| CTRI Number |
CTRI/2025/01/079742 [Registered on: 29/01/2025] Trial Registered Prospectively |
| Last Modified On: |
28/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Knowing about exercise can help women avoid weak bones after stopping periods. |
|
Scientific Title of Study
|
Awareness of Exercises impact on Osteoporosis in postmenopausal women |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Varanasi kavya |
| Designation |
Student |
| Affiliation |
Gitam School of Physiotherapy |
| Address |
GITAM School of Physiotherapy,
4th Floor, GIMSR Medical college Building, GIMSR Campus, GITAM (Deemed to be University), Gandhinagar, Rushikonda, Visakhapatnam 530045,
Andhra Pradesh.
Nil
Visakhapatnam
ANDHRA PRADESH
530045
India |
| Phone |
7901396453 |
| Fax |
|
| Email |
varanasikavya44@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Varanasi kavya |
| Designation |
Student |
| Affiliation |
Gitam School of Physiotherapy |
| Address |
GITAM School of Physiotherapy,
4th Floor, GIMSR Medical college Building, GIMSR Campus, GITAM (Deemed to be University), Gandhinagar, Rushikonda, Visakhapatnam 530045,
Andhra Pradesh.
Nil
Visakhapatnam
ANDHRA PRADESH
530045
India |
| Phone |
7901396453 |
| Fax |
|
| Email |
varanasikavya44@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ranganath Gangavelli |
| Designation |
Principal |
| Affiliation |
Gitam School ofPhysiotherapy |
| Address |
GITAM School of Physiotherapy,
4th Floor, GIMSR Medical college Building, GIMSR Campus, GITAM (Deemed to be University), Gandhinagar, Rushikonda, Visakhapatnam 530045,
Andhra Pradesh
nil
Visakhapatnam
ANDHRA PRADESH
530045
India |
| Phone |
9844372252 |
| Fax |
|
| Email |
rgangave@gitam.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Varanasi kavya |
| Address |
GITAM School of Physiotherapy,
4th Floor, GIMSR Medical college Building, GIMSR Campus, GITAM (Deemed to be University), Gandhinagar, Rushikonda, Visakhapatnam 530045,
Andhra Pradesh. |
| Type of Sponsor |
Other [self] |
|
|
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 |
| Dr Ranganath Gangavelli |
GIMSR,GITAM University,Visakhapatnam |
GITAM School of Physiotherapy,
4th Floor, GIMSR Medical college Building, GIMSR Campus, GITAM (Deemed to be University), Gandhinagar, Rushikonda, Visakhapatnam 530045,
Andhra Pradesh
Visakhapatnam
ANDHRA PRADESH |
9844372252
rgangave@gitam.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee GIMSR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M810||Age-related osteoporosis without current pathological fracture, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1.Post Hysterectomy
2.Diagnosed with osteoporosis. |
|
| ExclusionCriteria |
| Details |
1.Pre menopausal women
2.Who are included in the similar study within a certain timeframe and the individuals who are unable to comply with study requirements or follow up survey questionnaires |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Osteoporosis Awareness Questionnaire |
single point of time as it is a cross sectional study where the survey questionnarie is administered to the participants and data collected |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
28/02/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The aim of this study is to determine the level of knowledge of osteoporosis among postmenopausal women, using the Osteoporosis Awareness Questionnaire (OAQ).Participants will be briefed on the study’s purpose and procedures and the participant information sheet will be given. Informed consent will be taken from the willing participants. They will be recruited into the study, Osteoporosis awareness questionnaire (OAQ) will be administered and also handed an informative pamphlet about exercises and lifestyle changes. Following that data collection, statistical methods will be employed to analyze the results. |