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CTRI Number  CTRI/2026/01/100569 [Registered on: 08/01/2026] Trial Registered Prospectively
Last Modified On: 07/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA)
Other (Specify) [Tailored Exercise regimen]  
Study Design  Other 
Public Title of Study   The Effectiveness of an Exercise regimen to Improve Sarcopenia, Sarcopenic Obesity, and Myokine Levels in Rheumatoid Arthritis 
Scientific Title of Study   A Study to Estimate the Efficacy and Duration of Tailored Exercise to Improve Sarcopenia, Sarcopenic Obesity, and Myokine Levels in Rheumatoid Arthritis 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Varsha Bhatt 
Designation  Professor Department of Clinical Immunology and Rheumatology 
Affiliation  Bharati Vidyapeeth (Deemed to Be) University Medical College and Hospital ,Pune 
Address  Department of Clinical Immunology and Rheumatology, th floor, Bharati Vidyapeeth (DTU) Medical College and Hospital Dhankawadi,Pune
Dhankawadi Pune Satara Road, Pune 411043
Pune
MAHARASHTRA
411043
India 
Phone  9405580574  
Fax    
Email  drvrbhatt@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Varsha Bhatt 
Designation  Professor, Department of Clinical Immunology and Rheumatology 
Affiliation  Bharati Vidyapeeth (Deemed to Be) University Medical College and Hospital ,Pune 
Address  Bharati Hospital Dhankawadi Pune
Dhankawadi Pune Satara Road, Pune 411043
Pune
MAHARASHTRA
411043
India 
Phone  8484056341  
Fax    
Email  varsha.rajat@bharatividyapeeth.edu  
 
Details of Contact Person
Public Query  
Name  Dr Varsha Bhatt 
Designation  Professor Department of Clinical Immunology and Rheumatology 
Affiliation  Bharati Vidyapeeth (Deemed to Be) University Medical College and Hospital ,Pune 
Address  Bharati Hospital, Dhankawadi Pune
Dhankawadi Pune Satara Road, Pune 411043
Pune
MAHARASHTRA
411043
India 
Phone  9405580574  
Fax    
Email  drvrbhatt@gmail.com  
 
Source of Monetary or Material Support  
Central research and publication unit (CRPU), Bharati Vidyapeeth (DTU) Medical College and Hospital, Dhankawadi, Pune- 411043 
 
Primary Sponsor  
Name  Central Research and Publication Unit 
Address  Bharati Vidyapeeth (DTU)Medical College and Hospital,Dhankawadi,Pune-411043 
Type of Sponsor  Private medical college 
 
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 Varsha Bhatt  Bharati Vidyapeeth Medical College  Department of Clinical Immunology and Rheumatology,OPD Number 37,38 Dhankawadi
Pune
MAHARASHTRA 		 9405580574

drvrbhatt@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE,BHARATI VIDYAPEETH(DTU)MEDICAL COLLEGE,PUNE-43  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M059||Rheumatoid arthritis with rheumatoid factor, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  NOT APPLICABLE 
Intervention  Tailored exercise regimen  Exercise regimen including a supervised strength training module, aerobic exercise and flexibility 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients of diagnosed RA ACR-EULAR 2010 Criteria
Sarcopenia as per AWGS criteria 
 
ExclusionCriteria 
Details  1.Diagnosed cases of end stage chronic kidney disease , decompensated chronic liver disease, Heart failure, infections, COPD, interstitial lung disease with functional impairment, permanent neurological disorders, cancers, or on medication for these
2. ACR functional status class IV : Limited ability to perform usual self-care, work, and hobbies.
3. Overlap with other connective tissue disease
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the efficacy of a tailored exercise regimen on the muscle mass, fat mass, sarcopenia and sarcopenic obesity as assessed by Bioelectrical impedance analysis (BIA) and clinical measures in sarcopenic patients of rheumatoid arthritis  4 weeks, 8 weeks, 12 weeks, 16 weeks and 24 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
• To estimate levels of the myokine myostatin and exerkine irisin in this population pre and post intervention
• To determine the duration needed to achieve a change in the severity of sarcopenia
• To determine disease activity (DAS 28-CRP), fatigue (FACIT-F), disability (HAQ-DI), quality of life (EQ5D5L) pre and post the intervention
• To determine the associations between sarcopenia/sarcopenic obesity, disease parameters and myokine levels
 		 4 weekly muscle mass assessment
final time point-24 weeks 
 
Target Sample Size   Total Sample Size="235"
Sample Size from India="235" 
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)   02/02/2026 
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 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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drvrbhatt@gmail.com].

  6. For how long will this data be available start date provided 02-02-2026 and end date provided 01-02-2031?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

AIM:

To determine the efficacy of a tailored exercise regimen on the muscle mass, fat mass, sarcopenia and sarcopenic obesity in sarcopenic patients of rheumatoid arthritis

Primary objective: To determine the efficacy of a tailored exercise regimen on the muscle mass, fat mass, sarcopenia and sarcopenic obesity as assessed by Bioelectrical impedance analysis (BIA) and clinical measures in sarcopenic patients of rheumatoid arthritis

Secondary objectives:

·       To estimate levels of the myokine myostatin and exerkine irisin in this population pre and post intervention

·       To determine the duration needed to achieve a change in the severity of sarcopenia

·       To determine disease activity (DAS 28-CRP), fatigue (FACIT-F), disability (HAQ-DI), quality of life (EQ5D5L) pre and post the intervention

·       To determine the associations between sarcopenia/sarcopenic obesity, disease parameters and myokine levels

RESEARCH QUESTION: To determine the objective increase in appendicular skeletal muscle mass by Bioelectrical impedance analysis (BIA) in sarcopenic patients of rheumatoid arthritis when subjected to a tailored exercise regimen over and above standard of care

•       P :  Patients of diagnosed rheumatoid arthritis who have sarcopenia

•       I: Tailored graded exercise regimen (Strength training/ resistance training, aerobics and flexibility)

•       C: Same group after the intervention (Before and after)

•       O : Objective increase in muscle mass as measured by BIA

•       T: 24 weeks

 

 

 

 
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