NCT05764070

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

March 9, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 10, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 4, 2023

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

Same day

First QC Date

March 9, 2023

Last Update Submit

August 9, 2023

Conditions

Post-COVID-19 Syndrome

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

Non Invasive Vagus Stimulation

EXPERIMENTAL

Aerobic exercise + Non Invasive- Vagus Stimulation

Device: non-invasive auricular vagus stimulation

Placebo Non Invasive Vagus Stimulation

PLACEBO COMPARATOR

Aerobic exercise + Placebo Non Invasive Vagus Stimulation

Device: Placebo Non Invasive Vagus Stimulation

Interventions

non-invasive auricular vagus stimulationDEVICE

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.

Non Invasive Vagus Stimulation
Placebo Non Invasive Vagus StimulationDEVICE

Placebo Non Invasive Vagus Stimulation

Placebo Non Invasive Vagus Stimulation

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Covid
  • be between 18-45 years old
  • Having pulmonary involvement in the covid process

You may not qualify if:

  • Being a professional in any sport
  • Having a cardiopulmonary, orthopedic, neurological and metabolic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahçeşehir University

Istanbul, Istanbul Avrupa Kitasi, 34353, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 35236727BACKGROUND

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Evaluation and treatment will be carried out by different physiotherapists.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physiotherapist PhD

Study Record Dates

First Submitted

March 9, 2023

First Posted

March 10, 2023

Study Start

March 9, 2023

Primary Completion

March 9, 2023

Study Completion

August 4, 2023

Last Updated

August 14, 2023

Record last verified: 2023-08

Locations

TU(1)