Actively Recruiting

Age: 18Years - 45Years
All Genders
Healthy Volunteers
NCT06743711

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

Led by Bjorn H. Ebdrup · Updated on 2026-05-04

75

Participants Needed

1

Research Sites

77 weeks

Total Duration

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Sponsors

B

Bjorn H. Ebdrup

Lead Sponsor

M

Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 45Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 45 years
  • Diagnosis within schizophrenia spectrum or affective disorders (F2.x or F3.x according to ICD-10)
  • Currently on regular daily antipsychotic treatment for more than one month
  • Able to provide informed consent
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Mental Health Center Glostrup

Glostrup Municipality, Denmark, 2600

Actively Recruiting

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Research Team

B

Bjørn H Ebdrup, Professor and psychiatrist

CONTACT

V

Victor Sørensen, PhD student

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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