Yoga program on COVID 19 patients

Completed

Conditions: Coronavirus as the cause of diseases classified elsewhere,

Registration Number: CTRI/2020/11/028827

Lead Sponsor: Central Council for Research in Yoga and Naturopathy Ministry of AYUSH

Brief Summary: *The anxiety and uncertainty about the trajectory and course of illness among the Covid 19 positive patients can lead to psychologic distress that can down regulate their immune defenses and increase the chance and severity of infection. Studies have shown psychologic stress to enhance the rates of infection in communities during a flu season**. Studies have also shown mind body interventions such as exercise*()*, meditation and yoga**to reduce infection rates in communities during a seasonal flu. Experience from China has shown that* providing psychological treatment and support may reduce the burden of comorbid mental health conditions and ensure the wellbeing of those affected). However, Covid 19 is highly infectious warranting isolation of the patient. In this study we will test the efficacy of a mobile app based yoga intervention along with non-obtrusive and non-contact monitoring of patientâ€™s vitals using a novel sensor technology (dozee) developed by IITians to measure vitals, psychologic distress and relaxation response. This is achieved through a sensor mat that is placed below the patientâ€™s mattress. We will evaluate the role of yoga intervention (pranayama and relaxation) in reducing symptom scores, self-reported stress, mood and quality of life. We will also assess if yoga intervention helped reduce stress (using heart rate variability), improve sleep and vitals in this population. T

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 86

Inclusion Criteria

1.Covid 19 positive case diagnosed using RT PCR in authorized Covid19 testing facility 2.Mild clinical presentation (identified at the time of admission to ward by National Early Warning Score NEWS-2; mild 0-4; severe 5-6) 3.Presenting with or without flu symptoms 4.Aged 18-60 years 5.High school education 6.Written consent to participate in any arm of the study 7.Those having a smart phone mobile device with android or IOS operating system.

Exclusion Criteria

1.Severe infection News-3-4 requiring admission to ICU.
2.Unable to take oral medication, 3.Immunocompromised, 4.Creatinine clearance (CCL) < 30 ml/min, 5.Aspartate transaminase (AST) or alanine transaminase (ALT) > 5 times Upper limit of normal (ULN), 6.d-dimer > 2microgram per liter, or 7.Uncontrolled diabetes, Hypertension, Existing Heart disease and heart failure, any cancer, autoimmune disease, stroke, neurodegenerative diseases etc..
8.Clinical condition that reduces survival to less than six months.
9.Pregnancy and lactating mothers 10.Clinical signs suggestive of septicemia and multi organ dysfunction.
11.Score of less than 24 points on the Folstein Mini-Mental State Examination(43).
12.Score of more than 14 points on the 9-item Patient Health Questionnaire (PHQ-9) depression screen (44).
13.BMI less than 18.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome will be defined as area-under-the curve global severity for all ARI illness days throughout observation, from consent to study exit	Day 0 to study exit

Secondary Outcome Measures

Name	Time	Method
1.Time to discharge/recovery: Discharge/recovery, ICU admissions and Death will be considered events. Time to event analysis will be carried out as one of the outcomes. Will be a study endpoint.	2.Biomarkers: With each ARI illness episode, a nasal wash /throat swab will be collected in VTB medium within 3 days of symptom onset and analyzed for covid 19 using Multiplex polymerase chain reaction (PCR) This test will be done at baseline and 14 days.

Trial Locations

Locations (6): AIIMS, New Delhi
🇮🇳
Delhi, DELHI, India
AIIMS, Rishikesh
🇮🇳
Hardwar, UTTARANCHAL, India
Chinmaya Mission Hospital
🇮🇳
Bangalore, KARNATAKA, India
Dr Ram Manohar Lohia Hospital
🇮🇳
Central, DELHI, India
Lady Hardinge Medical College and Hospital
🇮🇳
Central, DELHI, India
Rajiv Gandhi Super Speciality Hospital
🇮🇳
South, DELHI, India
AIIMS, New Delhi
🇮🇳Delhi, DELHI, India
Dr Deepak KK
Principal investigator
8368293571
kkdeepak@gmail.com