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

Sponsor
Istanbul Medipol University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05764070
Collaborator
(none)
46
Enrollment
1
Location
2
Arms
2.2
Anticipated Duration (Months)
20.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: non-invasive auricular vagus stimulation
  • Device: Placebo Non Invasive Vagus Stimulation
 N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
46 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Masking Description:
Evaluation and treatment will be carried out by different physiotherapists.
Primary Purpose:
Treatment
Official Title:
Impact of Vagus Nerve Stimulation on Post-Aerobic Activity Recovery in Post Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Patients
Actual Study Start Date :
Mar 9, 2023
Anticipated Primary Completion Date :
Mar 9, 2023
Anticipated Study Completion Date :
May 16, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Non Invasive Vagus Stimulation

Aerobic exercise + Non Invasive- Vagus Stimulation

Device: non-invasive auricular vagus stimulation
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.
Placebo Comparator: Placebo Non Invasive Vagus Stimulation

Aerobic exercise + Placebo Non Invasive Vagus Stimulation

Device: Placebo Non Invasive Vagus Stimulation
Placebo Non Invasive Vagus Stimulation

Outcome Measures

Primary Outcome Measures

  1. Visual Analogue Scale (VAS) [a day]

    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.

  2. Autonomic nervous system device (Polar H10) [a day]

    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.

  3. Lactate Analysis [one day]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bahçeşehir University Istanbul Istanbul Avrupa Kitasi Turkey 34353

Sponsors and Collaborators

  • Istanbul Medipol University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
hazal genc, physiotherapist PhD, Istanbul Medipol University Hospital
ClinicalTrials.gov Identifier:
NCT05764070
Other Study ID Numbers:
  • SARS-CoV-2
First Posted:
Mar 10, 2023
Last Update Posted:
Mar 14, 2023
Last Verified:
Mar 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Syndrome

Study Results

No Results Posted as of Mar 14, 2023