| CTRI Number |
CTRI/2024/09/073940 [Registered on: 13/09/2024] Trial Registered Prospectively |
| Last Modified On: |
30/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To evaluate aging related muscle mass reduction among older adults in the community |
|
Scientific Title of Study
|
sarcopenia and related factors among the community dwelling older adults findings of a cross sectional study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Balamurugan janakiraman |
| Designation |
professor |
| Affiliation |
SRM institute of science and technology |
| Address |
rooon no PT29 4th floor SRM college of physiotherapy SRM medical college hospital and research centre SRM nagar potheri kattankulathur chengalpattu kanchipuram
TAMIL NADU
603203
India
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9941215503 |
| Fax |
|
| Email |
bala77physio@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Balamurugan janakiraman |
| Designation |
professor |
| Affiliation |
SRM institute of science and technology |
| Address |
rooon no PT29 4th floor SRM college of physiotherapy SRM medical college hospital and research centre SRM nagar potheri kattankulathur chengalpattu kanchipuram
TAMIL NADU
603203
India
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9941215503 |
| Fax |
|
| Email |
bala77physio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Balamurugan janakiraman |
| Designation |
professor |
| Affiliation |
SRM institute of science and technology |
| Address |
rooon no PT29 4th floor SRM college of physiotherapy SRM medical college hospital and research centre SRM nagar potheri kattankulathur chengalpattu kanchipuram
TAMIL NADU
603203
India
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9941215503 |
| Fax |
|
| Email |
bala77physio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no PT05 5th floor
SRM college of physiotherapy
SRM medical college hospital and research centre
srm nagar
potheri
kattankulathur campus
chengalpattu district
Tamil nadu 603203 |
|
|
Primary Sponsor
|
| Name |
SRM institute of science and technology |
| Address |
Room no PT05 5th floor
SRM college of physiotherapy
SRM medical college hospital and research centre
srm nagar
potheri
kattankulathur campus
chengalpattu district
Tamil nadu 603203 |
| 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 |
| balamurugan janakiraman |
kattankulathur community |
potheri kattankulathur (po) chengalpattu district chennai tamilnadu 603203
Kancheepuram
TAMIL NADU |
9941215503
bala77physio@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM medical college hospital and research centre Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
sarcopenia |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
55.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
clients above 55 years
patients without conginitive impairments |
|
| ExclusionCriteria |
| Details |
clients below 55 years
patients with cognitive impairment
paralyzed patients
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Handheld dynamometer |
Baseline
at 6 weeks
at 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
SARC F questionnaire
|
baseline
at 6 weeks
at 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="805"
Sample Size from India="805"
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)
|
15/09/2024 |
| 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 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
|
Aim is to to determine the prevalence of sarcopenia using SARC-CALF SARC-F Hand grip strength and identify the factors related among community dwelling geriatric population Sarcopenia is associated with a high risk of a wide range of adverse health outcomes.Physical inactivity malnutrition smoking extreme sleep duration and diabetes are related to sarcopenia Community-based epidemiological studies are needed to better understand the predictors/factors related/causes of sarcopenia
Study design/type: community based cross sectional study / non experimental study
Sampling method: Multi stage random sampling method
Study setting: Administrative zones of Potheri village will be conveniently selected henceforth multi-stage random sampling will be employed to identify household with older adults sample size is 805 outcome measures going to use are Hand held dynamometer (camry) SARC–F questionnaire SARC –calf score Mechanical scale with stadiometer attached The findings of this study would definitely bring to light the burden of one of the serious adverse health conditions among the aging population Sarcopenia Furthermore, this study will also explore the possible predictors or factors associated with sarcopenia using the regression model
|