Heart Rate Variability, Physical Activity and Exhaustion in the Inpatient Treatment of Stress-Rel… (NCT05874856) | Clinical Trial Compass
UnknownNot Applicable
Heart Rate Variability, Physical Activity and Exhaustion in the Inpatient Treatment of Stress-Related Disorders
Switzerland153 participantsStarted 2023-02-08
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from Baseline Orthostatic Test Heart Rate Variability (HRV) at 8 weeks.
Timeframe: Orthostatic Test HRV will be measured in the first and last week of up to 8-week inpatient treatment.
2
Change from Baseline 24-hour Heart Rate Variability (HRV) at 8 weeks.
Timeframe: 24-hour HRV will be measured in the first and last week of up to 8-week inpatient treatment.
3
Change from Baseline Exercise Test Heart Rate Variability (HRV) at 8 weeks.
Timeframe: Exercise Test HRV will be measured in the first and last week of up to 8-week inpatient treatment.