Actively Recruiting
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
N/A
Total Duration
On this page
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
Researchers are investigating how to measure cardiorespiratory fitness (CRF) in people with severe mental illness (SMI), a group at high risk for cardiovascular disease and early death. This study aims to see if CRF measurements are feasible, valid, and clinically useful in this population by comparing 50 patients with SMI to 25 healthy adults without mental illness. Participants will have a baseline visit lasting about three hours, where various assessments will be done including physical health checks, body composition, vital signs, and fitness tests such as the revised Ekblom-Bak submaximal cycle-ergometer test and a maximal graded cardiopulmonary exercise test. They will also complete questionnaires about physical activity, quality of life, body image, self-esteem, and sleep. After this visit, participants will wear a physical activity sensor for 14 days to monitor movement and activity levels. Throughout the study, researchers will estimate participants' VO2max, a measure of fitness, using gas-exchange analysis and seismocardiography. They will assess mental health, substance use, and cognition through interviews. The study concludes after two weeks of activity monitoring and final questionnaires. The total participation time varies but includes the initial visit and two weeks of physical activity tracking.
CONDITIONS
Brief Title
Validation and Impact of Cardiorespiratory Fitness in Severe Mental Illness - the Heart in Mind Project
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ages 18 to 45 years
- Diagnosis within schizophrenia spectrum or affective disorders (F2.x or F3.x ICD-10 classification)
- On regular daily antipsychotic treatment for more than one month
- Able to provide informed consent
You will not qualify if you...
- Presence of serious medical conditions not controlled
- 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants complete a baseline visit including physical health assessments, fitness tests, interviews, and questionnaires to evaluate cardiorespiratory fitness and related factors.
1 baseline visit (approximately 3 hours, in-person)
Duration - 14 days
Participants wear a physical activity sensor for 14 days to monitor their physical activity levels and complete final questionnaires.
Continuous activity monitoring for 14 days with no additional visits
Trial Site Locations
Total: 1 location
1
Mental Health Center Glostrup
Glostrup Municipality, Denmark, 2600
Actively Recruiting
Research Team
B
Bjørn H Ebdrup, Professor and psychiatrist
V
Victor Sørensen, PhD student
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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