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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-45
SponsorBjorn H. Ebdrup

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

Clinical or laboratory evidence of uncompensated medical disease

Unstable psychiatric disorder

Acute suicidal risk

Planned hospitalization within the study period.

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

75 Participants
are grouped into 2 trial groups

Sponsors and collaborators

Bjorn H. Ebdrup

Lead sponsor

University of Copenhagen

Sponsor institution

Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

Collaborator

VentriJect ApS

Collaborator