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CTRI Number  CTRI/2025/07/090429 [Registered on: 08/07/2025] Trial Registered Prospectively
Last Modified On: 05/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Integrated Yoga ]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Yoga on Sarcopenia 
Scientific Title of Study   Impact of Integrated Yoga Module on Sarcopenia: A Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sandeep Kumar Singh 
Designation  Assistant Professor 
Affiliation  University of Patanjali 
Address  Office No. 2 Prachya Vidya Samkaya Department of Yoga Science University of Patanjali Haridwar

Hardwar
UTTARANCHAL
249405
India 
Phone  8946870057  
Fax    
Email  drsandeep@uop.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Sandeep Kumar Singh 
Designation  Assistant Professor 
Affiliation  University of Patanjali 
Address  Office No 2 Prachya Vidya Samkaya University of Patanjali Haridwar

Hardwar
UTTARANCHAL
249405
India 
Phone  8946870057  
Fax    
Email  drsandeep@uop.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Sandeep Kumar Singh 
Designation  Assistant Professor 
Affiliation  University of Patanjali 
Address  Office No 2 Prachya Vidya Samkaya University of Patanjali Haridwar

Hardwar
UTTARANCHAL
249405
India 
Phone  8946870057  
Fax    
Email  drsandeep@uop.edu.in  
 
Source of Monetary or Material Support  
University of Patanjali Haridwar Uttarakhand India 249405 
 
Primary Sponsor  
Name  University Grants Commission 
Address  Bahadur Shah Zafar Marg, New Delhi India 110002 
Type of Sponsor  Government funding agency 
 
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 Arvind Mathur  Dr. S. N. Medical College   Jodhpur
Jodhpur
RAJASTHAN 		 09536854586

mathurarvindju@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Commitee University of Patanjali  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M628||Other specified disorders of muscle,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Sukshma Vyayama, Asana, Pranayama, Meditation  IYMS will be given to the experimental group for 90 days. Each session will be for 60 minutes for 6 days excluding sunday. Timing will be 7 to 8 AM. 
Comparator Agent  Sukshma Vyayama, Asana, Pranayama, Meditation  IYMS would be given for 30 days after the post-test secured as a control for 90 days. Each session will be for 60 minutes for 6 days excluding sunday. Timing will be 7 to 8 AM. 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Diagnosis: Clinically diagnosed with sarcopenia based on criteria (low muscle strength, muscle quantity or quality and physical performance).
Mobility: Ability to walk independently or with minimal assistance.
Cognitive Function: Cognitively intact to follow instructions.
Consent: Willingness to participate with signed informed consent.
Stable Health: Medically stable with controlled chronic conditions
No Prior Yoga Experience: No regular yoga practice in past 6 months. 
 
ExclusionCriteria 
Details  Severe Musculoskeletal Disorders: Conditions limiting safe physical activity (such as severe arthritis, recent fractures).
Neurological Disorders: Diagnosed with Parkinson’s disease, stroke, or other conditions affecting balance/mobility.
Uncontrolled Chronic Diseases: Uncontrolled diabetes, hypertension, or heart conditions that increase risk during yoga.
Recent Surgery: Major surgery within the last 6 months.
Severe Cognitive Impairment: Diagnosed dementia or significant cognitive decline.
Psychiatric Conditions: Severe mental health disorders affecting participation.
Regular Engagement in Yoga: Active participation in structured yoga programs within the last 3 months. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
It is hypothesized that patients in experimental group are expected to show improvements in their muscle strength, muscle mass and physical performance.   90 days 
 
Secondary Outcome  
Outcome  TimePoints 
Regular yoga may show enhanced quality of life in patients of experimental group.  90 days 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   01/09/2025 
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="0"
Months="6"
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 -  Statistical Analysis Plan
    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 - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [drsandeep@uop.edu.in].

  6. For how long will this data be available start date provided 01-09-2025 and end date provided 30-09-2030?
    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  

Sarcopenia is a musculoskeletal disease in which muscle mass, strength, and performance are significantly compromised with age, and restricts mobility and independence in an aging society. The diagnosis of sarcopenia encompasses decreased levels of the following 3 traits: muscle strength, muscle quantity or quality, and physical performance. The review of epidemiology studies from Asian countries that used AWGS 2014 criteria discovered that the prevalence of sarcopenia ranged from 5.5% to 25.7%, with male predominance (5.1%-21.0% in men vs 4.1%-16.3% in women). Prevalence of sarcopenia in India, according to a multi-continent study, was found to be 17.5%. Yoga is an ancient Indian technique of physical and mental discipline generally attributed to a group of scholars known by the name Patanjali. Studies show increased muscle mass, muscle strength and physical performance in elderly populations practicing yoga regularly.

 
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