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Clinical Trial Details (PDF Generation Date :- Mon, 27 Sep 2021 15:11:06 GMT)

CTRI Number CTRI/2021/02/031322 [Registered on: 16/02/2021] - Trial Registered Prospectively Last Modified On 15/02/2021 Post Graduate Thesis Yes Type of Trial Interventional Type of Study Physiotherapy (Not Including YOGA) Study Design Other Public Title of Study Study of Effectiveness of Telemedicine Based Pulmonary Rehabilitation in Recovered patients of Covid 19 Lung Infection Scientific Title of STUDY OF EFFECTIVENESS OF TELEMEDICINE BASED PULMONARY REHABILITATION IN Study RECOVERED PATIENTS OF COVID -19 PNEUMONITIS Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Dr Prageeth N P Trial Coordinator (multi-center study) Designation Post graduate first year Affiliation VMMC AND SAFDARJUNG HOSPITAL Address Room No-27 Ground floor,PMR OPD,Safdarjung Hospital New 110029 Phone 9495259334 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr R K Wadhwa Query) Designation Professor and Head of department Affiliation VMMC AND SAFDARJUNG HOSPITAL Address Room No-33 Ground floor,PMR department, OPD building, Safdarjung Hospital, South DELHI 110029 India Phone 01126164887 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr R K Wadhwa Designation Professor and Head of department Affiliation VMMC AND SAFDARJUNG HOSPITAL Address Room No-33 Ground floor,PMR department, OPD building, Safdarjung Hospital,New Delhi South DELHI 110029 India Phone 01126164887

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Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Vardhman Mahavir Medical College and Safdarjung Hospital Primary Sponsor Primary Sponsor Details Name Vardhman Mahavir Medical College and Safdarjung Hospital Address Safdarjung Hospital Ansari Nagar New Delhi-110029 Type of Sponsor Government medical college Details of Secondary Name Address Sponsor NIL NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr Prageeth N P Safdarjung Hospital Room No-27 Ground 9495259334 floor ,PMR Department New delhi 110029 [email protected] South m DELHI Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Institutional Ethics Approved 10/12/2020 No Committee Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients Coronavirus as the cause of diseases classified elsewhere Intervention / Type Name Details Comparator Agent Intervention six weeks pulmonary The initial assessment shall be rehabilitation exercise done in the physical presence of programme. the patient and the remaining 6-weeks pulmonary rehab program shall be advised and monitored through telemedicine (Video consultation/40-minute session) thrice in a week. Depending upon assessment individualized PR program shall be prescribed. The patient shall be counselled about the effect of COVID-19 on the lungs and the importance of PR program. The video call-based PR monitoring and supervised program shall be conducted thrice a week for 6 weeks. Each session shall last for 45 to 60 minutes. Each session includes breathing exercises, incentive spirometry, cough removal techniques, stretching exercises; home-based aerobic

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conditioning exercise, and strengthening exercises of upper and lower limbs. Comparator Agent NOT APPLICABALE NOT APPLICABALE Inclusion Criteria Inclusion Criteria Age From 18.00 Year(s) Age To 80.00 Year(s) Gender Both Details a. COVID-19 recovered patients (age 18-80 years) with clinical and/ radiological evidence of pneumonitis with follow up within 15 days post discharge from hospital.
b. Patient with basic smartphone and internet availability Exclusion Criteria Exclusion Criteria Details a. Pneumonitis due to other cause and clinical evidence of existing lung diseases like COPD, Interstitial lung disease b. Uncontrolled diabetes and hypertension c. Any major symptomatic illness like ischemic heart disease, chronic kidney disease d. Dementia/ Cognitive impairment or symptomatic psychiatric illness e. An impaired hearing and / or vision disability which means that the instructions are not understood Method of Generating Not Applicable Random Sequence Method of Not Applicable Concealment Blinding/Masking Not Applicable Primary Outcome Outcome Timepoints 1.reduction of dyspnea according to Modified 0 weeks and 6 weeks Medical Research Council Scale 2. reduced morbidity (physical and mental function) according to 6MWT and 30 seconds sit-to-stand test 3.improvement in the quality of life in recovered patients of COVID-19 Pneumonitis according to WHO Quality of life scale Secondary Outcome Outcome Timepoints 1.reduction of dyspnea according to Modified 6 weeks Medical Research Council Scale 2. reduced morbidity (physical and mental function) according to 6MWT and 30 seconds sit-to-stand test 3.improvement in the quality of life in recovered patients of COVID-19 Pneumonitis according to WHO Quality of life scale Target Sample Size Total Sample Size=50 Sample Size from India=50 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 N/A Date of First 16/03/2021 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=1

