| CTRI Number |
CTRI/2021/08/036011 [Registered on: 27/08/2021] Trial Registered Prospectively |
| Last Modified On: |
26/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of Quadriceps muscle strength in patients post Covid -19 |
|
Scientific Title of Study
|
Evaluation of Quadriceps muscle strength in patients post Covid -19 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tejuvarshini V |
| Designation |
Student (Masters of Physiotherapy) |
| Affiliation |
Ramaiah Medical College (Department of Physiotherapy) |
| Address |
Ramaiah medical college
(Department of Physiotherapy)
MSR College Rd, M S Ramaiah Nagar, Mathikere, Bengaluru, Karnataka 560054
Ramaiah Medical College Hospital
MSR College Rd, M S Ramaiah Nagar, Mathikere, Bengaluru, Karnataka 560054
Bangalore
KARNATAKA
560054
India |
| Phone |
9035941816 |
| Fax |
|
| Email |
tejuvarshiniv@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Veena Kiran Nambiar |
| Designation |
Associate professor |
| Affiliation |
Ramaiah Medical College (Department of Physiotherapy) |
| Address |
Ramaiah Medical College
MSR College Rd, M S Ramaiah Nagar, Mathikere, Bengaluru, Karnataka 560054
Ramaiah Medical College Hospital
MSR College Rd, M S Ramaiah Nagar, Mathikere, Bengaluru, Karnataka 560054
Bangalore
KARNATAKA
560054
India |
| Phone |
9880575407 |
| Fax |
|
| Email |
veenakiran_nambiar@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Tejuvarshini V |
| Designation |
Student (Masters of Physiotherapy) |
| Affiliation |
Ramaiah Medical College (Department of Physiotherapy) |
| Address |
Ramaiah Medical College
(Department of Physiotherapy)
MSR College Rd, M S Ramaiah Nagar, Mathikere, Bengaluru, Karnataka 560054
Ramaiah Medical College Hospital
MSR College Rd, M S Ramaiah Nagar, Mathikere, Bengaluru, Karnataka 560054
Bangalore
KARNATAKA
560054
India |
| Phone |
9035941816 |
| Fax |
|
| Email |
tejuvarshiniv@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ramaiah Medical College
MSR College Rd, M S Ramaiah Nagar, Mathikere, Bengaluru, Karnataka 560054 |
|
|
Primary Sponsor
|
| Name |
Ramaiah Medical college |
| Address |
MSR College Rd, M S Ramaiah Nagar, Mathikere, Bengaluru, Karnataka 560054 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Tejuvarshini V |
Ramaiah Medical College |
Ramaiah Medical College
(Department of Physiotherapy)
MSR College Rd, M S Ramaiah Nagar, Mathikere, Bengaluru, Karnataka 560054
Bangalore
KARNATAKA |
9035941816
tejuvarshiniv@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Ramaiah Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J22||Unspecified acute lower respiratory infection, (2) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients recovered from COVID -19 illness
1 Age- 20-50yrs
2 Patients whose RT-PCR test results were positive
3 Post COVID-19 illness - Between 6-12weeks
4 Condition of the patient - Self-ambulatory (without assistive devices)
Healthy individuals
1 Age- 20-50yrs |
|
| ExclusionCriteria |
| Details |
Patients recovered from COVID-19 illness
1 Neurologic diseases such as stroke, polyneuropathy, Muscular dystrophy,
Myasthenia gravis, Myositis
2 Orthopaedic conditions such as Total knee replacement, Rheumatoid arthritis,
Hip and Knee osteoarthritis, osteoporosis and recent fractures(3months) of
lower extremity
3 Oncology conditions
4 Cardio-pulmonary conditions such as COPD, congestive heart failure,
peripheral artery disease and cardiac arrest
Renal conditions such as chronic kidney disease, glomerulonephritis, acute
and chronic renal failure
5 Patients who were on steroids as a part of their treatment.
Healthy individuals
1 Abuse of alcohol and drugs
2 Involved in rehabilitation or structured exercise programme during previous
3months
3 Neurologic diseases such as stroke, polyneuropathy, Muscular dystrophy,
Myasthenia gravis, Myositis
4 Orthopaedic conditions such as Total knee replacement, Rheumatoid arthritis,
Hip and Knee osteoarthritis, osteoporosis and recent fractures(3months) of
lower extremity
5 Oncology conditions
6 Cardio-pulmonary conditions such as COPD, congestive heart failure,
peripheral artery disease and cardiac arrest
7 Renal conditions such as chronic kidney disease, glomerulonephritis, acute
and chronic renal failure |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Peak torque (nm) |
6weeks to 12 weeeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Fatigue index |
6 -12 weeks |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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 Enrollment (India)
|
04/09/2021 |
| 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 - YES
- What data in particular will be shared?
Response (Others) -
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 01-11-2022 and end date provided 01-01-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
COVID 19 is an infectious disease caused by novel corona virus. Most people infected with COVID 19 virus will experience symptoms from mild to severe that can permanently detract from their quality of life.
There are various systemic factors such as inflammation, hypoxia, malnutrition and local muscle factors such as deconditioning causing extra pulmonary complications in patients with COVID 19.
If a bad case of COVID 19 or any illness keeps you in bed at home or at hospital for days or weeks, your muscle will also lose strength fast. Lying sick in bed for extended period can lead to muscle atrophy- weakening due to limited use. Healthy people can lose approximately 1% to 1.5% of muscle strength per day with bed rest. Those who are sick may lose even more.
Identifying those patients who have reduced strength between 6 to 12 weeks from the day of testing positive, will allow early intervention targeted at improving quality of life and help them return to their work. Therefore, the aim of the study is to evaluate Quadriceps muscle strength in patients recovered from COVID 19 illness. |