Validation and Impact of Cardiorespiratory Fitness in Severe Mental Illness - the Heart in Mind Project

Bjorn H. Ebdrup

Status: Enrolling

Conditions: Severe Mental Illness; Schizophrenia Spectrum & Other Psychotic Disorders; Bipolar Affective Disorder

Study type: Observational

Funder types: Other

Identifiers

NCT06743711

H-24031121 (Other Identifier)

2023-0065 (Other Grant/Funding Number)

Details and patient eligibility

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.

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

75 participants in 2 patient groups

Patients

Description:

Adults with severe mental illness in treatment with antipsychotic medications

Healthy controls

Description:

Adults without present or previous mental illness, and no first-degree relatives with present or previous mental illness, matched to the patient group for gender, age, and BMI.