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

Arno Schmidt-Trucksäss1 site in 1 country153 target enrollmentFebruary 8, 2023

ConditionsDepression Burnout Stress Related Disorder

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Depression
Sponsor: Arno Schmidt-Trucksäss
Enrollment: 153
Locations: 1
Primary Endpoint: Change from Baseline Orthostatic Test Heart Rate Variability (HRV) at 8 weeks.
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 8, 2023

End Date

May 2024

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Arno Schmidt-Trucksäss

Responsible Party

Sponsor Investigator

Principal Investigator

Arno Schmidt-Trucksäss

Prof. Dr. med. Arno Schmidt-Trucksäss

University of Basel

Eligibility Criteria

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 according to medical history:
•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

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

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

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

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

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

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

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

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

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

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

Secondary Outcomes

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.)
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.)
Mood with a total score of the 14-item German version of the Snaith-Hamilton-Pleasure Scale.(Mood will be measured in the first and last 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.)
Daily tension level will be measured with a daily score rated with the single item "How tense do you feel at the moment?".(Level of tension daily during up to 8-week inpatient treatment)
Attention function will be measured in mean latency for correct responses in milliseconds.(Cognitive function, such as attention function will be measured in the first and last week of up to 8-week inpatient treatment.)
Current mood will be shown in total scores of the Multidimensional Mood Questionnaire.(Current mood will be measured in the first and last week of up to 8-week inpatient treatment before the HRV measurement.)
Daily tiredness displayed with a daily score rated with the single item "How tired do you feel at the moment?"(Level of tiredness daily during 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.)
Anxiety severity will be displayed with a total score of the 21-item Beck Anxiety Inventory.(Anxiety severity will be measured in the first and last week of up to 8-week inpatient treatment.)
Daily mentally exhaustion displayed with the score rated with the single item "How mentally exhausted do you feel at the moment?".(Level of mentally exhaustion daily during up to 8-week inpatient treatment)
Balance performance in seconds, tested with a variation of the One-Leg Standing test.(Balance 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 self-rated 5-item Perceived Deficits Questionnaire.(Cognitive function will be self-rated in the first and last week of up to 8-week inpatient treatment.)
Working memory will be displayed in number of correct responses to the Symbol Check test.(Cognitive function, such as working memory will be measured in the first and last week of up to 8-week inpatient treatment.)
Ability to concentrate will be tested with the total number of correct responses to the Codebreaker test.(Cognitive function, such as ability to concentrate will be measured in the first and last week of up to 8-week inpatient treatment.)
Self-reported physical activity, objective measured physical activity and sleep displayed in average minutes per day.(Self-reported physical activity will be screened ones during first week of inpatient treatment. Objective measured physical activity and sleep daily during up to 8-week inpatient treatment.)
Leg strength in time needed to complete the test in seconds, tested with the 10-time chair-rise test.(Leg strength will be measured in the first and last week of up to 8-week inpatient treatment.)
Cardiovascular health will be depicted as central systolic and diastolic blood pressure (in mm Hg).(Cardiovascular health, such as central systolic and diastolic blood pressure will be assessed in the first and last week of up to 8-week inpatient treatment.)
Cardiovascular health will be depicted with pulse wave velocity in m/s.(Cardiovascular health, such as pulse wave velocity will be assessed in the first and last week of up to 8-week inpatient treatment.)
Executive function will be shown in time taken to complete the Trails test in seconds.(Cognitive function, such as executive function will be measured in the first and last week of up to 8-week inpatient treatment.)
Hand grip strength in kg.(Hand grip strength will be assessed in the first and last week of up to 8-week inpatient treatment.)
Cardiovascular health will be depicted as brachial systolic and diastolic blood pressure (in mm Hg).(Cardiovascular health, such as brachial systolic and diastolic blood pressure will be assessed in the first and last week of up to 8-week inpatient treatment.)