| CTRI Number |
CTRI/2025/03/081712 [Registered on: 05/03/2025] Trial Registered Prospectively |
| Last Modified On: |
03/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Translating and validating the sarcopenia quality of life questionnaire into tamil language |
|
Scientific Title of Study
|
Translation and validation of the sarcopenia quality of life questionnaire in tamil language [SarQoL]
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Swathi S |
| Designation |
Student |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Physical Rehabilitation Department, Ground Floor New Block OPD Faculty of physiotherapy Sri Ramachandra Institute of Higher Education and Research(Deemed to be University), No.1 Ramachandra Nagar, Porur, Chennai- 600116
Kancheepuram
TAMIL NADU
Chennai
TAMIL NADU
600116
India |
| Phone |
8072516145 |
| Fax |
|
| Email |
t0223006@sriher.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Chrysolyte M |
| Designation |
Lecturer |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Physical Rehabilitation Department, Ground Floor New Block OPD Faculty of physiotherapy Sri Ramachandra Institute of Higher Education and Research(Deemed to be University), No.1 Ramachandra Nagar, Porur, Chennai- 600116
Kancheepuram
TAMIL NADU
Chennai
TAMIL NADU
600116
India |
| Phone |
9444934432 |
| Fax |
|
| Email |
chrysolyte@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Chrysolyte M |
| Designation |
Lecturer |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Physical Rehabilitation Department, Ground Floor New Block OPD Faculty of physiotherapy Sri Ramachandra Institute of Higher Education and Research(Deemed to be University), No.1 Ramachandra Nagar, Porur, Chennai- 600116
Kancheepuram
TAMIL NADU
Chennai
TAMIL NADU
600116
India |
| Phone |
9444934432 |
| Fax |
|
| Email |
chrysolyte@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Sri Ramachandra Faculty of Physiotherapy
Sri Ramachandra Institute of Higher Education and Research
No.1, Ramachandra Nagar, Sri Ramachandra Nagar, Chennai, Tamil Nadu 600116 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Swathi S |
Sri Ramachandra Faculty of Physiotherapy Sri Ramachandra Institute of Higher education and Research |
Physical Rehabilitation Department,Ground floor,New block OPD , Faculty of Physiotherapy
Sri Ramachandra Institute of Higher education and Research No.1, Ramachandra Nagar, Sri Ramachandra Nagar,Porur, Chennai-600116
Chennai
TAMIL NADU |
8072516145
t0223006@sriher.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Ramachandra Institute of Higher education and Research Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M625||Muscle wasting and atrophy, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Geriatric population with age above 60 years with sarcopenia
A native tamil speaker who can read the questionnaire |
|
| ExclusionCriteria |
| Details |
Patients with cognitive impairments
Patients who are not able to independently ambulate |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Hand dynamometer
Calf girth measurement |
Greater than 28 kg in male and greater than 18 kg in female is normal
Greater than 34 cm in male and greater than 33 cm in female is normal |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Timed up and go test
Body composition analyser
Sarcopenia quality of life questionnaire |
Greater than 10.85 seconds indicates sarcopenia
Less than 7 kg in male and less than 5.4 kg in female indicates sarcopenia |
|
|
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)
|
14/03/2025 |
| 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 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
|
Sarcopenia is a skeletal muscle disorder characterized by loss of muscle function and muscle mass with advancing age. The screening tools used to diagnose sarcopenia are, for muscle mass – calf girth measurement, for muscle strength – hand grip strength, for performance – timed up and go test and body composition analyser. To measure the Quality of life, there are many tools like WHOQOL-BREF, EuroQoL – 5D but specific to sarcopenia – SarQoL Questionnaire is used. The author of original ( French ) version of SarQoL questionnaire is Charlotte Beaudart et all which was published in November 2015 and validated in 2017 . SarQoL has been translated into 37 languages and validated in 18 languages. The Tamil translation has not been done yet. |