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

Arno Schmidt-Trucksäss

Status: Enrolling

Conditions: Stress Related Disorder; Burnout; Depression

Treatments: Behavioral: Monitoring of physical activity and sleep; Diagnostic Test: Assessment of cognitive function, balance, strength and cardiorespiratory fitness; Diagnostic Test: Heart rate variability, blood pressure and pulse wave velocity; Behavioral: Monitoring of self-rated exhaustion, mood and tension

Study type: Observational

Funder types: Other

Identifiers

NCT05874856

2022-01871

Details and patient eligibility

About

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.

Enrollment: 153 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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
• suicidal thoughts precluding informed consent