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
|
|
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
|
|
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 |