Yoga Pranayama Adjuvant to Treat Burden COVID-19 (YOCO)
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ClinicalTrials.gov Identifier: NCT04413747 |
Recruitment Status :
Not yet recruiting
First Posted : June 4, 2020
Last Update Posted : August 7, 2020
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Condition or disease | Intervention/treatment | Phase |
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Coronavirus Infection Cytokine Storm Mental Disorder | Behavioral: morning Yoga-based breathing support Behavioral: pre_lunch Yoga-based breathing support Behavioral: pre_dinner Yoga-based breathing support | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 1000 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
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 |
Masking: | None (Open Label) |
Masking Description: | identifier number (ID) without any refer to clinical assessment or to patients |
Primary Purpose: | Supportive Care |
Official Title: | Yoga- Based Breathing for Vagus Nerve Stimulation as Home-care Adjuvant Treatment Against Burden COVID-19 |
Estimated Study Start Date : | August 15, 2020 |
Estimated Primary Completion Date : | June 1, 2021 |
Estimated Study Completion Date : | September 30, 2021 |

Arm | Intervention/treatment |
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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)
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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 Name: 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 Name: 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 Name: Third procedure |
- Mortality [ Time Frame: 12 months. ]COVID-19's Patients mortality all cause: incidence proportion.
- Mortality-suicide [ Time Frame: 12 months. ]COVID-19's Patients suicide: incidence proportion.
- 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 -
- 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.
- 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.
- 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.

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04413747
Contact: Giorgio Noera, MD, PhD | +393358294727 | presidenza@healthricercaesviluppo.it | |
Contact: Boris Bazzani, ERYT | +393384841931 | amministrazione@fbiteam.it |
Italy | |
Ambulatorio Telemedicina Giardino St Lucia | |
Massa Lombarda, Ravenna, Italy, 48024 | |
Contact: Morena Gaddoni +39054581871 direzione@giardinostlucia.it |
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:
Responsible Party: | Health Ricerca e Sviluppo S.R.L. |
ClinicalTrials.gov Identifier: | NCT04413747 |
Other Study ID Numbers: |
2020_COVID-19_YOGA |
First Posted: | June 4, 2020 Key Record Dates |
Last Update Posted: | August 7, 2020 |
Last Verified: | August 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | The datasets generated during and/or analysed during the current study will be available upon request within a web_ client structure |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code |
Time Frame: | 18 months |
Access Criteria: | ID (nikname ) and password |
URL: | https://ifc.cnr.it |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 CYTOKINE STORM MEDICAL YOGA PRANAYAMA VAGUS NERVE STIMOLATION MENTAL DISORDER |
Coronavirus Infections Severe Acute Respiratory Syndrome Mental Disorders Psychotic Disorders Coronaviridae Infections Nidovirales Infections |
RNA Virus Infections Virus Diseases Schizophrenia Spectrum and Other Psychotic Disorders Respiratory Tract Infections Respiratory Tract Diseases |