Heart Rate Variability, Physical Activity and Exhaustion in the Inpatient Treatment of Stress-Related Disorders
NCT ID: NCT05874856
Last Updated: 2023-05-25
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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UNKNOWN
153 participants
OBSERVATIONAL
2023-02-08
2024-05-31
Brief Summary
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* whether heart rate variability shows the severity of certain symptoms.
* whether physical activity has an influence on heart rate variability and symptoms of stress-related disorder.
Participants will be asked to take part in 5 examinations during their up to 8-week inpatient treatment:
* Participate in an interview
* Measurement of heart rate variability, blood pressure and health of the arteries (pulse wave velocity)
* Tests of endurance, strength, balance and cognitive abilities
* Completion of two additional short questionnaires
* Wearing a 24-hour electrocardiogram
* Wearing a fitness watch and daily self-assessment of fatigue, mood and tension via an app on participant's mobile phone during their stay.
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Interventions
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Monitoring of physical activity and sleep
GENEActiv accelerometer will be worn on the wrist daily during 8-week inpatient treatment.
Monitoring of self-rated exhaustion, mood and tension
Using the customized PsyMate app.
Heart rate variability, blood pressure and pulse wave velocity
Resting HRV in supine and standing position, blood pressure and pulse wave velocity in supine position at first and last week of inpatient treatment
Assessment of cognitive function, balance, strength and cardiorespiratory fitness
THINC-it test for cognitive function; One-leg Standing test for balance assessment; 10-time chair rise test and hand grip test for strength assessment; Åstrand-Ryhming Test for cardiorespiratory fitness.
All assessments will be performed at first and last week of inpatient treatment.
Eligibility Criteria
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Inclusion Criteria
* German language skills
* mobile phone ownership
* age 18-35 years
Exclusion Criteria
* current treatment with antiarrhythmic drugs and tricyclic antidepressant medication
* factors precluding submaximal endurance test: history of cardiac diseases such as myocardial infarction, stroke and unstable heart failure within the previous six months impairing exercise testing and training, and heart failure (New York Heart Association functional class III and IV)
* factors severely affecting HRV parameters: type 1 \& 2 diabetes mellitus with clinically proven cardiovascular autonomic neuropathy, chronic obstructive pulmonary disease Global Initiative for Obstructive Lung Disease stage ≥ III, ongoing cancer treatment, moderate to severe chronic kidney disease (estimated Glomerular Filtration Rate stage 3a (G3a) or worse (≤ 45 ml/min)), current eating disorders such as anorexia nervosa and bulimia nervosa, excessive drug or alcohol abuse
* known pregnancy
* suicidal thoughts precluding informed consent
18 Years
65 Years
ALL
No
Sponsors
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Arno Schmidt-Trucksäss
OTHER
Responsible Party
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Arno Schmidt-Trucksäss
Prof. Dr. med. Arno Schmidt-Trucksäss
Principal Investigators
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Arno Schmidt-Trucksäss, Prof.
Role: PRINCIPAL_INVESTIGATOR
University of Basel
Locations
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Clinica Holistica Engiadina
Süs, Kanton Graubünden, Switzerland
Countries
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Central Contacts
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Facility Contacts
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References
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Turner W, Bruhl A, Boker H, Schulze B, Marschall K, La Marca R, Pfaff M, Russmann T, Schmidt-Trucksass A. Heart rate vARiability and physical activity in inpatient treatMent of burnOut and DepressIon (HARMODI): protocol of a cross-sectional study with up to 8-week follow up. BMJ Open. 2024 Jun 25;14(6):e081299. doi: 10.1136/bmjopen-2023-081299.
Other Identifiers
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2022-01871
Identifier Type: -
Identifier Source: org_study_id
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