| CTRI Number |
CTRI/2025/12/099368 [Registered on: 18/12/2025] Trial Registered Prospectively |
| Last Modified On: |
17/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
STUDYING WHETHER ADDING VALIDATED YOGA TO USUAL TREATMENT CAN IMPROVE HBAIC,FBS VALUE AND QUALITY OF LIFE IN OLDER ADULTS. |
|
Scientific Title of Study
|
EFFECTIVENESS OF YOGA AS AN ADJUVANT THERAPY ON GLYCEMIC CONTROL AND QUALITY OF LIFE AMONG OLDER ADULTS WITH TYPE 2 DIABETES MELLITUS-A PILOT RANDOMIZED CONTROLLED TRIAL. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR BHAGYASHREE TANWAR |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPARTMENT OF GERIATRIC MEDICINE,AIIMS RISHIKESH,UTTARAKHAND, VIRBHADRA ROAD,RISHIKESH,249203,INDIA.
A5 DIVINE TOWER, NEAR VIRBHADRA ROAD, BARRAGE COLONY, RISHIKESH, 249201, INDIA.
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9929972543 |
| Fax |
|
| Email |
bhagyashreetanwar543@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MONIKA PATHANIA |
| Designation |
DEPARTMENT OF GERIATRIC MEDICINE , ADDITIONAL PROFESSOR |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
| Address |
A5 DIVINE TOWER, NEAR VIRBHADRA ROAD,BARRAGE COLONY,RISHIKESH ,249203,India.
DEPARTMENT OF GERIATRIC MEDICINE, AIIMS RISHIKESH, UTTARAKHAND, VIRBHADRA ROAD,RISHIKESH,249203,INDIA.
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8126021556 |
| Fax |
|
| Email |
anshupathania27@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR MONIKA PATHANIA |
| Designation |
DEPARTMENT OF GERIATRIC MEDICINE , ADDITIONAL PROFESSOR |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
| Address |
A5 DIVINE TOWER, NEAR VIRBHADRA ROAD, BARRAGE COLONY,RISHIKESH, 249201, INDIA.
DEPARTMENT OF GERIATRIC MEDICINE, AIIMS RISHIKESH, UTTARAKHAND, VIRBHADRA ROAD,RISHIKESH,249203,INDIA.
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8126021556 |
| Fax |
|
| Email |
anshupathania27@gmail.com |
|
|
Source of Monetary or Material Support
|
| ALL INDIA INSTITUTE OF MEDICAL SCIENCES,AIIMS RISHIKESH,UTTARAKHAND,249203,INDIA. |
|
|
Primary Sponsor
|
| Name |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
| Address |
DEPARTMENT OF GERIATRIC MEDICINE,AIIMS RISHIKESH,UTTARAKHAND, VIRBHADRA ROAD,RISHIKESH,249203,INDIA. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 BHAGYASHREE TANWAR |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
DEPARTMENT OF GERIATRIC MEDICINE,AIIMS RISHIKESH , UTTARAKHAND,VIRBHADRA ROAD, RISHIKESH,249203,INDIA.
Dehradun
UTTARANCHAL |
09929972543
bhagyashreetanwar543@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
STANDARD THERAPY-ORAL HYPOGLYCEMIC AGENT |
STANDARD THERAPY RECOMMENDED FOR DIABETES MELLITUS AS PER LATEST ADA 2026 GUIDELINES. |
| Intervention |
The 12-week Structured Validated Yoga Intervention Therapy. |
Participants in the intervention group will receive a standardized yoga mudule designed for older adults with type 2 Diabetes mellitus. The module includes pranayama breathing exercise , joint loosening exercise, asanas and relaxation and meditation exercise. Supervised session by qualified yoga instructor with home practice encouragement on non- supervised days. All participants will continued their oral hypoglycaemic drugs for diabetes mellitus as prescribe by treating clinician. No other additional therapy will be added. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of age more than 60 years or older.
2. Patient with diagnosis of Type 2 Diabetes Mellitus for at least 1 year.
3. Patients having scores less than 7 as per Clinical Frailty Scale (CFS).
4. Patients must be physically capable of participating in yoga sessions, including the ability to perform basic physical movements and tolerate moderate physical exertion.
5. Patients willing to participate in the study by giving consent. |
|
| ExclusionCriteria |
| Details |
1. Patients with medical conditions severity of which may significantly impact their ability to participate in the yoga intervention such as ischemic heart disease, malignancy, neurodegenerative disorder, oxygen dependent lung disease, severe musculoskeletal disorders.
2. Patient with HBAIC more than 10,
3. Patient who are active smoker,
4. Patients with cognitive impairment with a HMSE score of less than 19.
5. Patients with a visual acuity of less than 6/60 with correction.
6. Patients with moderate to severe hearing impairment.
7. Patients with known psychiatric disorders and who are under current treatment for the same conditions for at least 3 months.
8. Participation in any other exercise program or intervention that could confound results.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| At the end of three months, to see change in fasting blood sugar, post prandial blood sugar and HbA1C levels. |
three months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Improvement in quality of life after three months of structured yoga therapy
2. Improvement in sleep quality after three months of structured yoga therapy
3. To see reduction of dosing requirement of anti-diabetic medications after three months of yoga therapy. |
three months |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
01/01/2026 |
| 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="1"
Months="6"
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 geriatric population is defined as
population aged 60 years and above. This ageing, at biological level results from the
impact of accumulation of a wide variety of molecular and cellular damage over
time which leads to gradual decrease in physical and mental capacity and
deterioration of organ systems in the body leading to increase in risk of
ailments. Diabetes mellitus (DM), particularly Type 2
Diabetes, has become a major global health challenge, with older adults being
especially vulnerable to its complications. Type 2 diabetes mellitus (T2DM) is
a common metabolic disorder characterized by chronic hyperglycemia. According to the World Health Organization
(WHO), the global prevalence of diabetes among adults aged 60 years and above
is rising steadily, making it one of the leading causes of morbidity and
mortality in this population. Older adults with diabetes are at increased risk
of both acute and chronic complications, such as cardiovascular disease,
neuropathy, kidney failure, and poor quality of life (QoL). Most patients with
T2DM display dyslipidemia, hypertension and hyperinsulinemia, which are
associated with metabolic syndrome and will lead to an increased risk of
premature cardiovascular disease. Managing glycemic control effectively is
crucial to preventing these complications and improving the overall health and
well-being of older individuals living with diabetes. Conventional management of diabetes primarily
focuses on pharmacological treatments, such as insulin and oral hypoglycemic
agents, alongside lifestyle modifications like diet and exercise. However,
despite these efforts, many older adults struggle with optimal glycemic
control, often due to challenges such as polypharmacy, physical limitations,
and reduced ability to exercise. India there is a rich history of using yoga to
manage T2DM. Yoga is a mind/body practice based on traditional Indian
philosophy, often incorporating three major components: held or sequences of
physical postures, breathing exercises and meditation. Previous studies have
shown that yoga can have beneficial effects on blood glucose levels, reduce
stress, improve physical fitness, and enhance psychological well-being.
However, while yoga has been widely explored as a complementary treatment for
diabetes, few studies have specifically focused on older adults, a population
with unique health challenges and considerations. Given the potential benefits of yoga and the
increasing burden of diabetes in older adults, it is essential to investigate
whether yoga can be an effective intervention for improving glycemic control
and quality of life in this demographic. The results of such studies could not
only expand our understanding of yoga as an adjuvant therapy but also
contribute to developing holistic, person-centered care strategies for managing
diabetes in older adults. |