CTRI

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CTRI Number

CTRI/2025/04/083920 [Registered on: 02/04/2025] Trial Registered Prospectively

Last Modified On:

18/03/2025

Post Graduate Thesis

Type of Trial

Observational

Type of Study

Cross Sectional Study

Study Design

Other

Public Title of Study

A Simple Screening Tool to Detect muscle loss in older adults visiting the outpatient department

Scientific Title of Study

A Proposed Clinical Screening Tool for Sarcopenia among Elderly Population Visiting the Out Patient Department of Tertiary Care Hospital

Trial Acronym

nil

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	E Dermica Ezhil
Designation	Undergraduate
Affiliation	Sri Ramachandra Institute of Higher Education and Research(deemed to be university)
Address	Faculty of Physiotherapy, Room no 1.1, Floor 1, Sri Ramachandra Institute of Higher Education and Research(Deemed to be university) Porur, Chennai-600116,Tamilnadu,India. Chennai TAMIL NADU 600116 India
Phone	6379394895
Fax
Email	dermiezhil08@gmail.com

Details of Contact Person
Scientific Query

Name	M Chrysolyte
Designation	Lecturer
Affiliation	Sri Ramachandra Institute of Higher Education and Research(deemed to be university)
Address	Faculty of Physiotherapy, Room no 1.1, Floor 1, Sri Ramachandra Institute of Higher Education and Research(Deemed to be university) Porur, Chennai-600116,Tamilnadu,India. Chennai TAMIL NADU 600116 India
Phone	9444934432
Fax
Email	chrysolyte@sriramachandra.edu.in

Details of Contact Person
Public Query

Name	J Agnes Kaaviya
Designation	Undergraduate
Affiliation	Sri Ramachandra Institute of Higher Education and Research(deemed to be university)
Address	Faculty of Physiotherapy, Room no 1.1, Floor 1, Sri Ramachandra Institute of Higher Education and Research(Deemed to be university) Porur, Chennai-600116,Tamilnadu,India. Chennai TAMIL NADU 600116 India
Phone	9445670137
Fax
Email	agneskaaviya@gmail.com

Source of Monetary or Material Support

Sri Ramachandra Institute of Higher Education and Research Institute

Primary Sponsor

Name	Sri Ramachandra Institute of Higher Education and Research Institute
Address	Sri Ramachandra Institute of Higher Education and Research Institute(Deemed to be University)Porur,Chennai. 600116
Type of Sponsor	Private medical college

Details of Secondary Sponsor

Name	Address
Nil	Nil

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
E Dermica Ezhil	Sri Ramachandra Hospital	Faculty of physiotherapy, Physiotherapy outpatient department, ground floor G-0, Sri Ramachandra Institute of Higher Education and Research(Deemed to be university) Porur, Chennai-600116,Tamilnadu,India. Chennai TAMIL NADU	6379394895 dermiezhil08@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Ethics Committee for Students Project, Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research(Deemed to be university) Porur, Chennai-600116,Tamilnadu,India.	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	patient visiting outpatient department

Intervention / Comparator Agent

Type	Name	Details
Intervention	Nil	Nil

Inclusion Criteria

Age From	60.00 Year(s)
Age To	95.00 Year(s)
Gender	Both
Details	1.Adult above 60 years of both gender with symptomatic loss of muscle mass, strength and function. 2.Patients who have sufficient cognition and communication skills to understand the nature of study.

ExclusionCriteria

Details

1.Acute and chronic cardiac and pulmonary problem.
2.Recent musculoskeletal upper and lower extremities injury.
3.Upper and lower limb oedema
4.Cognitively impaired

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Sarc-F questionnaire Sarc Calf and Arm circumference	At baseline

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)

01/05/2025

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="1"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

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

•TITLE OF THE PROPOSAL

A proposed clinical screening tool for sarcopenia among elderly population visiting the outpatient department of tertiary care hospital

•AIM OF THE STUDY:

To identify sarcopenia among community dwelling older adults using a simple screening tool.

•OBJECTIVES OF THE STUDY:

To evaluate the diagnostic ability of the SARC-Calf+AC tool in identifying sarcopenia in people visiting outpatient department.

•PROCEDURE:

Subject with gradual loss of muscle mass, strength and function are recruited for study. Demographic survey (name, age, gender, height, weight, BMI, comorbidities and diagnosis) are collected. To screen the patients for sarcopenia SARC-F questionnaire is used. If the score is >4, it indicates the presence of sarcopenia. Along with SARC-F questionnaire patient’s arm and calf girth is measured to produce more specific diagnosis. Questionnaire include difficulties in daily activities and girth measurement through inch tape.