Heart Rate Variability, Physical Activity and Exhaustion in the Inpatient Treatment of Stress-Related Disorders

NCT05874856 | Unknown

• 1 other identifier: 2022-01871
• Study Type: observational
• Target: 153
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression; Burnout; Stress Related Disorder

Keywords

Stress Related Disorder; Heart Rate Variability; Physical Activity; Exhaustion; Inpatient Treatment; Cardiorespiratory fitness

Outcome Measures

Primary Outcomes (3)

• Change from Baseline Orthostatic Test Heart Rate Variability (HRV) at 8 weeks.

  Particular focus is RMSSD in milliseconds, a robust parasympathetic nervous system parameter that is less influenced by body movement and breathing.

  Orthostatic Test HRV will be measured in the first and last week of up to 8-week inpatient treatment.

• Change from Baseline 24-hour Heart Rate Variability (HRV) at 8 weeks.

  Particular focus is RMSSD in milliseconds, a robust parasympathetic nervous system parameter that is less influenced by body movement and breathing.

  24-hour HRV will be measured in the first and last week of up to 8-week inpatient treatment.

• Change from Baseline Exercise Test Heart Rate Variability (HRV) at 8 weeks.

  Particular focus is RMSSD in milliseconds, a robust parasympathetic nervous system parameter that is less influenced by body movement and breathing.

  Exercise Test HRV will be measured in the first and last week of up to 8-week inpatient treatment.

Secondary Outcomes (23)

• Change from baseline cardiorespiratory fitness at 8 weeks.

  Cardiorespiratory fitness will be measured in the first and last week of up to 8-week inpatient treatment.

• Global score of the Hamburger Burnout Inventory (HBI) to assess the severity of the burnout syndrome.

  Severity of Burnout syndrome will be measured in the first week of up to 8-week inpatient treatment.

• Total score of the Shirom-Melamed-Burnout-Measure (SMBM) will be used measure exhaustion at the beginning of inpatient treatment.

  Exhaustion will be measured in the first week of up to 8-week inpatient treatment.

• Depression severity will be evaluated with a total score of the German version of the 21-item Beck Depression Inventory-II.

  Depression severity will be measured in the first and last week of up to 8-week inpatient treatment.

• Change of Vital exhaustion with a total score of the 9-item short form of the original 21-item Maastricht Vital Exhaustion Questionnaire (MVEQ).

  Vital exhaustion will be measured in the first and last week of up to 8-week inpatient treatment.

Interventions

Heart rate variability, blood pressure and pulse wave velocity DIAGNOSTIC_TEST

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 DIAGNOSTIC_TEST

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.

Monitoring of physical activity and sleep BEHAVIORAL

GENEActiv accelerometer will be worn on the wrist daily during 8-week inpatient treatment.

Monitoring of self-rated exhaustion, mood and tension BEHAVIORAL

Using the customized PsyMate app.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited among patients referred to the rehabilitation clinic with the diagnosis of an ICD-10 depressive episode (F32 or F33) and burnout (Z73), confirmed by experienced psychiatrists working in the clinic.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arno Schmidt-Trucksäss: lead

Study Sites (1)

Clinica Holistica Engiadina

Süs, Kanton Graubünden, 7542, Switzerland

RECRUITING

Related Publications (1)

• 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.

  PMID: 38925684 DERIVED

MeSH Terms

Conditions

Depression; Burnout, Psychological; Motor Activity

Interventions

Blood Pressure; Pulse Wave Analysis; Cardiorespiratory Fitness; Sleep

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Stress, Psychological

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Diagnostic Techniques, Cardiovascular; Physical Fitness; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health; Population Characteristics; Nervous System Physiological Phenomena

Study Officials

• Arno Schmidt-Trucksäss, Prof.

  University of Basel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arno Schmidt-Trucksäss, Prof.

CONTACT

+41612074741; arno.schmidt-trucksaess@unibas.ch

Michael Pfaff, Dr.

CONTACT

+41 81 300 20 37; m.pfaff@clinica-holistica.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med. Arno Schmidt-Trucksäss

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: May 25, 2023
• Study Start: February 8, 2023
• Primary Completion: April 1, 2024
• Study Completion: May 1, 2024
• Last Updated: May 25, 2023

Record last verified: 2023-05

Locations

CH (1)