| CTRI Number |
CTRI/2026/01/100636 [Registered on: 09/01/2026] Trial Registered Prospectively |
| Last Modified On: |
08/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of age related muscle loss and its impact on daily activities in elderly individuals |
|
Scientific Title of Study
|
Prevalence Of Sarcopenia And Its Association With Muscle Strength And Mass In Elderly Patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sri krisna ananth KS |
| Designation |
Postgraduate |
| Affiliation |
Vinayaka missions kirupananda variyar medical college hospitals |
| Address |
Vinayaka missions kirupananda variyar medical college hospitals sankari main road NH47 Seeragapadi Ariyanoor salem 636308
Salem
TAMIL NADU
636308
India |
| Phone |
9500664497 |
| Fax |
|
| Email |
kssrikrisnaananth98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arulmurugan |
| Designation |
Professor Head of department |
| Affiliation |
Vinayaka missions kirupananda variyar medical college hospitals |
| Address |
Vinayaka missions kirupananda variyar medical college hospitals sankari main road NH47 Seeragapadi Ariyanoor salem 636308
Salem
TAMIL NADU
636308
India |
| Phone |
8248646877 |
| Fax |
|
| Email |
dr.arulc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sri krisna ananth KS |
| Designation |
Postgraduate |
| Affiliation |
Vinayaka missions kirupananda variyar medical college hospitals |
| Address |
Vinayaka missions kirupananda variyar medical college hospitals sankari main road NH47 Seeragapadi Ariyanoor salem 636308
Salem
TAMIL NADU
636308
India |
| Phone |
9500664497 |
| Fax |
|
| Email |
kssrikrisnaananth98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka missions kirupananda variyar medical college hospitals Salem 636308 Tamil Nadu INDIA |
|
|
Primary Sponsor
|
| Name |
Sri krisna ananth KS |
| Address |
Vinayaka missions kirupananda variyar medical college hospitals sankari main road NH47 Seeragapadi Ariyanoor salem 636308 |
| 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 Sri Krisna ananth KS |
Vinayaka missions kirupananda variyar medical college and hospitals salem |
Opd no 16 Department of general Medicine Vinayaka missions kirupananda variyar medical college and hospitals salem
Salem
TAMIL NADU |
9500664497
kssrikrisnaananth98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vinayaka Missions Kirupananda Variyar Medical College and Hospital , Instituitional ethics committee |
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 |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
willing to participate in physical performance test
age greater than 60 years
type 2 Diabetes patient more than 5 years |
|
| ExclusionCriteria |
| Details |
bedridden patients
terminal illness or malignancy
patient on corticosteroids , chemotherapy, pacemaker,metal implants
amputees or those with musculoskeletal deformities |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study is expected to determine the prevalence of sarcopenia and its correlation with muscle strength and mass. It will aid in early identification and timely interventions to prevent frailty and improve quality of life in the elderly. |
This study will assess how common age-related muscle loss is among elderly people and how it is related to muscle strength and muscle size. Measurements will be taken at the start of the study, after 4 weeks, and after 8 weeks. The results may help in early detection of muscle loss and support timely measures to reduce frailty and improve quality of life in older adults. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
18/02/2026 |
| 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
|
Sarcopenia is a geriatric syndrome characterized by progressive loss of skeletal muscle strength and mass contributing to frailty falls disability and reduced quality of life in elderly individuals. Early identification of sarcopenia is essential for timely intervention yet its prevalence and clinical correlates remain insufficiently explored in the Indian elderly population. This cross sectional observational study aims to determine the prevalence of sarcopenia among elderly patients above 60 years attending the outpatient and inpatient departments of General Medicine at VMKVMCH Salem and to evaluate its association with muscle strength and muscle mass. A total of approximately 200 participants will be recruited based on predefined inclusion and exclusion criteria. Muscle strength will be assessed using handgrip dynamometry and muscle mass will be measured using bioelectrical impedance analysis BIA. Sarcopenia will be diagnosed using EWGSOP2 criteria where low muscle strength indicates probable sarcopenia and low muscle mass confirms the diagnosis. Descriptive statistics will estimate prevalence while chi square and correlation analyses will assess associations between sarcopenia muscle strength and muscle mass. The findings are expected to provide epidemiological data on sarcopenia in the regional elderly population and support early screening strategies to prevent functional decline. The study may contribute to improved geriatric assessment protocols and guide future interventional research |