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CTRI Trial Data PDF of Trial CTRI Website URL - http://ctri.nic.in Clinical Trial Details (PDF Generation Date :- Wed, 29 Sep 2021 10:55:03 GMT) CTRI Number CTRI/2021/04/032788 [Registered on: 13/04/2021] - Trial Registered Prospectively Last Modified On 12/04/2021 Post Graduate Thesis Yes Type of Trial Interventional Type of Study Physiotherapy (Not Including YOGA) Study Design Other Public Title of Study Effect of Telerehabilitation based Physiotherapeutic exercises on Physical Function and Quality of life. in patients with COVID 19. Scientific Title of Effect of Telerehabilitation based physiotherapy programme on Quality of life and functional Study capacity in patients with COVID-19: A Feasibility Study Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name Janhavi Khandekar Trial Coordinator (multi-center study) Designation PG Student Affiliation Kasturba Medical College, Mangalore, MAHE. Address Kasturba Medical College, Department of Physiotherapy, Bejai, Mangalore Dakshina Kannada KARNATAKA 575004 India Phone 8108290185 Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Vijay Pratap Singh Query) Designation Associate Professor Affiliation Kasturba Medical College, Mangalore, MAHE. Address Kasturba Medical College, Department of Physiotherapy, Bejai, Mangalore Dakshina Kannada KARNATAKA 575004 India Phone 8967035789 Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Dr Vijay Pratap Singh Designation Associate Professor Affiliation Kasturba Medical College, Mangalore, MAHE. Address Kasturba Medical College, Department of Physiotherapy, Bejai, Mangalore Dakshina Kannada KARNATAKA 575004 India page 1 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in Phone 8967035789 Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Kasturba Medical College, Trunk Road, Bejai, Mangalore-575004. Primary Sponsor Primary Sponsor Details Name nil Address nil Type of Sponsor Other [nil] 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 Janhavi Khandekar KMC Attavar KMC Hospital, 8108290185 Nandigudda Road, Attavar, Mangalore- [email protected] 575001 Dakshina Kannada KARNATAKA Janhavi Khandekar KMC Jyothi KMC Hospital, opposite 8108290185 jyothi theatre, Ambedkar Circle, [email protected] Mangalore- 575001 Dakshina Kannada KARNATAKA Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Institutional Ethics Approved 18/02/2021 No Committee, KMC, Mangalore. 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 Telerehabilitation Breathing exercises, Strength training, Aerobic exercises. Comparator Agent nil nil Inclusion Criteria Inclusion Criteria Age From 18.00 Year(s) Age To 75.00 Year(s) Gender Both Details In-patient as well as post-discharge COVID-19 patients with a definitive PCR reported diagnosis of COVID-19.<br/> Age 18-75 years.<br/> Patients with MOCA score more than 26.<br/> Independent ambulation.<br/> Patients with minimum one smartphone in house with good internet connectivity.<br/> page 2 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in Exclusion Criteria Exclusion Criteria Details Any other respiratory condition. Any Cardiac condition (moderate to severe). Other neuromuscular condition affecting respiratory or physical function. Visual impairments causing difficulty in operating the smartphone. Method of Generating Random Sequence Method of Concealment Blinding/Masking Primary Outcome Outcome Timepoints 6 Minute Walk Test, SF-36 Scores. 6 Minute Walk Test, SF-36 Scores. Secondary Outcome Outcome Timepoints nil nil Target Sample Size Total Sample Size=20 Sample Size from India=20 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 27/04/2021 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=1 Trial Months=0 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Not Yet Recruiting Trial (India) Publication Details nil Brief Summary In a nutshell, the rehabilitation of a patient infected by COVID-19 can be started while in in-patient phase and continued even after they are discharged and out of the hospital. Telerehabilitation is being encouraged to ensure safety of patient as well as of the therapist. Protocols for the same are being experimented all over the world, but are not available in published format. objectives of this study are to assess and compare pre-test and post-test 6 minute walk test and SF-36 scores. Protocol given would include- Duration of protocol- 6 weeks. page 3 / 4 PDF of Trial CTRI Website URL - http://ctri.nic.in Elements- respiratory rehabilitation. Frequency- 2-3 times/ day for 6 weeks. Intensity- light (less than 3 on modified Borg scale) Time- 5-10 min. Type- bronchial hygiene (ACBT), pursed lip breathing, diaphragmatic strengthening, thoracic expansion exercises. Aerobic exercises. Frequency- 3-5 sessions per week for 6 weeks. Intensity- light ( less than 5 on modified borg scale) Time- 20-30 min. Type- walking, slow jogging. Strength training. Frequency- 3-5 sessions per week for 6 weeks. Intensity- light less than 3 on modified borg scale. Time- time required for completing 2-3 sets of 8-12 reps. Type- free weights, body weight exercises like sit to stand for lower limb. page 4 / 4 Powered by TCPDF (www.tcpdf.org).
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