| CTRI Number |
CTRI/2025/07/092078 [Registered on: 31/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Yoga for Sarcopenia: A Randomized Controlled Trial |
|
Scientific Title of Study
|
Effect of Yoga Intervention on Functional Performance in Elderly with
Sarcopenia: A Prospective 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 |
Sumit |
| Designation |
PhD Scholar |
| Affiliation |
AIIMS Rishikesh |
| Address |
6th Floor, Department of Geriatric Medicine, AIIMS Rishikesh, 249203, Uttarakhand
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9084389392 |
| Fax |
|
| Email |
Sumitbhardwaaj1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sumit |
| Designation |
PhD Scholar |
| Affiliation |
AIIMS Rishikesh |
| Address |
6th Floor, Department of Geriatric Medicine, AIIMS Rishikesh, 249203, Uttarakhand
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9084389392 |
| Fax |
|
| Email |
Sumitbhardwaaj1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Monika Pathania |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Rishikesh |
| Address |
6th Floor, Department of Geriatric Medicine, AIIMS Rishikesh, 249203, Uttarakhand
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8126021556 |
| Fax |
|
| Email |
anshupathania27@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences · Virbhadra Road, Rishikesh · Uttarakhand- 249203, India |
|
|
Primary Sponsor
|
| Name |
AIIMS Rishikesh |
| Address |
Virbhadra Marg, Rishikesh, Uttarakhand, 249203 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Monika Pathania |
AIIMS Rishikesh |
Virbhadra Marg, Rishikesh, Uttarakhand, 249203
Dehradun
UTTARANCHAL |
8126021556
anshupathania27@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Rishikesh Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M628||Other specified disorders of muscle, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
SE: Standard Exercise |
The standard exercise module has been derived and verified by a PMR specialist, focusing on low- to moderate-intensity stretching, balancing, resistance, and aerobic exercises, with the same duration as the yoga intervention |
| Intervention |
YI: Yogic intervention |
The proposed yogic intervention involves a 45-minute session of low to moderate intensity yoga
practices including physical postures(padmasadhana series), breathing exercises, and meditation.
Participants will initially attend three consecutive offline sessions of 120 minutes each, led by a
certified trainer, to learn the practices. They will then practice at home and receive online follow-ups
to address any issues and ensure compliance. Duration of the intervention period would be 3 months with 6 days practice in a week. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Age Group/Gender- 60 to 70 yr, Male & Female
2. Having SARC-F score greater or equal to 4 (possible sarcopenia) and sarcopenia, as per the AWGS 2019 community guidelines
3. Subjects practicing less than 150 min. of exercise per week
4. Willing to comply with the study procedures and provide a written informed consent |
|
| ExclusionCriteria |
| Details |
1. Known cases of chronic kidney disease, chronic liver disease, primary malignancy, osteoarthritis, uncontrolled diabetes ,uncontrolled hypertension, HIV, on ICD and stroke.
2. Diagnosed cases of psychiatric disorders like severe depression, schizophrenia.
3. Active infections or sepsis.
4. Recent trauma, fractures, major surgeries (CABG, lower limb hip or knee replacement, renal
transplants ), musculoskeletal pains or any dysfunction that prevents physical activity.
5. Subjects on anabolic steroids, glucocorticoids, chemotherapy, antituberculosis drugs and thyroxine. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Physical Performance
Evaluated by Short Physical Performance Battery (SPPB) |
Day 0 (baseline), Day 45 (midpoint),
and Day 90 (post-intervention) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Muscle Mass: Appendicular skeletal muscle mass (ASM) measured via bioelectrical
impedance analysis (BIA) |
Day 0 (baseline), Day 45 (midpoint),
and Day 90 (post-intervention) |
| Muscle Strength: Maximum grip strength measured using a calibrated hand dynamometer. |
Day 0 (baseline), Day 45 (midpoint),
and Day 90 (post-intervention) |
Muscle Stem cell activation:
Concentration of PAX7 & MYF5 protein (ng/mL) in serum, measured via ELISA |
Day 0 (baseline) and Day 90 (post-intervention) |
Cognitive Assessment:
MoCA questionnaire: Montreal Cognitive assessment questionnaire based
assessment of cognition |
Day 0 (baseline), Day 45 (midpoint),
and Day 90 (post-intervention |
Quality of Life: Questionnaire based assessment of quality of life, using Sarcopenia related
quality of life (SarQoL) questionnaire |
Day 0 (baseline), Day 45 (midpoint), and Day 90 (post-intervention) |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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)
|
01/10/2025 |
| 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="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 - NO
|
|
Brief Summary
|
The study will be conducted in 2 phases. Phase 1 will be a pilot study to check the feasibility of the intervention. In the first year of the trial, necessary approvals from the ethics committee will be obtained, the trial will be prospectively registered with CTRI, and required equipment will be procured. Participant recruitment will begin, where each eligible participant will be screened based on eligibility criteria at the study settings, informed consent will be obtained, and baseline data will be collected. The participant will then undergo a three-month intervention with regular monitoring and follow ups to ensure adherence. Data will be collected at Day 0 (baseline), Day 45 (midpoint), and Day 90 (post-intervention) to assess changes throughout the intervention. This process will continue throughout the second and third years until the required sample size is achieved. Simultaneously data collection, monitoring and follow up will be ongoing. In the final year, the complete dataset will undergo statistical analysis, results will be interpreted, and findings will be disseminated through publications and conference presentations. |