Yoga Pranayama Adjuvant to Treat Burden COVID-19 (YOCO)

August 5, 2020 updated by: Health Ricerca e Sviluppo S.R.L.

Yoga- Based Breathing for Vagus Nerve Stimulation as Home-care Adjuvant Treatment Against Burden COVID-19

COronaVIrus Disease or Severe Acute Respiratory Syndrome -CoV-2 or COVID-19, mortality occurs mainly from immunological behavior or by suicide after healing . In both cases, the causal link is coronavirus within the host response. The rationale of use of deep yoga breathing as adjuvant treatment to COVID-19 disease , is linked to the mechanical action to stimulate the vagus nerve through scalene and sternocleidomastoid muscles function of which the continuity of action bring to modulate upto suppress, the inflammatory reflex and pro-inflammatory cytokines overproduction and contextual lowering of the sympathetic stress response as a first cause of sleep and late mental disorders which can increase the annual suicide rate. An easily breathing medical Yoga protocol has been developed to test a cost-effective care provision, training, contact tracing and mass efficacy testing.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

COronaVIrus Disease or Severe Acute Respiratory Syndrome -CoV-2 or COVID-19, pandemic threatens patients, societies and healthcare systems around the world. Morbidity and lethality have a direct link with the early vicious circles triggered by an acute microcirculation endotheliopathy, a correlated coagulopathy, up to late hypoxic damage of multi organ tissue The host immunity determines the progress of the disease , its lethality and the need of care intensity. The clinical course of the infection consist of three stage of which only the third -which intervenes in a low incidence of patients - need of hospitalization for severe hyperinflammatory syndrome including acute respiratory failure, while first and the second or moderate pulmonary involvement, might manage and monitoring within a homecare program during quarantine. Actually, the rough mortality in Italy is - at the current date - 7.6 % with an expected death of 0.004 of the whole population. The late lethality - still little known - from COVID-19 is to be correlated with mental disorders from stress response emerging from the first three COVID-19's stages and which result in a significant increase in suicides that is estimated at 30% more than expected of 7.4 deaths for 100,000 residents. This estimate can be considered as stage 4 of the disease or post COVID-19 mortality. In this scenario, mortality of COVID-19 is by intensity response of "the host " and in the meantime, a cutoff for homecare, hospitalization and time-related stress disease. Lines of evidence reports that direct-indirect stimulation of vagus nerve bring to the modulating of pro-inflammatory cytokines with effective systemic anti-inflammatory effect and has shown antidepressant effects in chronic treatment resistant depression. Because the vagus nerve is linked to brain regions important in anxiety regulation (locus coeruleus, orbitofrontal cortex, insula, hippocampus and amygdala), this pathway is involved in perceiving various somatic and cognitive symptoms that characterize anxiety and mental disorder disorders. On the basis of all these reasoning we plan to introduce a medical based-yoga deep breathing for activation of vagus nerve by scalene and sternocleidomastoid muscles function during breathing, as an adjuvant of care of the 1-2 and 4 stages of the COVID-19 disease to counteract the cumulative incidence of mortality and better outcome. Medical yoga protocol has been developed and designed to test a cost-effective care provision, training, contact tracing and mass efficacy testing.

Study Type

Interventional

Enrollment (Anticipated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • Ravenna
      • Massa Lombarda, Ravenna, Italy, 48024

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participant is willing and able to give informed consent for participation in the trial;
  • Male or Female, aged 18 years or above;
  • Diagnosed COVID-19's infection;
  • Informed consent;
  • Having been diagnosed in the last 1 week;
  • In the Investigator's opinion, is able and willing to comply with all trial requirements;
  • Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the trial;
  • Patients who continue to be followed at home.

Exclusion Criteria:

The participant may not enter the trial if ANY of the following apply:

