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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  
NIL 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 musclesDue 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.

 
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