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

Recruiting

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

• Registration Number: NCT06743711
• Lead Sponsor: Bjorn H. Ebdrup

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.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-16
• Study First Submitted QC: 2024-12-16
• Last Update Submitted: 2024-12-16
• Study First Posted: 2024-12-20
• Last Update Posted: 2024-12-20
• Study Start: 2025-01-01
• Primary Completion: 2026-01-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Validation of the revised Ekblom-Bak submaximal cycle-ergometer fitness test	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 Outcome Measures

Name	Time	Method
Validation of non-exercise VO2max estimation by seismocardiography	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.

Trial Locations

Locations (1)

Mental Health Center Glostrup; 🇩🇰 Glostrup, Denmark