Glostrup, Centre for Applied Research in Mental Health Care & Center for Neuropsychiatric Schizophrenia Research
Outcome results
None listed