Validation and Impact of Cardiorespiratory Fitness in Severe Mental Illness - the Heart in Mind Project
NCT ID: NCT06743711
Last Updated: 2024-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
75 participants
OBSERVATIONAL
2025-01-01
2026-01-01
Brief Summary
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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.
Detailed Description
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AIM The aim of this project is to evaluate the feasibility, validity, and clinical relevance of CRF assessment in patients with SMI.
POPULATION 50 people with severe mental illness in treatment with antipsychotic medications and 25 healthy controls without present or previous mental illness matched for sex, age, and BMI will be included in the study.
METHODS This is a validation study with a cross-sectional design. The study includes a \~3 hour baseline visit and 14 days of physical activity monitoring.
Baseline Visit (D0) Physical health, body composition, vital signs, and non-exercise VO2max estimation by seismocardiography (SCG) will be carried out initially. Afterwards, psychopathology, substance use, and cognition will be assessed during an interview. Questionnaires regarding physical activity, fitness, quality of life, body image and self-esteem, and sleep will be completed by the participants.
Essential for the baseline visit, two fitness tests will be conducted. First, the revised Ekblom-Bak submaximal cycle-ergometer fitness test followed by a state-of-the-art graded cardiopulmonary exercise test to exhaustion. During both tests, oxygen uptake will be assessed with gas-exchange analysis equipment. After the baseline visit, participants will wear a physical activity sensor (SENS Motion(R)) for two weeks, and finish participation in the study with completion of questionnaires.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Patients
Adults with severe mental illness in treatment with antipsychotic medications
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 1\) 18-45 years; 2) No psychiatric diagnosis or having first-degree relatives with psychiatric diagnoses; 3) able to give informed consent.
Exclusion Criteria
Healthy controls
* 1\) Clinical or laboratory evidence of uncompensated medical disease; 2) Indication of psychiatric disorder.
18 Years
45 Years
ALL
Yes
Sponsors
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Mental Health Services in the Capital Region, Denmark
OTHER
VentriJect ApS
INDUSTRY
Bjorn H. Ebdrup
OTHER
Responsible Party
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Bjorn H. Ebdrup
Professor and consultant psychiatrist
Principal Investigators
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Bjørn H Ebdrup, Professor and psychiatrist
Role: STUDY_DIRECTOR
Mental Health Center Glostrup, Center for Neuropsychiatric Schizophrenia Research
Victor Sørensen, PhD student
Role: PRINCIPAL_INVESTIGATOR
Mental Health Center Glostrup, Centre for Applied Research in Mental Health Care & Center for Neuropsychiatric Schizophrenia Research
Locations
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Mental Health Center Glostrup
Glostrup Municipality, , Denmark
Countries
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Central Contacts
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Bjørn H Ebdrup, Professor and psychiatrist
Role: CONTACT
Phone: +4538640840
Email: [email protected]
Facility Contacts
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Bjørn H Ebdrup, Professor and psychiatrist
Role: primary
Victor Sørensen, PhD student
Role: backup
Related Links
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Other Identifiers
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2023-0065
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
H-24031121
Identifier Type: OTHER
Identifier Source: secondary_id
H-24031121
Identifier Type: -
Identifier Source: org_study_id