| CTRI Number |
CTRI/2024/07/071624 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
26/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Physical Activity level and Severity of Menopausal Symptoms in postmenopausal women: A cross sectional study |
|
Scientific Title of Study
|
Correlation of physical activity level with severity of menopausal symptoms in postmenopausal women: A cross sectional study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrAnkita shah |
| Designation |
Assistant professor |
| Affiliation |
Gujarat University |
| Address |
V-501 sardar patel nagar
shashtri nagar cross road
naranpura
ahmedabad
Gujarat University
Navrangpura, Ahmedabad
380009
Ahmadabad
GUJARAT
380013
India |
| Phone |
8238505498 |
| Fax |
|
| Email |
ankitashah4cardio@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrAnkita shah |
| Designation |
Assistant professor |
| Affiliation |
kpgu |
| Address |
V-501 sardar patel nagar
shashtri nagar cross road
naranpura
ahmedabad
Ahmadabad
GUJARAT
380013
India |
| Phone |
8238505498 |
| Fax |
|
| Email |
ankitashah4cardio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrAnkita shah |
| Designation |
Assistant professor |
| Affiliation |
kiran & pallavi patel global university |
| Address |
V-501 sardar patel nagar
shashtri nagar cross road
naranpura
ahmedabad
Vadodara
GUJARAT
380013
India |
| Phone |
8238505498 |
| Fax |
|
| Email |
ankitashah4cardio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gujarat university
Naranpura, ahmedabad 38009 , Gujarat , INDIA |
|
|
Primary Sponsor
|
| Name |
GUJARAT UNIVERSITY |
| Address |
GUJARAT UNIVERSITY
NARANPURA
AHMEDABAD
GUJARAT
INDIA |
| Type of Sponsor |
Government medical college |
|
|
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 Ankita shah |
vadodara |
Kiran & pallavi patel glbal university
Vadodara
GUJARAT |
8238505498
ankitashah4cardio@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AHMEDABAD INSTITUTE OF MEDCAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
menopausal women
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
IPAQ & MRS |
Physical activity & menopausal symptoms |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
POST MENOPAUSAL WOMEN.
WILLING TO PARTICIPATE |
|
| ExclusionCriteria |
| Details |
any type of cardiovascular, respiratory, orthopedic, neurological, psychiatric disorder.
uncontrolled metabolic disorders
WOMEN TAKING HRT |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
IPAQ
MRS |
one time- as its a cross sectional study. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| compare IPAQ between urban and rural women |
IPAQ |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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)
|
09/08/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
A sample of women will be selected according to the inclusion and exclusion criteria. Written, informed consent will be obtained from the selected females after providing them adequate information about the nature and purpose of the study. Physical activity level will be assessed using IPAQ Guajarati/English version of questionnaire. For comparing other variables, a proforma will be made for getting all the information needed from the subjects. To evaluate the post menopausal symptoms they will be asked to fill the translated and adapted version of MRS Scale. Prevalence, incidence and severity of various symptoms in the population will be determined. Psychometric properties of the questionnaire including Test-retest reliability and face validity will be calculated. Statistical analysis will be done using SPSS version 20.0 using appropriate statistical tests |