| CTRI Number |
CTRI/2024/12/078413 [Registered on: 20/12/2024] Trial Registered Prospectively |
| Last Modified On: |
19/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
How Physical Activity Affects Autonomic Nervous System Health in Menopausal Women |
|
Scientific Title of Study
|
Correlation of Autonomic Function Tests With Physical Activity in Menopausal 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 |
Dr Pranjali Preksha |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Obstetrics and Gynecology, Kasturba Medical College, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9934149359 |
| Fax |
|
| Email |
pranjali.tanya9jul@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shyamala Guruvare |
| Designation |
Head of Unit |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Obstetrics and Gynecology, Kasturba Medical College, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9844551037 |
| Fax |
|
| Email |
shyamala.g@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shyamala Guruvare |
| Designation |
Head of Unit |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Obstetrics and Gynecology, Kasturba Medical College, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9844551037 |
| Fax |
|
| Email |
shyamala.g@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, MAHE, Tiger Circle, Madhav Nagar, Manipal, Karnataka-576104 |
|
|
Primary Sponsor
|
| Name |
Dr Pranjali Preksha |
| Address |
Department of Obstetrics and Gynecology, Kasturba Medical College, MAHE, Tiger Circle, Madhav Nagar, Manipal, Karnataka-576104 |
| 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 Pranjali Preksha |
Kasturba Medical College |
Department of Obstetrics and Gynecology, Kasturba Medical College, MAHE, Tiger Circle, Madhav Nagar, Manipal, Karnataka-576104
Udupi
KARNATAKA |
9934149359
pranjali.tanya9jul@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Menopausal women (women above 45 years with one year amenorrhea) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1)Healthy Menopausal women (women above 45 years with one year amenorrhea) |
|
| ExclusionCriteria |
| Details |
1) Diabetes Mellitus
2) Hypertension
3)Thyroid disorder
4) Cardiac disease on treatment
5)Autonomic neuropathy
6) Parkinson’s Disease or any other significant neurological conditions
7) Smoking
8)Alcoholism
9) Females with physical disabilities limiting mobility
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Establishing the relationship between physical activity levels and Autonomic function test results |
1 year and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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)
|
06/01/2025 |
| 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="1"
Months="6"
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
|
The proposed study is a prospective cross sectional study for establishing the Correlation of Autonomic Function Tests With Physical Activity in Menopausal Women. Post Menopausal Women among the Kasturba Medical College and Hospital workforce of all grades and women attending OBG department outpatients fitting into the inclusion criteria will be selected. Women volunteers from within the university workforce will be invited to take part in the study. While doing so, we will try to ensure participation of women from various classes of workforce including those at Kasturba Hospital and Medical College. The volunteers will be explained in detail the procedure and outcome of the study. Volunteers willing to participate will be selected. Appropriate consent and demographic and clinical details will be taken. Physical activity assessment will be done using the Global Physical Activity Questionnaire – physical activity score will be calculated. Autonomic Function tests will be performed at the Department of Physiology, Kasturba Medical College, Manipal. Statistical analysis of Physical activity score versus autonomic function test levels will be done. |