| CTRI Number |
CTRI/2023/06/053690 [Registered on: 08/06/2023] Trial Registered Prospectively |
| Last Modified On: |
06/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Effect of Yoga on Health of Elderly |
|
Scientific Title of Study
|
Effect of Selected Yogic Practices on Health Status of Inhabitants of Old Age Homes |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vinod Patel |
| Designation |
PhD Scholar |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Swasthavritta and Yoga Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi UP
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8305325357 |
| Fax |
|
| Email |
Vinod7497kushvaha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Neeru Nathani |
| Designation |
Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Swasthavritta and Yoga Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi UP
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9935655129 |
| Fax |
|
| Email |
nsneeru@bhu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Vinod Patel |
| Designation |
PhD Scholar |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Swasthavritta and Yoga Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi UP
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8305325357 |
| Fax |
|
| Email |
Vinod7497kushvaha@gmail.com |
|
|
Source of Monetary or Material Support
|
|
Old Age Home Sarnath
Railway station near sarnath Sarnath Varanasi Uttar Pradesh 221007 |
| Dharmasangh Sikshamandal
Durgakund Bhelupur Rd Durgakund Jawahar Nagar Colony Bhelupur Varanasi Uttar Pradesh 221005
|
| Government old and disabled home Women
Durgakund Anandbagh Bhelupur Varanasi Uttar Pradesh 221005 |
| Kashi Mumukshu Bhawan Sabha
Near Mumukshu Bhawan Assi Anandbagh Bhelupur Varanasi Uttar Pradesh 221005 |
|
|
Primary Sponsor
|
| Name |
Department of Swasthavritta and Yoga Faculty of Ayurveda Institute of Medical Science |
| Address |
Department of Swasthavritta and Yoga Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi UP |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dharmasangh Sikshamandal |
Durgakund Bhelupur Rd Durgakund Jawahar Nagar Colony Bhelupur Varanasi Uttar Pradesh 221005 |
| Government old and disabled home Women |
Durgakund Anandbagh Bhelupur Varanasi Uttar Pradesh 221005 |
| Kashi Mumukshu Bhawan Sabha |
Near Mumukshu Bhawan Assi Anandbagh Bhelupur Varanasi Uttar Pradesh 221005 |
| Old Age Home Sarnat |
Railway station near sarnath Sarnath Varanasi Uttar Pradesh 221007 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Vinod Patel |
Banaras Hindu University, Varanasi |
Department of Swasthavritta and Yoga Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi UP
Varanasi
UTTAR PRADESH |
8305325357
Vinod7497kushvaha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Institute of Medical Sciences, Banaras Hindu University, Varanasi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
The apparently healthy old age persons without any physical and mental illness |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No intervention |
The participants of the Control Group will not be advised of any intervention. |
| Intervention |
Selected Yoga Protocol |
The participants of the Study Group will be advised to practice Selected Yoga Protocol for 1 hour daily (minimum for 6 days/week).
The total period of intervention will be for 03 Months, in offline mode. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1 Older people of both gender belonging to age >60 years and upto 80 years
2 Inhabitants of Old Age Homes who are capable of practicing Yoga
3 Inhabitants of Old Age Homes willing to participate & respond, with consent
|
|
| ExclusionCriteria |
| Details |
1 Older people of both gender belonging to the age <60 years and >80 years.
2 Older people who are not willing to participate in the study.
3 Those who are unable to practice Yoga.
4 Who are already involved in any Yoga practices.
5 Older people suffering from total loss of vision or hearing or any acute or chronic disease that limits the ability of individual to participate in the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Dates of Birth or day of the Week |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Level of Anxiety
Level of Depression
Quality of life
Blood Pressure
Body Mass Index |
The outcome Parameters of both groups will be assessed at baseline and at three follow-ups i.e. at the interval of 1 month, 2 months and 3 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
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)
|
20/06/2023 |
| 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 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
|
This study will evaluate the effect of the Selected Yoga Protocol on the Health Status of Inhabitants of old age homes, confined to males and females of age groups >60 years to 80 years. There will be a total of two groups- 1. The participants of the Control group will not be advised of any Intervention. 2. The participants of the Study Group will be advised to practice Selected Yoga Protocol for 1 hour daily (minimum for 6 days/week), for a total period of 3 Months, in offline mode. The registered participants of both groups will be evaluated on the basis of subjective and objective parameters to assess the efficacy of the Selected Yoga Protocol on the Health Status of inhabitants of old Age Homes. The outcome Parameters of both groups will be assessed at baseline and at three follow-ups i.e. at the interval of 1 month, 2 months, and 3 months. |