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The aim for this study is further to elucidate the presence of dysautonomia in post-covid-19 patients, by evaluating heart rate variability.
The COVID-19 pandemic is currently a serious global public health concern. This disease is caused by a novel coronavirus which was first discovered in Wuhan, China in 2019 and later spread rapidly throughout the world. Symptoms of the disease can manifest as fever, cough, encephalitis, myalgia, fatigue, muscle weakness, arthralgia, anosmia, and impairment in other bodily functions in the acute phase. In 17% to 67% of cases, COVID-19 patients will develop acute respiratory distress syndrome (ARDS) and critical illness. Besides the impact on the respiratory system, coronaviruses have an effect on other systems including the central nervous system, cardiovascular system, musculoskeletal system, and gastrointestinal system.
Potential long-term secondary effects on the musculoskeletal system such as muscle weakness, decreased muscle mass, and myopathies have been brought under attention. Persisting symptoms in patients recovered from COVID-19 infection are frequently a complaint with at least 1 symptom, particularly fatigue and dyspnea. In recent papers, the authors commented on the potential role of dysautonomia in the post-covid-19 entity related to microangiopathy and endothelial injury. Such lesions were already reported in brain biopsy samples of severe COVID-19.
Therefore, the aim of this study is further to elucidate the presence of dysautonomia in post-covid-19 patients, by evaluating heart rate variability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Covid-19 infected patients | In this study male and female patients who were previously infected with covid-19 (symptomatic and asymptomatic) will be included. Patients will only be eligible if they had a positive covid-19 test before inclusion in the study. More specifically, only patients who had a positive COVID-19 test 2 to 8 weeks before study inclusion are eligible. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dysautonomia | Other | Indicators of dysautonomia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate variability | Heart rate variability will be measured using a 2-lead ECG. | The change between baseline, 3 months (primary time endpoint), 6 months and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Electrodermal activity | Electrodermal activity will be measured by applying two skin conductance sensors. | The change between baseline, 3 months (primary time endpoint), 6 months and 12 months |
| Respiration rate |
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Inclusion Criteria:
Exclusion Criteria:
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Male and female patients who were previously infected with covid-19.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marc Schiltz, MD | Contact | +32 2 477 60 20 | marc.schiltz@uzbrussel.be |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitair Ziekenhuis Brussel | Recruiting | Jette | Brussels Capital | 1090 | Belgium |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Respiration will be measured using a respiration sensor (an elastic belt) .
| The change between baseline, 3 months (primary time endpoint), 6 months and 12 months |
| Blood volume pulse | The blood volume pulse sensor uses fingertip photo plethysmography. | The change between baseline, 3 months (primary time endpoint), 6 months and 12 months |
| Functionality and disability | Functional status will be evaluated by the Post-COVID-19 Functional Status Scale. | The change between baseline, 3 months (primary time endpoint), 6 months and 12 months |
| Functionality and disability | Level of dyspnea during activities of daily living will be evaluated by the London chest Activity of Daily Living scale. | The change between baseline, 3 months (primary time endpoint), 6 months and 12 months |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |