| CTRI Number |
CTRI/2020/09/027993 [Registered on: 23/09/2020] Trial Registered Prospectively |
| Last Modified On: |
08/03/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of effect of COVID-19 on fatigue and exercise capacity in patients with Covid-19 treated at a government tertiary care hospital. |
|
Scientific Title of Study
|
Impact of COVID-19 on fatigue and exercise capacity in patients treated at a municipal
tertiary care hospital dedicated to COVID-19 management |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chhaya Verma |
| Designation |
Professor and Head |
| Affiliation |
Physiotherapy School and Centre, TNMC and BYLNCH, Mumbai |
| Address |
Physiotherapy School and Centre, OPD no. 24, N Building, TNMC and BYLNCH, Dr. A. L. Nair Marg, Mumbai Central, Mumbai
Mumbai MAHARASHTRA 400008 India |
| Phone |
9082797203 |
| Fax |
022-23072663 |
| Email |
chhayaverma2263@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Sayali Mhatre |
| Designation |
Postgraduate Physiotherapy Student |
| Affiliation |
Physiotherapy School and Centre, TNMC and BYLNCH, Mumbai |
| Address |
Physiotherapy School and Centre, OPD no. 24, N Building, TNMC and BYLNCH, Dr. A. L. Nair Marg, Mumbai Central, Mumbai
Mumbai MAHARASHTRA 400008 India |
| Phone |
8983488293 |
| Fax |
|
| Email |
sayali.1009@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Anagha Mangaonkar |
| Designation |
Postgraduate Physiotherapy Student |
| Affiliation |
Physiotherapy School and Centre, TNMC and BYLNCH, Mumbai |
| Address |
Physiotherapy School and Centre, OPD no. 24, N Building, TNMC and BYLNCH, Dr. A. L. Nair Marg, Mumbai Central, Mumbai
Mumbai MAHARASHTRA 400008 India |
| Phone |
9820053684 |
| Fax |
|
| Email |
anaghamangaonkar29@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Chhaya Verma |
| Address |
Physiotherapy School and Centre, TNMC BYL Nair Ch Hospital, Mumbai Central, Mumbai- 400008 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Chhaya Verma |
BYL Nair Charitable Hospital |
COVID wards, H Building, BYL Nair Charitable Hospital, Dr. A.L.Nair Marg, Mumbai Central, Mumbai Mumbai MAHARASHTRA |
9082797203 022-23072663 chhayaverma2263@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Academic Research Projects |
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 |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1)Adult Patients tested positive for COVID 19 on Reverse Transcriptase Polymerase Chain reaction (RT PCR)
2)Stable Patients fulfilling the discharge criteria practiced by the hospital |
|
| ExclusionCriteria |
| Details |
1)Patients not willing to give consent
2)Patients on immuno-compromising drugs
3)Patients with cognitive impairment
4)Patients with pre existing neuromuscular disorders |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fatigue Assessment Scale |
At baseline only |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| One Minute Sit to Stand Test |
At baseline only |
| Creatinine Phosphokinase level |
At baseline only |
| C-Reactive Protein level |
At baseline only |
|
|
Target Sample Size
|
Total Sample Size="75" Sample Size from India="75"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="75" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/09/2020 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="3" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
COVID 19 is a highly contagious disease caused by a novel virus SARS COV2 which was identified in the Wuhan city of China in December 2019. As Covid 19 primarily affects the lungs, it causes reduced oxygen supply to the periphery leading to peripheral fatigue. Prevalence of musculoskeletal symptoms like fatigue, myalgia and arthralgia has been proved in patients with COVID 19. Exercise capacity is defined as the maximum amount of physical exertion that a patient can sustain. A decline in the TLC [Total Lung Capacity] and subsequent reduction in exercise capacity in Covid-19 has been observed in early convalescence phase. Studies have shown that increasing the exercise capacity improves the function of immune and respiratory systems in patients with Covid-19. The aim of our study is to assess the impact of Covid-19 on fatigue and exercise capacity in patients treated at a municipal tertiary care hospital dedicated to COVID-19 management. Data will be collected and tested for normal distribution using Kolmogorov Smirnov Test. If the data passes normality test, Pearson’s correlation coefficient will be used to test the correlation between outcome measures. If the data does not pass normality test, Spearman Rank’s correlation will be used to test the correlation between outcome measures. |