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

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

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

Study Overview

• Status: Completed
• Conditions: Post-COVID-19 Syndrome
• Intervention / Treatment: Device: non-invasive auricular vagus stimulation; Device: Placebo Non Invasive Vagus Stimulation

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 Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul Avrupa Kitasi
    • Istanbul, Istanbul Avrupa Kitasi, Turkey, 34353
      • Bahcesehir University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Istanbul Medipol University Hospital

Publications and helpful links

General Publications

• McNarry MA, Berg RMG, Shelley J, Hudson J, Saynor ZL, Duckers J, Lewis K, Davies GA, Mackintosh KA. Inspiratory muscle training enhances recovery post-COVID-19: a randomised controlled trial. Eur Respir J. 2022 Oct 6;60(4):2103101. doi: 10.1183/13993003.03101-2021. Print 2022 Oct.

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2023
• Primary Completion (Actual): March 9, 2023
• Study Completion (Actual): August 4, 2023

Study Registration Dates

• First Submitted: March 9, 2023
• First Submitted That Met QC Criteria: March 9, 2023
• First Posted (Actual): March 10, 2023

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 9, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: SARS-CoV-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No