| CTRI Number |
CTRI/2020/11/029212 [Registered on: 18/11/2020] Trial Registered Prospectively |
| Last Modified On: |
17/11/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy
Preventive
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To determine how the treatment with physical activity and yoga program for 12 weeks will bring change in leptin (a satiety hormone secreted by adipose tissue) resistance in people with metabolic syndrome |
|
Scientific Title of Study
|
Effectiveness of yoga and lifestyle modification on leptin resistance and quality of life among people with metabolic syndrome |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr G Arun Maiya |
| Designation |
Professor and Dean |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Centre for Diabetic foot care and Research, Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845350823 |
| Fax |
|
| Email |
ajmaiya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G Arun Maiya |
| Designation |
Professor and Dean |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Centre for Diabetic foot care and Research, Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845350823 |
| Fax |
|
| Email |
ajmaiya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr G Arun Maiya |
| Designation |
Professor and Dean |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Centre for Diabetic foot care and Research, Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9845350823 |
| Fax |
|
| Email |
ajmaiya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Science and Technology, KIRAN division, Science and technology in yoga and meditation(SATYAM) |
|
|
Primary Sponsor
|
| Name |
Department of Science and technology Science and technology in yoga and meditation DSTSATYAM |
| Address |
Department of Science and Technology Technology Bhavan
New Mehrauli Road New Delhi 110016 Telephone:911126562122 |
| Type of Sponsor |
Government funding agency |
|
|
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 G Arun Maiya |
centre for diabetic foot care and research Kasturba Hospital |
Room no 2, center for diabetic foot care and research, department of physiotherapy, Kasturba hospital Madhav nagar manipal
Udupi
KARNATAKA |
9845350823
ajmaiya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E660||Obesity due to excess calories, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
physical activity promotion |
The participants in this group will under go 12 weeks of physical activity promotion program which is home based |
| Comparator Agent |
Standard physician advised care |
The participants in this group will follow physician advised care which includes diet and medical prescription |
| Intervention |
Yoga Program |
The participants in this group will be give yoga program for 12 weeks in which 2 weeks of supervised yoga sessions will be give followed by 10 weeks of home based yoga program |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Participants with age group above
30 years to 50 years, either gender are included in the study. Participants will be included on the basis of metabolic syndrome parameters like waist circumference >94cm for males and >80cmfor females, BMI>25kg/m2, fasting blood glucose >100mg/dl, blood pressure >130/85mmhg,
serum triglycerides >150mg/dl, HDL <40mg/dl for males and <50 mg/dl serum leptin levels >
9.5ng/ml for males >25.0ng/ml for females, sedentary lifestyle according to GPAQ screening |
|
| ExclusionCriteria |
| Details |
History of smoking past 6 months, Cardiovascular disease, Stroke, TIA, Any cognitive impairment, Any recent surgeries which hinder with physical activity, Systemic illness |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
leptin resistance
quality of life |
Baseline
12 weeks
6months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Body composition, BMR, Homocysteine, Fasting Insulin Level |
Baseline
12 weeks
6months |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
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)
|
26/11/2020 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Due to modernization and mechanization and physical inactivity and life style change, there is increase in prevalence of metabolic syndrome among Indian population which is a strong predictor for cardiovascular diseases. The early prevention strategies like Yoga and lifestyle modification like physical activity promotion is beneficial in preventing metabolic syndrome. Due to modernization and mechanization, physical inactivity has become a strong predictor for the above conditions. Therefore there is a need to promote lifestyle modification programs like yoga, physical activity and exercise. There is a need for establishing the evidence of these lifestyle modification programs clinically, biochemically and on quality of life. So the present study focuses on the yoga and lifestyle modification program on leptin resistance and quality of life in metabolic syndrome
|