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NCT06743711Recruiting

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

Source: ClinicalTrials.gov · Last updated 4 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
75 (estimated)
First submitted
16 Dec 2024
Start date
1 Jan 2025
Primary completion date
30 Jun 2026
Lead sponsor
Bjorn H. Ebdrup
NCT number
NCT06743711

What you commit to

  • Study type: Observational
  • Planned participants: 75
  • From 1 Jan 2025 to the primary completion date, 30 Jun 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Unstable psychiatric disorder

Lab values

  • Clinical or laboratory evidence of uncompensated medical disease

Other

  • Acute suicidal risk
  • Planned hospitalization within the study period.

Who the study is looking for

  • 18-45 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.

Age in the registry: 18 years to 45 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Mental Health Center Glostrup
Coordinator of this site? Confirm its status
Glostrup MunicipalityDenmarkRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.