| CTRI Number |
CTRI/2025/04/084083 [Registered on: 03/04/2025] Trial Registered Prospectively |
| Last Modified On: |
02/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study To Find Out The Magnitude Of Sarcopenia Among Elderly Persons Attending A Tertiary Health Care Centre Of North India |
|
Scientific Title of Study
|
A cross sectional observational study to estimate the magnitude of sarcopenia among elderly subjects attending a tertiary health care center of North India |
| 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 Ayush Singh |
| Designation |
Junior Resident I |
| Affiliation |
GSVM MEDICAL COLLEGE, KANPUR |
| Address |
Room No 24
Department of Medicine
GSVM Medical College
Kanpur Nagar India
Pin Code-208002
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
8770913817 |
| Fax |
|
| Email |
drayushsingh3011@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saurabh Agarwal |
| Designation |
Professor |
| Affiliation |
GSVM MEDICAL COLLEGE, KANPUR |
| Address |
Room No 24
Department Of Medicine
GSVM Medical College
Kanpur Nagar
Uttar Pradesh
India
Pin Code-208002
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
9415039582 |
| Fax |
|
| Email |
dragarwalsaurabh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ayush Singh |
| Designation |
Junior Resident I |
| Affiliation |
GSVM MEDICAL COLLEGE, KANPUR |
| Address |
Room No 24
Department Of Medicine, GSVM Medical College
Kanpur Nagar
Uttar Pradesh
India
Pin Code-208002
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
8770913817 |
| Fax |
|
| Email |
drayushsingh3011@gmail.com |
|
|
Source of Monetary or Material Support
|
| GSVM Medical College, Kanpur Nagar India
Pin Code-208002 |
|
|
Primary Sponsor
|
| Name |
GSVM Medical College Kanpur Nagar |
| Address |
GSVM Medical College
Kanpur Nagar
India
Pin Code-208002 |
| 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 Ayush Singh |
GSVM Medical College |
Room No 24
Department Of Medicine
Gsvm Medical College
Swaroop Nagar
Kanpur Nagar
PIN code-208002
Kanpur Nagar
UTTAR PRADESH |
9919831959
drayushsingh3011@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE GSVM MEDICAL COLLEGE KANPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M628||Other specified disorders of muscle, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Age more than 60 years both Male and Female
Normal healthy subjects and subjects suffering from any chronic stable co-morbid condition, chronic obstructive pulmonary disease, diabetes mellitus HbA1c less than10%, chronic kidney disease, Chronic Liver Disease etc)
Functional decline or limitation
Unintentional weight loss
Depressive mood
Cognitive impairment
Repeated falls
Malnutrition
and having either SARCF score equal to or greater than 4 or SARCCalF equal to or greater than11 |
|
| ExclusionCriteria |
| Details |
Bed-ridden subjects due to anticipated problems in workup
Pregnant and lactating females
Acutely ill subjects
Patients admitted to ICU
Subjects with contraindication for MRI
Malignancy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate the magnitude of sarcopenia among elderly subjects attending a tertiary care center of North India based on Asian Working Group for Sarcopenia (AWGS) 2019 criteria for the diagnosis of Sarcopenia. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Quality of Life (SARQOL) |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="233"
Sample Size from India="233"
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)
|
15/04/2025 |
| 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="2"
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
|
Sarcopenia is an underdiagnosed disease entity adding to morbidity and mortality among elderly population. It is characterized by loss of muscle strength & muscle mass. It adversely affects the quality of life of the subject also. The entity is under recognized in day to day practice. There are ways to address this problem and hence improve the outcome also. The current study will use the diagnostic criteria given by the Asian Working Group for Sarcopenia 2019 for the diagnosis of sarcopenia. |