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Yoga Pranayama Adjuvant to Treat Burden COVID-19

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04413747
Acronym
YOCO
Enrollment
1000
Registered
2020-06-04
Start date
2020-08-15
Completion date
2021-09-30
Last updated
2020-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronavirus Infection, Cytokine Storm, Mental Disorder

Keywords

COVID-19, CYTOKINE STORM, MEDICAL YOGA PRANAYAMA, VAGUS NERVE STIMOLATION, MENTAL DISORDER

Brief summary

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.

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.

Interventions

BEHAVIORALmorning 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.

BEHAVIORALpre_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.

BEHAVIORALpre_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.

Sponsors

Swami Vivekananda Yoga Anusandhana Samsthana, Bangaluru , India
CollaboratorUNKNOWN
Yoga Experience Association,Cervia (Ra), Italy
CollaboratorUNKNOWN
EJTN GEIE, Brussellese, Belgium
CollaboratorUNKNOWN
Casa di Riposo e Ambulatorio Giardino St Lucia, Massa Lomabarda (Ra) Italy
CollaboratorUNKNOWN
Halnet Srl, Faenza (Ra), Italy
CollaboratorUNKNOWN
Health Ricerca e Sviluppo S.R.L.
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Masking description

identifier number (ID) without any refer to clinical assessment or to patients

Intervention model description

Prospective cohort study based on clinical assessment. Model- based adjusted outcome via hierarchical comparison of control curves using COVID19 national epidemic data with cyber layer algorithm of population

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Mortality12 months.COVID-19's Patients mortality all cause: incidence proportion.
Mortality-suicide12 months.COVID-19's Patients suicide: incidence proportion.

Secondary

MeasureTime frameDescription
Incidence of hospitalization for respiratory failure of COVID-19's Patients-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 -
Incidence of al home professional psychiatric-psychological interventions for mental disorder.12 months.Homecare interventions for anxiety and depression requiring drugs treatment: incidence proportion.
Incidence of mental disorder: Beck Depression Inventory-Second Edition (BDI-II).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.
Incidence od spleep disorder:Pittsburgh Sleep Quality Index (PSQI).12 months.Scoring system for sleep disorders requiring drugs treatment: incidence proportion of aggregate PSQI score 0-21 (worse outcome) , cutoff \> 8.

Countries

Italy

Contacts

Primary ContactGiorgio Noera, MD, PhD
presidenza@healthricercaesviluppo.it+393358294727
Backup ContactBoris Bazzani, ERYT
amministrazione@fbiteam.it+393384841931

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026