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

NCT ID: NCT05764070

Last Updated: 2023-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-09

Study Completion Date

2023-08-04

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.

Conditions

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Post-COVID-19 Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
Evaluation and treatment will be carried out by different physiotherapists.

Study Groups

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Non Invasive Vagus Stimulation

Aerobic exercise + Non Invasive- Vagus Stimulation

Group Type EXPERIMENTAL

non-invasive auricular vagus stimulation

Intervention Type DEVICE

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 Non Invasive Vagus Stimulation

Aerobic exercise + Placebo Non Invasive Vagus Stimulation

Group Type PLACEBO_COMPARATOR

Placebo Non Invasive Vagus Stimulation

Intervention Type DEVICE

Placebo Non Invasive Vagus Stimulation

Interventions

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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.

Intervention Type DEVICE

Placebo Non Invasive Vagus Stimulation

Placebo Non Invasive Vagus Stimulation

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul Medipol University Hospital

OTHER

Sponsor Role lead

Responsible Party

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hazal genc

physiotherapist PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Bahçeşehir University

Istanbul, Istanbul Avrupa Kitasi, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 35236727 (View on PubMed)

Other Identifiers

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SARS-CoV-2

Identifier Type: -

Identifier Source: org_study_id

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