| CTRI Number |
CTRI/2025/11/097320 [Registered on: 13/11/2025] Trial Registered Prospectively |
| Last Modified On: |
12/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross-sectional Comparative study |
| Study Design |
Other |
|
Public Title of Study
|
A study to compare skin fold measurement and bioelectrical impedance for assessing muscle and body fat in older adults |
|
Scientific Title of Study
|
Evaluating the Concurrent Validity of Bioelectrical Impedance Analysis and Skinfold Measurements for Assessing Muscle Mass and Fat Distribution in Older Adults at Risk of 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 |
Sanjana Naik |
| Designation |
Student |
| Affiliation |
Parul Institute of Physiotherapy |
| Address |
Room no 18.2 Orthopedic OPD ground floor Parul Sevashram Hospital Parul University PO Limda Tal. Waghodia Dist. Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
8296373192 |
| Fax |
|
| Email |
sanjananaik9999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dwija Yagnik |
| Designation |
Assistant Professor |
| Affiliation |
Parul Institute of Physiotherapy |
| Address |
Room no 18.2 Orthopedic OPD ground floor Parul Sevashram Hospital Parul University PO Limda Tal. Waghodia Dist. Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9909021553 |
| Fax |
|
| Email |
dwija.yagnik74008@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Sanjana Naik |
| Designation |
Student |
| Affiliation |
Parul Institute of Physiotherapy |
| Address |
Room no 18.2 Orthopedic OPD ground floor Parul Sevashram Hospital Parul University PO Limda Tal. Waghodia Dist. Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
8296373192 |
| Fax |
|
| Email |
sanjananaik9999@gmail.com |
|
|
Source of Monetary or Material Support
|
| Material support (BIA device and Skin-fold caliper) provided by Parul Institute of Physiotherapy department |
| No monetary support. Self-funded. |
|
|
Primary Sponsor
|
| Name |
Sanjana Naik |
| Address |
Parul Institute of Physiotherapy P.O Limda Tal. Waghodia Dist. Vadodara Gujarat India 391760 |
| Type of Sponsor |
Other [Physiotherapy] |
|
|
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 Sanjana Naik |
Parul Sevashram Hospital |
Room no 18.2 Orthopedic OPD ground floor Parul Sevashram Hospital Parul University PO Limda Tal. Waghodia Dist. Vadodara
Vadodara
GUJARAT |
8296373192
sanjananaik9999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PARUL UNIVERSITY INSTITUTIONAL ETHICS COMMITTEE FOR HUMAN RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
AT RISK OF SARCOPENIA |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bio-electrical impedance analysis |
Body composition (muscle mass and fat mass) will be assessed using a standard bioelectrical impedance analyser.
5-10minutes per patient |
| Comparator Agent |
Skinfold Thickness Measurement |
Body fat percentage will also be calculated using skinfold calliper measurements taken at standard anatomical sites.
10-15 minutes per patient. |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Identified as at risk of sarcopenia based on screening tools
Reduced physical performance(slow gait speed or low handgrip strength)
Able to provide informed consent and comply with study procedures |
|
| ExclusionCriteria |
| Details |
History of recent orthopaedic surgery or injuries affecting muscle mass or fat distribution
Diagnosed with severe cardiovascular, respiratory, or neurological diseases that could affect body composition or the ability to perform measurements
Diagnosed with severe cognitive impairments that hinder understanding instructions or cooperation
Currently enrolled in another study that could influence body composition or measurement outcomes |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Comparison of body fat percentage measured by Bioelectrical Impedance Analysis BIA and Skinfold Thickness method.
Comparison of muscle mass measured by Bioelectrical Impedance Analysis BIA and Skinfold Thickness method.
Accuracy of both methods BIA and Skinfold in identifying older adults at risk of sarcopenia. |
Single baseline assessment single visit. All measurements will be taken on the same day for each participant. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="112"
Sample Size from India="112"
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)
|
25/11/2025 |
| 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 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
|
This study aims to evaluate the concurrent validity of bioelectrical impedance analysis BIA and skinfold thickness measurements for assessing muscle mass and distribution in older adults at risk of sarcopenia. The study will compare both methods to determine their accuracy, reliability, and applicability in clinical and community settings.
|