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CTRI Number  CTRI/2021/09/036568 [Registered on: 16/09/2021] Trial Registered Prospectively
Last Modified On: 21/08/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Exercise practices among pregnant women during COVID-19 
Scientific Title of Study   Knowledge, Attitude and Practices about exercises among pregnant women during COVID-19 pandemic  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Preetha R 
Designation  Associate Professor 
Affiliation  Manipal College of Health Professions 
Address  Department of Physiotherapy Manipal College of Health Professions Manipal Academy of Higher Education,Manipal

Udupi
KARNATAKA
576104
India 
Phone  9945670669  
Fax    
Email  preetha.r@manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Preetha R 
Designation  Associate Professor 
Affiliation  Manipal College of Health Professions 
Address  Department of Physiotherapy Manipal College of Health Professions Manipal Academy of Higher Education,Manipal

Udupi
KARNATAKA
576104
India 
Phone  9945670669  
Fax    
Email  preetha.r@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Preetha R 
Designation  Associate Professor 
Affiliation  Manipal College of Health Professions 
Address  Department of Physiotherapy Manipal College of Health Professions Manipal Academy of Higher Education,Manipal

Udupi
KARNATAKA
576104
India 
Phone  9945670669  
Fax    
Email  preetha.r@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Hospital,Manipal 
 
Primary Sponsor  
Name  Preetha R 
Address  Associate Professor Department of Physiotherapy Manipal College of Health Professions,MAHE,Manipal 
Type of Sponsor  Other [self sponsor] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Preetha R  Kasturba Hospital,Manipal  Division of fetal medicine,Classroom-2,Ground floor, Women and Child block, Kasturba Hospital,Manipal
Udupi
KARNATAKA 
9945670669

preetha.r@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Pregnant woman 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Pregnant women aged between 18 to 40 years with a period of gestation > 20 weeks and those who should be able to read and understand English or Kannada language
 
 
ExclusionCriteria 
Details  Those pregnant women who have been advised bed rest or Incompetent cervix or Bad obstetric history or Intra uterine growth restriction
or Placenta previa or Advised not to exercise by treating obstetrician
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Content validated Knowledge, Attitude and Practices questionnaire about exercises among pregnant women during COVID-19 pandemic  Single time during study period 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  Not Applicable 
 
Target Sample Size   Total Sample Size="332"
Sample Size from India="332" 
Final Enrollment numbers achieved (Total)= "189"
Final Enrollment numbers achieved (India)="189" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/10/2021 
Date of Study Completion (India) 21/01/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 21/01/2022 
Estimated Duration of Trial   Years="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
A manuscript will be prepared and will be published in a SCOPUS/WEB OF SCIENCE indexed journal 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

Approval for the study was obtained from the Institutional Research Committee (IRC, MCHP, MAHE, Manipal). Ethical clearance will be obtained from IEC, Kasturba Hospital, Manipal.

Study will be registered under Clinical trial registry of India. Individuals will be screened for inclusion and exclusion criteria. Written informed consent will be obtained from those who will meet the inclusion criteria. A self developed content validated questionnaire will be distributed to the participants and the filled questionnaire will be collected back. The participants will be requested not to use mobile phone to acquire any information. Data will be analysed

 
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