| CTRI Number |
CTRI/2018/04/013382 [Registered on: 19/04/2018] Trial Registered Prospectively |
| Last Modified On: |
05/04/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
estimating the bone strength in older adults using clinical tools |
|
Scientific Title of Study
|
Development of regression model for predicting osteoporosis among older adults |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sneha Mary Jacob |
| Designation |
Post- graduate student |
| Affiliation |
School of Allied Health Sciences |
| Address |
Department of Physiotherapy
School of Allied Health Sciences
Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
7019986451 |
| Fax |
|
| Email |
sneha.jacob27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Girish N |
| Designation |
Associate Professor |
| Affiliation |
School of Allied Health Sciences |
| Address |
Department of Physiotherapy
School of Allied Health Sciences
Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9886782114 |
| Fax |
|
| Email |
girish.n@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Sidhiprada Mohapatra |
| Designation |
Assistant Professor |
| Affiliation |
School of Allied Health Sciences |
| Address |
Department of Physiotherapy
School of Allied Health Sciences
Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8050730675 |
| Fax |
|
| Email |
sidhi.mohapatra@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, School of Allied Health Sciences, Manipal Academy of Higher Education, Madhav Nagar, Manipal-576104 |
|
|
Primary Sponsor
|
| Name |
Investigator initiated trial |
| Address |
Department of Physiotherapy, School of Allied Health Sciences, Manipal Academy of Higher Education, Manipal |
| Type of Sponsor |
Other [Educational Institution] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Sneha Mary Jacob |
Department of Obstestrics and Gynaecology |
Department of Obstestrics and Gynaecology,Kasturba Hospital, Manipal, 576104
Udupi
KARNATAKA |
7019986451
sneha.jacob27@gmail.com |
| Sneha Mary Jacob |
Department of Physiotherapy |
Department of Physiotherapy, Kasturba Hospital, Manipal, 576104
Udupi
KARNATAKA |
7019986451
sneha.jacob27@gmail.com |
| Sneha Mary Jacob |
Depatment of Orthopaedics |
Department of Orthopaedics
Kasturba Hospital
Manipal - 576104
Udupi
KARNATAKA |
7019986451
sneha.jacob27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Osteoporotic and healthy individuals |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
55.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Age group 55 - 80
Either gender
Mini mental state examination score ≥24
Ambulant without assistance
|
|
| ExclusionCriteria |
| Details |
Known neuromuscular, cardiovascular, and musculoskeletal conditions contraindicated for physical performance measures.
End stage disease
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Short physical performance battery protocol |
Once |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Short nutritional assessment questionaire |
Once |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
15/04/2018 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a case control study to develop a regression model for predicting the risk of osteoporosis among older adults. A
predictive model may help address the limitations of diagnostic tools in terms
of usability, accessibility and cost. A model incorporating risk factors and
physical performance measures for predicting osteoporosis among older adults is
lacking. Permission has been sought from Institutional Research Commitee, SOAHS and Institutional Ethics Commitee, Kasturba Medical College and Kasturba Hospital, Manipal. Permission has been sought from the respective authors for the questionnaires. Informed consent and Participant Information sheet will be administered to the subjects priorly, values will be recorded after which data will be analyzed and will be reported. |