CTRI Number |
CTRI/2025/05/087704 [Registered on: 27/05/2025] Trial Registered Prospectively |
Last Modified On: |
26/05/2025 |
Post Graduate Thesis |
Yes |
Type of Trial |
Observational |
Type of Study
|
Cross Sectional Study |
Study Design |
Other |
Public Title of Study
|
Finding the link between Sarcopenia, Kinesiophobia and Frailty in Older Adults |
Scientific Title of Study
|
Association between Sarcopenia, Kinesiophobia and Frailty in Older Adults |
Trial Acronym |
NIL |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Mohammed Kareem Ruman |
Designation |
PG Student |
Affiliation |
Father Muller college of physiotherapy |
Address |
Anand Rao Badavane, Anna nagar 1st cross opp Vidhyodaya school
Shimoga Father Muller college of physiotherapy, Kankanady, Manglore Dakshina Kannada KARNATAKA 577201 India |
Phone |
7411917553 |
Fax |
|
Email |
mohammedkruman@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Leah Mohandas |
Designation |
Professor |
Affiliation |
Father Muller college of physiotherapy |
Address |
Father Muller college of physiotherapy, Kankanady, Manglore
Dakshina Kannada KARNATAKA 575002 India |
Phone |
9739863768 |
Fax |
|
Email |
leahdas86@fathermuller.in |
|
Details of Contact Person Public Query
|
Name |
Leah Mohandas |
Designation |
Professor |
Affiliation |
Father Muller college of physiotherapy |
Address |
Father Muller college of physiotherapy, Kankanady, Manglore
Dakshina Kannada KARNATAKA 575002 India |
Phone |
9739863768 |
Fax |
|
Email |
leahdas86@fathermuller.in |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
Mohammed Kareem Ruman |
Address |
Anand Rao Badavane, Anna Nagar 1st Cross opp Vidhyodaya School Shimoga |
Type of Sponsor |
Other [Self] |
|
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 |
Mohammed Kareem Ruman |
Father Muller Physiotherapy OPD (OPD No 10), IPD (R Ward) |
Father Muller Medical College Hospital Kankanady Mangaluru Dakshina Kannada KARNATAKA |
7411917553
mohammedkruman@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Father Muller Institutional Ethics Committee (FMIEC) |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, (2) ICD-10 Condition: M799||Soft tissue disorder, unspecified, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Nil |
Nil |
Intervention |
Nil |
Nil |
|
Inclusion Criteria
|
Age From |
65.00 Year(s) |
Age To |
85.00 Year(s) |
Gender |
Both |
Details |
Simple questionnaire to rapidly diagnose sarcopenia (SARC-F) score more than and equal to 4
Individuals able to walk independently
|
|
ExclusionCriteria |
Details |
Individuals with vestibular disorders
Individuals with neurological impairments
Individuals with cognitive impairment
Individuals unwilling to participate
Individuals with cardiovascular disorders
History of recent surgery (upper limb, lower limb and spine surgery in last 6 Month)
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
European working group on sarcopenia in old adults (EWGSOP2) criteria
Tampa scale of kinesiophobia (TSK- 17) |
20 min |
|
Secondary Outcome
|
Outcome |
TimePoints |
Fried frailty phenotype criteria |
15 min
5 questions
Total score-5/5 |
|
Target Sample Size
|
Total Sample Size="79" Sample Size from India="79"
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)
|
10/06/2025 |
Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
Date of First Enrollment (Global) |
10/06/2025 |
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
|
Sarcopenia is progressive loss of skeletal
muscle mass and muscle strength.
It carries a higher
risk of physical impairment,
lower quality of life, pain and
mortality. Sarcopenia is leading to increased frailty and
adverse health outcome. Frailty is commonly seen
in 5% to 17% of older population.
It is characterized by increased risk
of falls, hospitalizations, mortality and
various health domains vulnerability. Evidence suggests relationship between
frailty and sarcopenia is leading cause of reduced muscle function and
increased frailty and vice versa which accelerates functional deterioration in
older population. Kinesiophobia is an debilitating and irrational fear to carry out movement
due to pain or fear of injury2. Fear of
movement can lead to reduced activity and muscle atrophy, thereby increasing
the risk of frailty and sarcopenia. Fear of movement decreases physical
activity and function, which is necessary for older population to maintain healthy muscles. Due to increase in prevalence of sarcopenia and frailty in older
population, there is limited evidence investigating the relation between
frailty, sarcopenia and kinesiophobia. Understanding the relation between
frailty, kinesiophobia and sarcopenia in older population is essential as it can lead to reduced
mobility, physical function, increases the risk of fracture
and adverse health outcome. |