| CTRI Number |
CTRI/2022/07/044442 [Registered on: 28/07/2022] Trial Registered Prospectively |
| Last Modified On: |
17/11/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Yoga for older adults |
|
Scientific Title of Study
|
Effectiveness of Yoga on Composite Biomarker Age Predictors
in an Elderly Indian Cohort-A Two Armed open label 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 |
Vijaya Majumdar |
| Designation |
Associate professsor |
| Affiliation |
SVYASA Deemed to be University |
| Address |
Prasanthi kutiram, SVYASA Yoga university, vivekananda road, kallabalu post, jigani, anekal
Prasanthi kutiram, SVYASA Yoga university, vivekananda road, kallabalu post, jigani, anekal
Bangalore
KARNATAKA
560105
India |
| Phone |
9036800821 |
| Fax |
|
| Email |
majumdar.vijaya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vijaya Majumdar |
| Designation |
Associate professsor |
| Affiliation |
SVYASA Deemed to be University |
| Address |
Prasanthi kutiram, SVYASA Yoga university, vivekananda road, kallabalu post, jigani, anekal
Prasanthi kutiram, SVYASA Yoga university, vivekananda road, kallabalu post, jigani, anekal
Bangalore
KARNATAKA
560105
India |
| Phone |
9036800821 |
| Fax |
|
| Email |
majumdar.vijaya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vijaya Majumdar |
| Designation |
Associate professsor |
| Affiliation |
SVYASA Deemed to be University |
| Address |
Prasanthi kutiram, SVYASA Yoga university, vivekananda road, kallabalu post, jigani, anekal
Prasanthi kutiram, SVYASA Yoga university, vivekananda road, kallabalu post, jigani, anekal
Bangalore
KARNATAKA
560105
India |
| Phone |
9036800821 |
| Fax |
|
| Email |
majumdar.vijaya@gmail.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Department of Science & Technology,
Technology Bhavan, New Mehrauli Road,,
New Delhi-110 016 |
|
|
Primary Sponsor
|
| Name |
DST SATYAM |
| Address |
Technology Bhavan, New Mehrauli Road, New Delhi-110 016. |
| 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 |
| Vijaya Majumdar |
Anweshana Research labaratory SVYASA Deemed to be university |
Division of yoga and life sciences, department of molecular bioscience lab, SVYASA Yoga university, Kallabalu post, Jigani, Anekal
Bangalore
KARNATAKA |
9036800821
majumdar.vijaya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee-SVYASA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
older adults aged 60-80 yrs |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Walking exercise |
NA |
| Intervention |
Yoga |
Validated yoga module for 1 year
1hr/day 5 days a week |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Willing to participate in the interventions
2. No presence of implanted devices or metallic bodies above the waist
3. No history of stroke or Transient ischemic attack (TIA)
4. Intention to remain in the local area for the duration of the intervention or testing period
|
|
| ExclusionCriteria |
| Details |
1. Clinically advised not to perform exercises
2. Prior exposure to Yoga; involved in current or recent (last two months) practice of yoga or those with regular (three times per week or more) participation in other planned exercises, such as aerobics or strength training
3. Known accelerated hypertension
4. Overt clinical congestive heart failure requiring treatment with a diuretic or angiotensin converting enzyme inhibitor.
5. Renal failure (serum creatinine of more than 150 µmol/l)
6. Condition expected to severely limit survival, e.g. terminal illness
7. Clinical diagnosis of dementia
8. Resident in a nursing home, i.e. where the dependency and care requirements of the patients are such that they require the regular input of qualified nurses and therefore the majority of staff in the home are nurses (other forms of residential care are acceptable).
9. Unable to stand up or walk
10. Participation in a drug trial within the past month preceding selection.
11. Alcohol or drug abuse
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
KDM-based BA estimates
Albumin, blood urea nitrogen, creatinine, C-reactive protein, cytomegalovirus
optical density, glycated hemoglobin, total cholesterol, white blood cell count, lymphocyte percent, mean corpuscular volume, and systolic blood pressure |
3 time points
Baseline
6th month
12th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
IL-6,TNF alpha-receptor II, CRP, GDF15, insulin, IGF1, cystatin C, NT-proBNP, hemoglobin A1c.
Walk-speed test, grip-strength, forced expiratory volume test, Balance, Quality of life, Loneliness scale and cognition |
3 time points
Baseline
6th month
12th month |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
01/08/2022 |
| 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) |
Closed to Recruitment of Participants |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A wide spectrum of health benefits have been reported to be associated with yoga, that include improved cognition, respiration, reduced cardiovascular risk, body mass index, blood pressure, glycemic control (diabetes) and other levels of endocrine control. In elderly populations, Yoga-based interventions have been physiological effects in elderly. However, most of these interventions have targeted the mobility, flexibility, cognition, gait, fraility, self-rated health and well-being as the outcomes. The cumulative benefits indicate towards an ability of yoga in aiding physiological integrity. Hence we aim to test the effect of yoga on indicators of physiological multisystem decline well captured by the KDM-based BA estimates |