| CTRI Number |
CTRI/2023/09/057819 [Registered on: 18/09/2023] Trial Registered Prospectively |
| Last Modified On: |
16/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Relationship between lower extremity muscle mass, peak isometric torque, and functional performance in community-dwelling geriatric population. |
|
Scientific Title of Study
|
Relationship between lower extremity muscle mass, peak isometric torque, and functional performance in community-dwelling geriatric population. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ann Merina Mathew |
| Designation |
PG student |
| Affiliation |
Kasturba medical college,Department of Physiotherapy,Mangalore. |
| Address |
Kasturba medical college ,
Department of Physiotherapy
Bejai,Mangalore,Dakshina Kannada-575004.
Karnataka
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
9137873384 |
| Fax |
|
| Email |
annmathew1099@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Shyam Krishnan K |
| Designation |
Assistant Professor -senior scale |
| Affiliation |
Kasturba Medical College,Department of Physiotherapy,Mangalore |
| Address |
Kasturba medical college ,
Department of Physiotherapy
Bejai,Mangalore,Dakshina Kannada-575004.
Karnataka
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
9137873384 |
| Fax |
|
| Email |
krish.shyam@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Mr Shyam Krishnan K |
| Designation |
Assistant Professor -senior scale |
| Affiliation |
Kasturba Medical College,Department of Physiotherapy,Mangalore |
| Address |
Kasturba medical college ,
Department of Physiotherapy
Bejai,Mangalore,Dakshina Kannada-575004.
Karnataka
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
9137873384 |
| Fax |
|
| Email |
krish.shyam@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College,Mangalore |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College,Mangalore |
| Address |
Kasturba medical college ,
Department of Physiotherapy
Bejai,Mangalore,Dakshina Kannada-575004.
Karnataka |
| 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 |
| Ann Merina Mathew |
Kasturba Medical College Hospital,Attavar |
Department of Physiotherapy,Room No. 22.
Dakshina Kannada
KARNATAKA |
9137873384
annmathew1099@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Kasturba Medical College,Mangalore. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z729||Problem related to lifestyle, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Community-dwelling elderly subjects of either gender in the age group of 60 and above.
Ability to ambulate independently without assistive devices.
|
|
| ExclusionCriteria |
| Details |
Any neurological, musculoskeletal, or cardiovascular conditions (for eg. stroke) that contraindicate the outcome assessments and confound to muscle loss, muscle strength, and functional performance.
Cognitive impairment indicated by a MoCA score of less than 26.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluating the relationship between muscle mass, muscle strength and functional performance in community-dwelling elderly would be instrumental in devising evaluation protocols which reflect the relationship between these variables. |
One time evaluation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
30/09/2023 |
| 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 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
|
In this study, Analysis of body composition such as body weight,body fat percentage,BMI,segmantal subcutaneous fat,skeletal muscle percentage,resting metabolism,visceral fat level, and body age will be done using KARADA Bio-electrical Impedance Analyser. Measurement of lower extremity muscle group strength will be done using a MicroFET handheld Dynamometer. Subjects will be assessed for functional performance using the Senior Fitness Test and Short Physical Performance Battery. The data collected will be statistically analysed and the results interpreted will be measured accordingly. The study helps in understanding the relationship between functional performance and variables of muscle strength and body composition in community-dwelling elderly. |