  • No informed consent;
  • Participant is not willing and able to give informed consent for participation in the trial;
  • Female participant who is pregnant, lactating or planning pregnancy during the course of the trial;
  • Hospitalization patients;
  • Having a serious cognitive impairment;
  • Having serious hearing and vision problems;
  • Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial;
  • Participants who have participated in another research trial involving an investigational product in the past 12 weeks.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Yoga-based breathing support
Three daily yoga pranayama breathing cycles within existing home-care provision of Covid19's patients (protocols shared dated 27 March 2020 by Italian Society of Infectious and Tropical Diseases - Italian General Practitioners Physician - Italian Society of General Medicine, Italy)
Behavioral: morning Yoga-based breathing support
Low and deep inspiration and phonetic syllable OM laryngeal vibration ( OM technique) as expiratory exercises, sitting in easy pose. The length of more than 5 -8 sec. and frequency between 20 and 23 breaths /min. Conscious breath number (n°) of 15 respiratory acts (RAc) and OM technique n° of 5 RAc and Bhramari pranayama n° of 5 RAc.
Other Names:
  • First procedure
Behavioral: pre_lunch Yoga-based breathing support
Low and deep inspiration and OM technique as expiratory exercises, sitting in easy pose.The length of more than 5 -8 sec. and frequency between 20 and 23 breaths /min. Conscious breath number (n°) of 15 respiratory acts (RAc) and OM technique n° of 5 RAc and Surya Bheda pranayama n° of 5 RAc.
Other Names:
  • Second procedure
Behavioral: pre_dinner Yoga-based breathing support
Low and deep inspiration and OM technique as expiratory exercises, sitting in easy pose.The length of more than 5 -8 sec. and frequency between 20 and 23 breaths /min. Conscious breath number (n°) of 15 respiratory acts (RAc) and OM technique n° of 5 RAc and Nadi Shodhana pranayama n° of 5 RAc.
Other Names:
  • Third procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 12 months.
COVID-19's Patients mortality all cause: incidence proportion.
12 months.
Mortality-suicide
Time Frame: 12 months.
COVID-19's Patients suicide: incidence proportion.
12 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of hospitalization for respiratory failure of COVID-19's Patients-
Time Frame: 1 months.
In-hospital COVID-19's Patients oxygen invasive ventilation or high flow oxygen devices :incidence proportion of Brescia COVID-19 respiratory Severity Scale Index (Levels 0-3 worse outcome) cutoff Level ≥ 2 -
1 months.
Incidence of al home professional psychiatric-psychological interventions for mental disorder.
Time Frame: 12 months.
Homecare interventions for anxiety and depression requiring drugs treatment: incidence proportion.
12 months.
Incidence of mental disorder: Beck Depression Inventory-Second Edition (BDI-II).
Time Frame: 12 months.
Scoring system for depression and anxiety requiring drugs treatment: incidence proportion of BDI-II aggregate components score 0- 63 ( worse outcome) , cutoff > 29.
12 months.
Incidence od spleep disorder:Pittsburgh Sleep Quality Index (PSQI).
Time Frame: 12 months.
Scoring system for sleep disorders requiring drugs treatment: incidence proportion of aggregate PSQI score 0-21 (worse outcome) , cutoff > 8.
12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Health Ricerca e Sviluppo S.R.L.

Collaborators

Swami Vivekananda Yoga Anusandhana Samsthana, Bangaluru , India
Yoga Experience Association,Cervia (Ra), Italy
EJTN GEIE, Brussellese, Belgium
Casa di Riposo e Ambulatorio Giardino St Lucia, Massa Lomabarda (Ra) Italy
Halnet Srl, Faenza (Ra), Italy

Investigators

  • Principal Investigator: Nagarathna Raghuram, MD, Vivekananda Yoga Anusandhana Samsthana, Bengaluru, India
  • Study Chair: HR Nagendra., Eng, Vivekananda Yoga Anusandhana Samsthana, Bengaluru, India
  • Principal Investigator: Maria Donatella Barbagallo, MD, Yoga Experience Association,Cervia (Ra), Italy
  • Principal Investigator: Enrico Ricci, MD, Yoga Experience Association,Cervia (Ra), Italy
  • Principal Investigator: Morena Gaddoni, MD, Casa di Riposo Giardino St Lucia, Massa Lombarda (Ra) Italy
  • Study Director: Maria Luisa Vitobello, EJTN GEIE, Brussellese, Belgium
  • Study Director: Luca Ghetti, Eng., Halnet Srl
  • Principal Investigator: Fabio Zucchetta, MD, Casa di Riposo Giardino St Lucia, Massa Lombarda (Ra) Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 15, 2020

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

September 30, 2021

Study Registration Dates

First Submitted

May 29, 2020

First Submitted That Met QC Criteria

June 2, 2020

First Posted (Actual)

June 4, 2020

Study Record Updates

Last Update Posted (Actual)

August 7, 2020

Last Update Submitted That Met QC Criteria

August 5, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020_COVID-19_YOGA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

The datasets generated during and/or analysed during the current study will be available upon request within a web_ client structure

IPD Sharing Time Frame

18 months

IPD Sharing Access Criteria

ID (nikname ) and password

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Study Data/Documents

  1. Study Protocol
    Information identifier: guest_1
  2. Informed Consent Form
    Information identifier: guest_2
  3. Individual Participant Data Set
    Information identifier: guest_3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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