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CTRI Number  CTRI/2024/07/071003 [Registered on: 22/07/2024] Trial Registered Prospectively
Last Modified On: 20/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To analyze the effects of virtual reality training on muscle mass and balance component in subjects with sarcopenia. 
Scientific Title of Study   Effects of virtual reality training on muscle mass and balance parameters among elderly sarcopenic individuals with fall risk 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
nil   NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SHARMILA S  
Designation  Assistant professor 
Affiliation  vels institute of science and technology 
Address  School of Physiotherapy, Vels institute of science and technology, Room no: PH215 thalambur division, kancheepuram, tamil nadu,India.

Kancheepuram
TAMIL NADU
600130
India 
Phone  9789183568  
Fax    
Email  sharmila.sp@velsuniv.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Dr. senthil selvam.P  
Designation  Professor and Head of the department 
Affiliation  vels institute of science and technology 
Address  school of physiotherapy, vels institute of science and technology, room no: PH215 thalambur division, kancheepuram,tamil nadu, India.

Kancheepuram
TAMIL NADU
600130
India 
Phone  9444309160  
Fax    
Email  hodphysiotherapy@velsuniv.ac.in  
 
Details of Contact Person
Public Query  
Name  SHARMILA S  
Designation  Assistant professor 
Affiliation  vels institute of science and technology 
Address  School of Physiotherapy, Vels institute of science and technology, room no: PH215 thalambur division, kancheepuram,tamil nadu, India.

Kancheepuram
TAMIL NADU
600130
India 
Phone  9789183568  
Fax    
Email  sharmila.sp@velsuniv.ac.in  
 
Source of Monetary or Material Support  
shri ishari velan mission hospital, thalambur, chengalpattu district, 603103, tamil nadu, India. and JK physio and rehab clinic, thirumangalam, chennai, 600040 tamil nadu, India. 
 
Primary Sponsor  
Name  sharmila s 
Address  school of physiotherapy, Vels institute of science and technology. room no: PH215,kancheepuram district, thalambur division 603103, tamil nadu, India. 
Type of Sponsor  Other [self ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
sharmila  JK physio and rehab clinic  JK physio and rehab clinic, Physiotherapy department, 3rd floor, virtual reality lab room NO: 105, Tirumangalam division 600040.
Chennai
TAMIL NADU 		 9789183568

sharmilasubramani25@gmail.com 
sharmila  sri ishari vellan mision hospital  sri ishari vellan mission hospital, Physiotherapy department ground floor physiotherapy OPD, and research lab room NO: PHY214, thalambur division. 603103
Kancheepuram
TAMIL NADU 		 9789183568

sharmilasubramani25@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
JK physio and rehab clinic  No Objection Certificate 
Sri ishari vellan mission hospital  No Objection Certificate 
Vels institute of science and technology and advanced studies school of pharmaceutical science institutional ethical commitee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M629||Disorder of muscle, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  resistance and balance training with minimal weights will be adminstered.  21 samples who fulfilled their inclusion and exclusion criteria will be randomly assigned in to a group and will recieve resistance and balance training exercises with minimal weights for the period of 12 weeks 3 days per week. 
Intervention  virtual reality based exercises resistance exercises abd balance exercises will be   21 samples who fullfilled the inclusion and exclusion criteria will be randomly assigned in to a group which will recieve virtual reality based resistance and balance training for 12 weeks for 3 days per week. 
 
Inclusion Criteria  
Age From  65.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1 Older people with age group of 65 and above
2 SARC –F screening tool greater than 4 points (specificity: 0.90, sensitivity 0.21)
3 A muscle mass of lesser than 7.0 kg/m2 for men and 5.0 kg/m2 for women estimated using bio -impedance analysis,
Hand grip strength lesser than 26 kg for men and 18 kg for women
4 Usual gait speed of lesser than 0.8m/sec
5 Not engaging in an exercise program or receiving exercise guidance. 
 
ExclusionCriteria 
Details  1 History of deep venous thrombosis and/or blood clotting disorders
2 Those who had significant cardiopulmonary diseases and received oxygen supplementation.
3 Uncontrollable hypertension
4 Experienced a recent infection, or were diagnosed with other diseases and prohibited to participate in sports exercise according to the guidelines of the American College of Sports Medicine will be excluded.
5 Patients who could not walk even with the use of assistive devices will be excluded from this study
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
bio impedance analyzer, EMG, Spring hand held dynamometer.  1st week, 6th week, 12th week 
 
Secondary Outcome  
Outcome  TimePoints 
berg balance scale, gait speed, time up and go test.  1st week, 6th week and 12th week. 
 
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)   31/07/2024 
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="3"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sharmila.sp@velsuniv.ac.in].

  6. For how long will this data be available start date provided 15-07-2024 and end date provided 14-10-2027?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
  There is reduction in muscle mass in sarcopenic patients results in reduction in the muscle strength and balance levels which in turn makes the elderly population to loss their balance and led to fall This may result in the limitation of patient’s independence and their long-term immobilization, which can predispose them to various complications and clinical pathologies. Still now there are of studies done in evaluating resistance training in sarcopenic subjects using high velocity tools but there are very limited evidences on evaluating balance and resistance training using virtual reality device.  Hence the purpose of the study is to focus on improving the appendicular skeletal muscle mass and balance in sarcopenic subjects using the new virtual reality technique which is shown to be effective in few studies.
 
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