Impact of Vagus Nerve Stimulation on Post-Aerobic Activity Recovery in Post SARS-CoV-2 Patients

Study Overview
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Brief Summary
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Chronic fatigue, weakness, dyspnea, headaches, cognitive dysfunction, stress, sadness, anxiety, sleep disturbances, and orthostatic intolerance are among the symptoms of acute Covid-19 in patients, and these symptoms persist for more than 12 weeks after recovery. Extended Covid-19 syndrome, also known as Post-Covid-19 syndrome, is described as

Detailed Description
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Therapeutic exercises are an evidence-based method for the maintenance of musculoskeletal, cardiovascular and neurological well-being and the prevention and treatment of chronic diseases. The effects of therapeutic exercises on the human body varied according to the frequency, intensity, duration and type of exercise. Increasing physiological and psychological recovery after exercise can lead to results such as better performance and reducing the risk of injury. Therefore, various methods are used to facilitate post-exercise recovery. The best-known and most widely used post-exercise recovery method is active cooling, also known as active rest or cool-down. Active cooling; It is defined as any activity that includes voluntary, low/moderate intensity exercise or movement performed within one hour of exercise. Passive rest, on the other hand, is defined as no or minimal voluntary/intentional exercise movement.

Official Title
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Impact of Vagus Nerve Stimulation on Post-Aerobic Activity Recovery in Post Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Patients

Conditions
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Post-COVID-19 Syndrome

Intervention / Treatment
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* Device: non-invasive auricular vagus stimulation
* Device: Placebo Non Invasive Vagus Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Covid be between 18-45 years old Having pulmonary involvement in the covid process Exclusion criteria: Being a professional in any sport Having a cardiopulmonary, orthopedic, neurological and metabolic disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Non Invasive Vagus Stimulation<br>Aerobic exercise + Non Invasive- Vagus Stimulation | Device: non-invasive auricular vagus stimulation<br>* The only cutaneous nerve of the N. vagus, ramus auricularis, receives sensation from the posterior surface of the auricle, the posterior part of the external auditory canal and the adjacent part of the eardrum. Non-invasive transcutaneous devices stimulate the vagus nerve via the auricular route or from the carotid. This device non-invasively stimulates the auricular branch of the vagus nerve without any action. As a result, it was found that the pain threshold increased and the mechanical pain sensitivity decreased.<br>|
| Placebo Comparator: Placebo Non Invasive Vagus Stimulation<br>Aerobic exercise + Placebo Non Invasive Vagus Stimulation | Device: Placebo Non Invasive Vagus Stimulation<br>* Placebo Non Invasive Vagus Stimulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale (VAS) | In the measurement of pain intensity, it was planned to use a standard, 10 mm VAS with proven reliability. The severity of pain felt by the patient; It is a scale used to mark 0 = no pain and 10 = the most severe pain, thus determining the patient's pain intensity subjectively. | a day | 
| Autonomic nervous system device (Polar H10) | The Polar H10 device is a heart rate sensor that comes with a wearable chest strap and is the gold standard of high sensitivity and accuracy. It can be connected to multiple training devices via Bluetooth and ANT+. The device comes with a soft, adjustable sensor that touches the chest to capture the heart rate in real time. In the study, the autonomic nervous system will be evaluated with the Polar H10 device. By connecting the device to a smart phone via bluetooth, the data will be recorded and the software supported by the device will be used for the analysis of the data. | a day | 
| Lactate Analysis | It was measured with a portable lactate analyzer before and after exercise training, just before the recovery phase. It is an ideal lactate analyzer for using metabolic information to assess endurance, design optimal training programs, avoid overtraining plans and help identify target heart rate zones. | one day |