Clinical trial NCT06743711: Validation and Impact of Cardiorespiratory Fitness in Severe Mental Illness - the Heart in Mind Project
Official title: Validation and Impact of Cardiorespiratory Fitness in Severe Mental Illness - the Heart in Mind Project
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Severe Mental Illness
Schizophrenia Spectrum &amp; Other Psychotic Disorders
Bipolar Affective Disorder
Keywords: cardiorespiratory fitness
severe mental illness
cardiovascular disease
validation
physical activity
cardiopulmonary exercise test
non-exercise vo2max estimation
vo2max
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Mental Health Services in the Capital Region, Denmark
name: VentriJect ApS
First posted: 2024-12-20
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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.

Primary outcomes:
measure: Validation of the revised Ekblom-Bak submaximal cycle-ergometer fitness test
timeFrame: At baseline visit (D0)
Secondary outcomes:
measure: Validation of non-exercise VO2max estimation by seismocardiography
timeFrame: At baseline visit (D0)
Other outcomes:
measure: Physical activity
timeFrame: From baseline to study end after 14 days
measure: Self-perceived fitness
timeFrame: At baseline visit and at study end after 14 days
measure: Psychopathology
timeFrame: At baseline visit (D0)
measure: Negative symptoms
timeFrame: At baseline visit (D0)
measure: Depressive symptoms
timeFrame: At baseline visit (D0)
measure: Global cognition
timeFrame: At baseline visit (D0)
measure: Sleep quality
timeFrame: At baseline visit (D0)
measure: Drug use
timeFrame: At baseline visit (D0)
measure: Alcohol use
timeFrame: At baseline visit (D0)
measure: Smoking
timeFrame: At baseline visit (D0)
measure: Quality of life
timeFrame: At baseline visit (D0)
measure: Body weight, image, and self esteem
timeFrame: At baseline visit (D0)
measure: Anthropometrics
timeFrame: At baseline visit (D0)
measure: Body composition
timeFrame: At baseline visit (D0)
measure: Blood pressure and resting heart rate
timeFrame: At baseline visit (D0)
measure: Electrocardiogram
timeFrame: At baseline visit (D0)
measure: Metabolic profile
timeFrame: At baseline visit (D0)
Locations:
city: Glostrup
country: Denmark
facility: Mental Health Center Glostrup
Study officials:
affiliation: Mental Health Center Glostrup, Center for Neuropsychiatric Schizophrenia Research
name: Bjørn H Ebdrup, Professor and psychiatrist
role: STUDY_DIRECTOR
affiliation: Mental Health Center Glostrup, Centre for Applied Research in Mental Health Care & Center for Neuropsychiatric Schizophrenia Research
name: Victor Sørensen, PhD student
role: PRINCIPAL_INVESTIGATOR
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