| CTRI Number |
CTRI/2025/01/079525 [Registered on: 27/01/2025] Trial Registered Prospectively |
| Last Modified On: |
27/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Yoga-Based Lifestyle on holistic development of adolescents |
|
Scientific Title of Study
|
Effect of Yoga-Based Lifestyle Intervention on Autonomic and Cognitive functions, Social Connectedness, Psychological and Spiritual Well-Being in
Adolescents: A waitlist 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 |
Gyanprakash Kumar |
| Designation |
P.h.D Scholar |
| Affiliation |
S-VYASA Deemed to be University |
| Address |
S-VYASA University
Department of Yoga and Physical Sciences, Room No. 2
Jigani, Anekal, Bengaluru, 560105
Bangalore
KARNATAKA
560105
India |
| Phone |
7349578482 |
| Fax |
|
| Email |
kumarjayjeet@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Rajesh Nair |
| Designation |
Assistant Professor |
| Affiliation |
S-VYASA Deemed to be University |
| Address |
S-VYASA Deemed to be University
Vivekananda Road, Kalluballu Post, Jigani, Anekal, Bengaluru, 560105, INDIA
Bangalore
KARNATAKA
560105
India |
| Phone |
|
| Fax |
|
| Email |
rajeshnair@svyasa.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Prof. Narayan Behera |
| Designation |
Dean of Department of Yoga & Physical Sciences |
| Affiliation |
S-VYASA Deemed to be University |
| Address |
S-VYASA Deemed to be University
Department of Yoga & Physical Sciences, Room no. 2
Vivekananda Road, Kalluballu Post, Jigani, Anekal, Bengaluru, 560105, INDIA
Bangalore
KARNATAKA
560105
India |
| Phone |
|
| Fax |
|
| Email |
narayanbehera@svyasa.edu.in |
|
|
Source of Monetary or Material Support
|
| S-VYASA Deemed to be University
Prashanti Kutiram, Vivekananda Road, Kalluballu Post, Jigani, Anekal, Bengaluru, 560105, INDIA |
|
|
Primary Sponsor
|
| Name |
Gyanprakash Kumar |
| Address |
S-VYASA Deemed to be University
Prashanti Kutiram, Vivekananda Road, Kalluballu Post, Jigani, Anekal, Bengaluru, 560105, INDIA |
| Type of Sponsor |
Other [Individual] |
|
|
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 |
| Ranjay singh |
Ramkunj Public school |
khedalpura bihta patna bihar 801103
Patna
BIHAR |
9934268281
ranjaysingh1010@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee(IEC)-SVYASA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
physiological, psychological, social, and spiritual health. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group |
Regular activities like exercises, games, etc. for 3 months. |
| Intervention |
Yoga-based lifestyle modifications |
Intervention details:
Asana (Yoga Postures),
Pranayama (Yogic Breathing),
Meditation,
Yogic Games.
Duration and frequency:
90-min. sessions, 5 days/week, for 3 months. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Healthy population between the age of 12 to 16 years.
Willing to participate in and follow study conditions.
Able to follow yoga module
Participants with no or minimal prior experience of yoga
|
|
| ExclusionCriteria |
| Details |
Any kind of physical or mental illness or being on medication, based on a routine case history and medical examination.
Smoking, alcohol, or any substance abuse
Subject who cannot perform the assessment task.
Any condition where physical activity was contraindicated.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Heart Rate Variability (HRV)
|
pre-intervention (zero month) and post-intervention (third month) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Prefrontal-EEG activity |
pre-intervention (zero month) and post-intervention (third month) |
| Cognitive function |
pre-intervention (zero month) and post-intervention (third month) |
| Self esteem |
pre-intervention (zero month), post-intervention (third month) and Follow-up (sixth month) |
| Stress, anxiety and depression level |
pre-intervention (zero month), post-intervention (third month) and Follow-up (sixth month) |
| Social Connectedness |
pre-intervention (zero month), post-intervention (third month) and Follow-up (sixth month) |
| Spiritual Well-Being. |
pre-intervention (zero month), post-intervention (third month) and Follow-up (sixth month) |
| Body Mass Index (BMI) |
pre-intervention (zero month) and post-intervention (third month) |
| Sleep quality |
pre-intervention (zero month) and post-intervention (third month) |
| Academic Performance |
pre-intervention (zero month) and post-intervention (third month) |
| Overall Well-Being |
pre-intervention (zero month), post-intervention (third month) and Follow-up (sixth month) |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
10/02/2025 |
| 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="0"
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
|
Many studies
have shown that adolescents face various problems like anxiety, depression,
body shaming, obesity, and bullying, which affect their overall well-being.
Yoga, with its holistic approach, is considered a good practice to address
these issues. However, most research so far has focused only on specific parts of
yoga, like asanas, pranayama, and meditation, while ancient yogic texts mention
many other practices and lifestyle principles.
This study aims to fill this gap
by developing a complete yoga-based lifestyle module based on ancient wisdom
and supported by scientific research. The module combines various yoga
practices with lifestyle changes to help manage these challenges in adolescents.
This study will be assessing how effective this specific module is in improving
their autonomic and cognitive functions, social connections, mental health, and
spiritual well-being, offering a balanced approach to their overall growth and
development. |