| CTRI Number |
CTRI/2025/12/099796 [Registered on: 24/12/2025] Trial Registered Prospectively |
| Last Modified On: |
24/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Age related muscle loss and its relationship with tiredness and quality of life among the elderly |
|
Scientific Title of Study
|
Influence of demographic, clinical variables and fatigue severity on quality of life, elderly population with sarcopenia |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Chrysolyte Mohanan |
| Designation |
Lecturer |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Plot no 2 pownammal Street, thiruvalluvar Nagar mugalivakkam
Chennai
Sri Ramachandra Faculty of Physiotherapy, 2nd floor, Room 2.4, Mount poonammallee road, Porur, Chennai
Chennai
TAMIL NADU
600125
India |
| Phone |
09444934432 |
| Fax |
|
| Email |
chrysolyte@sriramachandra.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
SUBBIAH KANTHANATHAN |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Sri Ramachandra Faculty of Physiotherapy, 2nd floor, Room 1, Mouint Poonamallee Road, Ramachandra nagar, SRIHER, Porur, Chennai
Sri Ramachandra Faculty of Physiotherapy, 2nd floor, Room 1, Mouint Poonamallee Road, Ramachandra nagar, SRIHER, Porur, Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
09443033118 |
| Fax |
|
| Email |
subbiah@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
SUBBIAH KANTHANATHAN |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Sri Ramachandra Faculty of Physiotherapy, 2nd floor, Room 2.1, Mount Poonamallee Road, Ramachandra nagar, SRIHER, Porur, Chennai
Sri Ramachandra Faculty of Physiotherapy, 2nd floor, Room 2.1, Mouint Poonamallee Road, Ramachandra nagar, SRIHER, Porur, Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
09443033118 |
| Fax |
|
| Email |
subbiah@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai 600116. |
|
|
Primary Sponsor
|
| Name |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
No.1, Mount Poonamallee Road, Porur, Chennai 600116 |
| 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 |
| SUBBIAH KANTHANATHAN |
Sri Ramachandra Hospital |
1, Ramachandra nagar, SRIHER, Porur,
Chennai
TAMIL NADU |
09443033118
subbiah@sriramachandra.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Ramachandra Institutional Ethics Committee, 3rd floor, Medical College building, |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M638||Disorders of muscle in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Able to walk
Cognitively intact
Diagnosed to have sarcopenia
Willing to give consent
|
|
| ExclusionCriteria |
| Details |
Not able to walk
Previous lowerlimb surgeries
Multiple comorbidities |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quality of life |
Baseline only |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Fatigue severity score |
baseline one measurement only |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/01/2026 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 01-01-2026 and end date provided 01-12-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Elderly participants visiting the tertiary care hospital will be screened for sarcopenia based on clinical criteria. After obtaining informed consent, demographic details such as age, gender, education, and clinical history will be collected. Participants will then undergo a series of physical assessments including handgrip strength (HGS), calf girth (CG), and timed up-and-go (TUG) tests. Additional assessments will include the Chair Stand Test (CST) to evaluate lower body strength, the Fatigue Severity Scale (FSS) to measure fatigue levels, and a standardized Quality of Life (QoL) questionnaire. Based on their FSS scores, participants will be categorized into mild and severe fatigue groups, and corresponding QoL outcomes will be analyzed to determine the influence of fatigue severity and clinical-demographic factors on quality of life in elderly individuals with sarcopenia |