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

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

153 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-08

Study Completion Date

2024-05-31

Brief Summary

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The goal of this observational study is to learn about heart rate variability and physical activity in inpatients with stress-related disorder. The main questions to answer are:

* 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.

Detailed Description

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Conditions

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Depression Burnout Stress Related Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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.

Intervention Type BEHAVIORAL

Monitoring of self-rated exhaustion, mood and tension

Using the customized PsyMate app.

Intervention Type BEHAVIORAL

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

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* diagnosis of an ICD-10 depressive episode (F32 or F33) and burnout (Z73) without psychotic symptoms
* German language skills
* mobile phone ownership
* age 18-35 years

Exclusion Criteria

* comorbid psychiatric disorder, including post-traumatic stress disorder as well as anxiety and panic disorder
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Arno Schmidt-Trucksäss

OTHER

Sponsor Role lead

Responsible Party

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Arno Schmidt-Trucksäss

Prof. Dr. med. Arno Schmidt-Trucksäss

Responsibility Role SPONSOR_INVESTIGATOR

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

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Arno Schmidt-Trucksäss, Prof.

Role: CONTACT

+41612074741

Michael Pfaff, Dr.

Role: CONTACT

+41 81 300 20 37

Facility Contacts

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Wiebke Turner, MoA

Role: primary

+41 81 300 26 75

Michael Pfaff, Dr.

Role: backup

+41 81 300 20 37

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.

Reference Type DERIVED
PMID: 38925684 (View on PubMed)

Other Identifiers

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2022-01871

Identifier Type: -

Identifier Source: org_study_id

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