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Trial Months=6 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Not Yet Recruiting Trial (India) Publication Details NIL Brief Summary As a highly infectious respiratory tract disease, Corona virus disease 2019 can cause respiratory, physical, and psychological ailments in patients affected by the virus. The disease is classified under Coronavirus and named COVID-19 by World Health Organisation on 11th Feb 2020. Approximately 15% of individuals with COVID-19 develop moderate to severe disease and require hospitalization coupled with oxygen support and conservative treatment, with a further 5% who require admission to an Intensive Care Unit including intubation and ventilation.The most common complication in severe COVID-19 patients is severe pneumonia, but other complications may include Acute Respiratory Distress Syndrome , Sepsis and Septic Shock, Multiple Organ Failure, including Acute Kidney Injury and Cardiac Injury, which are more prevalent in high-risk groups including Older Age (> 70 years) and those with Co-morbid diseases such as Cardiovascular Disease, Lung Disease, Diabetes and those who are Immunosuppressed.

Patients who were successfully recovered from the acute COVID-19 pneumonia will require health support to define and quantify the consequences of the disease. Alterations of lung tissue such as ground-glass opacities, consolidation, vascular thickening, bronchiectasis, pleural effusion, crazy paving pattern, and irregular solid nodules, may progress in over 80% of patients. Persisting limitations in respiratory function and gas exchange will likely to be more pronounced in the subgroup of ICU survivors. Besides, as in non-COVID-19 related ARDS we can anticipate a high incidence of ICU-acquired weakness that is associated with poor short- as well as long-term outcomes.Patients with COVID-19 seem to be prone to movement-related fatigue, similar to ARDS patients, even in those subjects not developing a critical illness. Therefore, pulmonary rehabilitation is crucial for both admitted and discharged patients of COVID-19.8

As on 1st October 2020, total COVID-19 active cases in Delhi state are: 26,450, and the no of cured cases amount to 2,53,784. The burden of post-COVID-19 treatment illness is more in the form of respiratory complications and subsequently physical weakness, psychological complications in the form of anxiety and depression. The prolonged ICU stay may cause physical de-conditioning along with lung fibrosis and breathing difficulty. PR is crucial and essential for COVID-19 survivors.

Previous studies have already proved the fact that a domiciliary exercise-based telerehabilitation programme under supervision via electronic media is very beneficial for respiratory disorders like Chronic obstructive pulmonary disease.. Patients who were discharged from hospitals following Recovered COVID-19 especially as COVID-19 associated pneumonitis treated in the ICU may require PR after discharge. Considering the traditional PR methods, it will be difficult because of the ongoing current situation and travel restrictions imposed by the government to prevent the spread of COVID-19. The Recovered COVID-19 patients can access PR from remote locations via tele platform hence it prevents further exposure to this pandemic disease, other communicable diseases, psychological support to the elderly patients and it also helps to reduce stress and anxiety.

Multiple guidelines have been published internationally for Covid-19 treatment rehabilitation. At Safdarjung Hospital, the department of Physical medicine & rehabilitation is running a PR clinic in the last two years for COPD patients and other lung disease patients. The same infrastructure can be used for PR of treated COVID-19 pneumonitis patients.

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