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

NCT06743711 | Recruiting DMC

• 3 other identifiers: H-240311212023-0065Grant
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

cardiorespiratory fitness; severe mental illness; cardiovascular disease; validation; physical activity; cardiopulmonary exercise test; non-exercise vo2max estimation; vo2max

Outcome Measures

Primary Outcomes (1)

• 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.

  At baseline visit (D0)

Secondary Outcomes (1)

• Non-exercise estimated VO2max

  At baseline visit (D0)

Other Outcomes (15)

• MVPA (min/week)

  From baseline to study end after 14 days

• Self-perceived fitness

  At baseline visit and at study end after 14 days

• Psychopathology

  At baseline visit (D0)

Study Arms (2)

Patients

Adults with severe mental illness in treatment with antipsychotic medications

Healthy controls

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.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Clinical or laboratory evidence of uncompensated medical disease
• Unstable psychiatric disorder
• Acute suicidal risk
• Planned hospitalization within the study period.

Sponsors & Collaborators

• Bjorn H. Ebdrup: lead
• VentriJect ApS: collaborator
• Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital: collaborator

Study Sites (1)

Mental Health Center Glostrup

Glostrup Municipality, 2600, Denmark

RECRUITING

Related Links

• Heart in Mind

MeSH Terms

Conditions

Mental Disorders; Bipolar Disorder; Cardiovascular Diseases; Motor Activity

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Behavior

Study Officials

• Bjørn H Ebdrup, Professor and psychiatrist

  Mental Health Center Glostrup, Center for Neuropsychiatric Schizophrenia Research

  STUDY DIRECTOR

• Victor Sørensen, PhD student

  Mental Health Center Glostrup, Centre for Applied Research in Mental Health Care & Center for Neuropsychiatric Schizophrenia Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bjørn H Ebdrup, Professor and psychiatrist

CONTACT

+4538640840; bjoern.ebdrup@regionh.dk

Victor Sørensen, PhD student

CONTACT

+4523722837; victor.soerensen@regionh.dk

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor and consultant psychiatrist

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 20, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

DK (1)