Yoga Pranayama Adjuvant to Treat Burden COVID-19

NCT04413747 | Unknown DMC

• 1 other identifier: 2020_COVID-19_YOGA
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronavirus Infection; Cytokine Storm; Mental Disorder

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Mortality

  COVID-19's Patients mortality all cause: incidence proportion.

  12 months.

• Mortality-suicide

  COVID-19's Patients suicide: incidence proportion.

  12 months.

Secondary Outcomes (4)

• Incidence of hospitalization for respiratory failure of COVID-19's Patients-

  1 months.

• Incidence of al home professional psychiatric-psychological interventions for mental disorder.

  12 months.

• Incidence of mental disorder: Beck Depression Inventory-Second Edition (BDI-II).

  12 months.

• Incidence od spleep disorder:Pittsburgh Sleep Quality Index (PSQI).

  12 months.

Study Arms (1)

Yoga-based breathing support

EXPERIMENTAL

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; Behavioral: pre_lunch Yoga-based breathing support; Behavioral: pre_dinner Yoga-based breathing support

Interventions

morning Yoga-based breathing support BEHAVIORAL

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.

Also known as: First procedure

Yoga-based breathing support

pre_lunch Yoga-based breathing support BEHAVIORAL

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.

Also known as: Second procedure

Yoga-based breathing support

pre_dinner Yoga-based breathing support BEHAVIORAL

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.

Also known as: Third procedure

Yoga-based breathing support

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Ambulatorio Telemedicina Giardino St Lucia

Massa Lombarda, Ravenna, 48024, Italy

Location

Related Publications (9)

• Wenham C, Smith J, Morgan R; Gender and COVID-19 Working Group. COVID-19: the gendered impacts of the outbreak. Lancet. 2020 Mar 14;395(10227):846-848. doi: 10.1016/S0140-6736(20)30526-2. Epub 2020 Mar 6. No abstract available.

  PMID: 32151325 BACKGROUND

• Johansson PI, Stensballe J, Ostrowski SR. Shock induced endotheliopathy (SHINE) in acute critical illness - a unifying pathophysiologic mechanism. Crit Care. 2017 Feb 9;21(1):25. doi: 10.1186/s13054-017-1605-5.

  PMID: 28179016 BACKGROUND

• Borovikova LV, Ivanova S, Zhang M, Yang H, Botchkina GI, Watkins LR, Wang H, Abumrad N, Eaton JW, Tracey KJ. Vagus nerve stimulation attenuates the systemic inflammatory response to endotoxin. Nature. 2000 May 25;405(6785):458-62. doi: 10.1038/35013070.

  PMID: 10839541 BACKGROUND

• Koopman FA, Chavan SS, Miljko S, Grazio S, Sokolovic S, Schuurman PR, Mehta AD, Levine YA, Faltys M, Zitnik R, Tracey KJ, Tak PP. Vagus nerve stimulation inhibits cytokine production and attenuates disease severity in rheumatoid arthritis. Proc Natl Acad Sci U S A. 2016 Jul 19;113(29):8284-9. doi: 10.1073/pnas.1605635113. Epub 2016 Jul 5.

  PMID: 27382171 BACKGROUND

• Thayer JF, Sternberg EM. Neural aspects of immunomodulation: focus on the vagus nerve. Brain Behav Immun. 2010 Nov;24(8):1223-8. doi: 10.1016/j.bbi.2010.07.247. Epub 2010 Jul 30.

  PMID: 20674737 BACKGROUND

• Lv H, Zhao YH, Chen JG, Wang DY, Chen H. Vagus Nerve Stimulation for Depression: A Systematic Review. Front Psychol. 2019 Jan 31;10:64. doi: 10.3389/fpsyg.2019.00064. eCollection 2019.

  PMID: 30766497 BACKGROUND

• O'Reardon JP, Cristancho P, Peshek AD. Vagus Nerve Stimulation (VNS) and Treatment of Depression: To the Brainstem and Beyond. Psychiatry (Edgmont). 2006 May;3(5):54-63.

  PMID: 21103178 BACKGROUND

• Jordana J, Trivino-Salazar JC. Where are the ECDC and the EU-wide responses in the COVID-19 pandemic? Lancet. 2020 May 23;395(10237):1611-1612. doi: 10.1016/S0140-6736(20)31132-6. Epub 2020 May 13. No abstract available.

  PMID: 32410757 BACKGROUND

• Zhu S, Wu Y, Zhu CY, Hong WC, Yu ZX, Chen ZK, Chen ZL, Jiang DG, Wang YG. The immediate mental health impacts of the COVID-19 pandemic among people with or without quarantine managements. Brain Behav Immun. 2020 Jul;87:56-58. doi: 10.1016/j.bbi.2020.04.045. Epub 2020 Apr 18.

  PMID: 32315758 BACKGROUND

MeSH Terms

Conditions

Coronavirus Infections; Cytokine Release Syndrome; Mental Disorders; COVID-19

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Nagarathna Raghuram, MD

  Vivekananda Yoga Anusandhana Samsthana, Bengaluru, India

  PRINCIPAL INVESTIGATOR

• HR Nagendra., Eng

  Vivekananda Yoga Anusandhana Samsthana, Bengaluru, India

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

• Maria Luisa Vitobello

  EJTN GEIE, Brussellese, Belgium

  STUDY DIRECTOR

• Luca Ghetti, Eng.

  Halnet Srl

  STUDY DIRECTOR

• Fabio Zucchetta, MD

  Casa di Riposo Giardino St Lucia, Massa Lombarda (Ra) Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giorgio Noera, MD, PhD

CONTACT

+393358294727; presidenza@healthricercaesviluppo.it

Boris Bazzani, ERYT

CONTACT

+393384841931; amministrazione@fbiteam.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: identifier number (ID) without any refer to clinical assessment or to patients
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: June 4, 2020
• Study Start: August 15, 2020
• Primary Completion: June 1, 2021
• Study Completion: September 30, 2021
• Last Updated: August 7, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 18 months
• Access Criteria: ID (nikname ) and password

Locations

IT (1)