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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  
Nil 
 
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  
Status 
Not Applicable 
 
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.

It is a cross-sectional, observational study on 75 stable patients tested positive for COVID-19 who are willing to participate in the study. After obtaining a written consent, the participants will be administered Fatigue Assessment Scale and One Minute Sit to Stand test will be performed. The patient’s CPK and CRP levels will be recorded. Time required is about 8-10 minutes.

 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.                                                                                                                         

 
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