| CTRI Number |
CTRI/2021/09/036829 [Registered on: 24/09/2021] Trial Registered Prospectively |
| Last Modified On: |
22/09/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Yoga for lung functions in COVID-19 survivors |
|
Scientific Title of Study
|
Effect of Yoga-based Rehabilitation on pulmonary function in COVID-19 survivors with respiratory sequelae: A PROBE trial |
| Trial Acronym |
Re-Cover |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Randeep Guleria |
| Designation |
Director |
| Affiliation |
AIIMS, New Delhi |
| Address |
Director Office, AIIMS, New Delhi
Director Office, AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9810184738 |
| Fax |
|
| Email |
randeepguleria2002@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Randeep Guleria |
| Designation |
Director |
| Affiliation |
AIIMS, New Delhi |
| Address |
Director Office, AIIMS, New Delhi
Director Office, AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9810184738 |
| Fax |
|
| Email |
randeepguleria2002@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Randeep Guleria |
| Designation |
Director |
| Affiliation |
AIIMS, New Delhi |
| Address |
Director Office, AIIMS, New Delhi
Director Office, AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9810184738 |
| Fax |
|
| Email |
randeepguleria2002@yahoo.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, New Delhi. |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Ansari Nagar, New Delhi-110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Randeep Guleria |
All India Institute of Medical Science |
Ansari Nagar, New Delhi
New Delhi
DELHI |
9911110487
randeepguleria2002@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee,AIIMS New Delhi-110029 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard Care |
Standard care provided by the treating physican at AIIMS, New Delhi |
| Intervention |
Yoga Based Rehabilitation including loosening exercises, breathing exercises, asanas, pranayama and guided relaxation |
First 3 sessions will be contact session with in the first week of recruitment at CIMR following online session, twice a week for12 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
a)Known case of COVID patients with respiratory symptoms on screening (RT-PCR negative or 4 weeks to 8 weeks from the onset of first symptom)
b)Patients with forced vital capacity(FVC)<80%
c)Patients of both sex and age of18-75years
d)Patients who are able and willing to practice any form of exercise when recruited under the study
e)Patients who are not engaged in regular and structured yoga practice.
|
|
| ExclusionCriteria |
| Details |
a)Patients with forced vital capacity FVC<40 %
b)Previous pulmonary complications like severe asthma, COPD, bronchiectasis, interstitial lung disease(IL)
c)Known cases of CAD with moderate to severe LV dysfunction, patients with a history of CV or neurodegenerative diseases.
d)Lactating and pregnant women.
e)Patients currently participating in any other clinical trials with intervention. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pulmonary Function: Diffusion lung capacity for carbon monoxide (DLCO), Forced Vital capacity (FVC), Forced expiratory volume in first second (FEV1), Total lung capacity (TLC) using Pulmonary function test |
Baseline, after 6 weeks and at the end of 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Severity of dyspnea using UCSD Shortness of Breath Questionnaire.
Exercise capacity using 6-minute walk test
Inflammatory markers such as Interleukin-6(IL-6) and C-reactive protein (CRP).
Total severity score, presence of significant extension of fibrotic abnormalities, ground glass
Opacities (GGO) and consolidation, lobar distribution and linear opacities using HRCT of lungs Psychological assessment using general Anxiety Disorder-7(GAD-7), Patient Health Questionaire9 (PHQ-9)
Health related quality of life (QOL) using short form (SF-36) |
Baseline, after 6 weeks and at the end of 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
30/11/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Coronavirus disease recovered cases reveal the varying degrees of radiological abnormalities associated with the deterioration of the pulmonary function which could manifest in a cascade of cardiopulmonary consequences and abnormal lung function. Also, unprecedented change, fear, and uncertainty during the COVID era has implicated in emotional distress, psychosocial dysfunction, and a surge of mental health problems. Yoga improvement in pulmonary function, rehabilitation, Health-Related Quality of Life and reduces Anxiety & Depression, several types of research have demonstrated the benefits of yoga. The current study attempts to explore yoga-based rehabilitation using a validated and customized yoga module. Keeping this in consideration, a randomized controlled open-label, endpoint blind, a clinical trial is planned to evaluate Yoga therapy as an add-on to standard care in Post covid patients.The proposed study design is a prospective randomized open label blinded endpoint trial with 1:1 allocation ratio. The study participant may fall into the intervention arm will give Yoga for 30 mint for 12 weeks.outcome measures on Baseline, after 6 weeks and at the end of 12 weeks of study. |