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CTRI Number  CTRI/2021/06/034062 [Registered on: 08/06/2021] Trial Registered Prospectively
Last Modified On: 08/06/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To Study The Effect Of Resistance Training On Muscle Mass, Muscle Strength And Physical Performance In older Individuals With loss of muscle mass. 
Scientific Title of Study   effectiveness of resistance training on muscle mass and physical performance in individuals with sarcopenia : A randomized controlled trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  KAIRAVI KISHORBHAI TRIVEDI 
Designation  Assistant Professor 
Affiliation  Apollo Institute Of Physiotherpy 
Address  Ortho Division, Physiotherapy Department, Apollo Institute of Physiotherapy.
Apollo Institute Of Physiotherpy, SNME Campus, Naroda- Dahegam Road, Near SP ring road, Enasan, Ahmedabad.
Ahmadabad
GUJARAT
380015
India 
Phone  9428638232  
Fax    
Email  kairavitrivedi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  KAIRAVI KISHORBHAI TRIVEDI 
Designation  Assistant Professor 
Affiliation  Apollo Institute Of Physiotherpy 
Address  Apollo Institute Of Physiotherpy, Physiotherapy Department, Ortho Division.
Apollo Institute Of Physiotherpy, SNME Campus, Near SP ring road, Enasan, Ahmedabad.
Ahmadabad
GUJARAT
380015
India 
Phone  9428638232  
Fax    
Email  kairavitrivedi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Subhash M Khatri 
Designation  Principal 
Affiliation  Nootan College Of Physiotherapy 
Address  Physiotherapy Department, Principal Office, Nootan College Of Physiotherapy.
Nootan College Of Physiotherapy, Sankalchand Patel University, Visnagar, Mehsana.
Mahesana
GUJARAT
384315
India 
Phone  8830174477  
Fax    
Email  physiokhatri@gmail.com  
 
Source of Monetary or Material Support  
Apollo Institute Of Physiotherpy, SNME Campus, Naroda- Dahegam Road, Near SP ring road, Enasan, Ahmedabad. GUJARAT 380015  
 
Primary Sponsor  
Name  Kairavi Kishorbhai Trivedi 
Address  Apollo Institute of Physiotherapy, Physiotherapy divison, orthopedic department, SNME campus, Enasan, Ahmedabad. 380015 
Type of Sponsor  Other [Primary Investigator] 
 
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 
Dr Subhash M Khatri  Nootan College of Physiotherapy  Ortho Divison, Physiotherapy Department, Nootan College of Physiotherapy, Sankalchand Patel University, Visnagar, Gujarat.
Mahesana
GUJARAT 		 8830174477

physiokhatri@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Nootan College Of Physiotherapy  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Individuals with Sarcopenia 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Resisted Exercises for Calf Muscles.  Resistance Training in older sarcopenic individuals is widely recognized for improvements in muscle performance, functional activities and quality of life. This training is a non-pharmacological therapy which specifically improve muscle strength, power or endurance. resistance exercise will be given 3 sessions per week for 2 weeks. each session consist of 40 minutes.  
Comparator Agent  walking activity and general advice for health  walking activity include major lower limb muscles which maintain general health and physical fitness of body. walking activity will be advised for 20 minutes daily for 2 weeks. 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  - Muscle mass with Bioimpedance Analysis
[<7.0 kg/m2 for men,<5.7 kg/m2 for women.]
- Hand grip strength
[<28 kg for men,<18 kg for women.]
- Short Physical Performance Battery score ≤ 9.
 
 
ExclusionCriteria 
Details  - Person with non-ambulatory phase.
- Person with any neurological disorders like stroke, parkinsonism, ataxia.
- Person have acute cardiac disease.
- Uncontrolled diabetes.
- Not willing to participate in the study.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Muscle thickness or Muscle Cross sectional area by muscle sonography  at the beginning of the study and after 2 month period. 
 
Secondary Outcome  
Outcome  TimePoints 
Muscle Girth measurement by Girth measurement technique.  at the beginning of the study and after 2 month period. 
Physical Performance by Short Physical Performance Battery - (SPPB tool)  at the beginning of the study and after 2 month period. 
SARC-F Questionnaire for screening sarcopenia.  at the beginning of the study and after 2 month period. 
muscle strength  at the beginning of the study and after 2 month period. 
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
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)   01/08/2021 
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="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not done any publication yet. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   After 1 April 2021, participant recruitment will be start according to planned inclusion and exclusion criteria. Written informed consent form will be taken from the participants. Participants will be randomly allocated into intervention and control group. Pre-intervention all outcome measures will be measured by blinded outcome measure assessor. Intervention group will be given resistance training for 40-50 minutes 3 days a week for 2 months. Control group will be given advice to maintain physical health and walking activity daily for 20 minutes for 2 months. At the end of 2 month time period post-intervention all outcome measures will be measured by same technique. The data will be analyzed by SPSS software. Study will be done to check the effect of resistance training exercise on muscle cross sectional area, muscle girth, physical performance in individuals with sarcopenia. 
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