| CTRI Number |
CTRI/2020/05/025257 [Registered on: 20/05/2020] Trial Registered Prospectively |
| Last Modified On: |
05/05/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To find out relation between hip thigh calf arm forarm waist circumference and weakness in postmenopausal women |
|
Scientific Title of Study
|
ASSOCIATION BETWEEN ANTHROPOMETRIC MEASURES AND FRAILTY AMONG POSTMENOPAUSAL WOMEN-A CROSS SECTIONAL STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RUDALI NITIN HUSALE |
| Designation |
1st MPT community medical sciences |
| Affiliation |
DVVPFS COLLEGE OF PHYSIOTHERAPY |
| Address |
mahatma gandhi vidyalaya pravaranagar, tel rahata ,dist ahmednagar
dvvpfs college of physiotherapy opp,govt milk dairy ,midc Ahmednagar-414111 DVVPFS college of physiotherapy opp,Govt Milk dairy ,MIDC ,Ahmednagar -414111 Ahmednagar
Ahmadnagar
MAHARASHTRA
413712
India |
| Phone |
9370262985 |
| Fax |
|
| Email |
husalerudalee13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shyam Devidas Ganvir |
| Designation |
Principal Cum Professor |
| Affiliation |
Dr. Vithalrao Vikhe Patil Foundations College of Physiotherapy |
| Address |
Dr. Vithalrao Vikhe Patil Foundations College of Physiotherapy, Opp
Govt Milk Dairy, Vadgaon Gupta, Ahmednagar- 414111
MAHARASHTRA
India
Dr. Vithalrao Vikhe Patil Foundations College of Physiotherapy, Opp
Govt Milk Dairy, Vadgaon Gupta, Ahmednagar- 414111
MAHARASHTRA
India
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
8554990224 |
| Fax |
2779757 |
| Email |
shyam.ganvir@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
RUDALI NITIN HUSALE |
| Designation |
MPT 1ST |
| Affiliation |
DVVPFS COLLEGE OF PHYSIOTHERAPY |
| Address |
mahatma gandhi vidyalaya pravaranagar, tel rahata ,dist ahmednagar staff quarters room no 19
dvvpfs college of physiotherapy opp ,Govt milk dairy ,midc Ahmednagar -41411 DVVPFS college of physiotherapy opp,Govt AHMEDNAGAR .
Ahmadnagar
MAHARASHTRA
413712
India |
| Phone |
9370262985 |
| Fax |
|
| Email |
husalerudalee13@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DVVPFS college of physiotherapy |
| Address |
Dr. Vithalrao Vikhe Patil Foundations College of Physiotherapy, Opp Govt. Milk Dairy, MIDC,
Ahmednagar-414111 |
| Type of Sponsor |
Private 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 |
| Rudali Nitin Husale |
dr vitthalrao vikhe patil college of physiotherapy Ahmednagar |
Dr. Vithalrao Vikhe Patil College of Physiotherapy, Oppo. Govt.Milk Diary, MIDC, Ahmednagar 414111 Ahmadnagar MAHARASHTRA
Ahmadnagar
MAHARASHTRA |
9370262985
husalerudalee13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Post Menopausal Women. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1.Age 45-65 years
2.Naturally induced postmenopausal women.
3.All the womens working and housewife
4.Be at least 1 year post –cessation of menses for early postmenopausal women and at least 5 years post –cessation of menses for late postmenopausal women
|
|
| ExclusionCriteria |
| Details |
1.Premature menopause
2.Mild cognitive impairments
3.Recent fractures of upper limb and lower limb
4.Recent heart surgeries
5.Angina pectoris or myocardial infarction
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| height,weight, FI, Waist Hip Ratio,Hip circumference, Calf and Thigh circumference, Arm and Forearm circumference |
1 year |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
11/08/2020 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a Cross Sectional Study, with Study setting at Ahmednagar District. aim of this study to determine the correlation between anthropometric measures and friality among postmenopausal women. Objective: To find out WHR in postmenopausal women. To find out calf circumference in postmenopausal womens. To find out arm circumference in postmenopausal women. To find out forearm circumference in postmenopausal women.To find out thigh circumference in postmenopausal women.To find out waist circumference in postmenopausal women.To find out hip circumference in postmenopausal women. The outcome measures included height,weight, Waist Hip Ratio, FI, Hip circumference, Calf and Thigh circumference, Arm and Forearm circumference.The study duration is of 1 year. |