| CTRI Number |
CTRI/2025/02/080712 [Registered on: 17/02/2025] Trial Registered Prospectively |
| Last Modified On: |
15/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
prevalence of sarcopenia and obesity |
|
Scientific Title of Study
|
Prevalence of Sarcopenic Obesity in kolar district- An Observational study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| not applicable |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Fahamidha B |
| Designation |
Master of physiotherapy |
| Affiliation |
R L Jalappa college of physiotherapy |
| Address |
R L Jalappa college of physiotherapy, SDUAHER
Department of Physiotherapy
Kolar
KARNATAKA
563103
India |
| Phone |
8903875022 |
| Fax |
|
| Email |
fahamidha1201@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Senthil Kumar Elumalai |
| Designation |
PhD in physiotherapy |
| Affiliation |
R L Jalappa college of physiotherapy |
| Address |
R L Jalappa college of physiotherapy, SDUAHER
Department of physiotherapy
Kolar
KARNATAKA
563103
India |
| Phone |
7276408001 |
| Fax |
|
| Email |
senthilekumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Senthil Kumar Elumalai |
| Designation |
PhD in physiotherapy |
| Affiliation |
R L Jalappa college of physiotherapy |
| Address |
R L Jalappa college of physiotherapy,SDUAHER
Department of physiotherapy
Kolar
KARNATAKA
563103
India |
| Phone |
7276408001 |
| Fax |
|
| Email |
senthilekumar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Devaraj Urs Academy of Higher Education and Research |
|
|
Primary Sponsor
|
| Name |
sri devaraj urs academy of higher education and research |
| Address |
R L Jalappa college of physiotherapy, sri devaraj urs academy of higher education and research, tamaka karnataka 563103 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Fahamidha B |
sir devaraj academy of higher education and research |
R L Jalappa college of physiotherapy, sir devaraj academy of higher education and research
department of physiotherapy tamaka 563103
Kolar
KARNATAKA |
8903875022
fahamidha1201@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| central ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
OBESITY
SARCOPENIA |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
not appalicable |
not applicable |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
all individual willing to participate |
|
| ExclusionCriteria |
| Details |
Participate unable to walk, not cooperative, who is very fragile, having cardiopulmonary, neurological and arthritis problems and who is taking medication that leads to obesity |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| muscle strength handheld dyno meter, 4m gait speed test, bioelectrical impedance analysis, skin fold caliper |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| not applicable |
not applicaple |
|
|
Target Sample Size
|
Total Sample Size="390"
Sample Size from India="390"
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)
|
03/03/2025 |
| 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
|
Participates will be screened using SARC-F questionnaire to rule out sarcopenia and they will be assessed for muscle strength using handheld dynamometer , assessed for gait speed using 4M gait speed test, and Bioelectrical impedance analysis is used to evaluate muscle mass and fat free mass and lastly skin fold calibre is used Gathering all dates, after statistical measurement, prevalence report is made
|