| CTRI Number |
CTRI/2025/04/084337 [Registered on: 07/04/2025] Trial Registered Prospectively |
| Last Modified On: |
04/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study of Power Yoga on Orphan children |
|
Scientific Title of Study
|
EFFECTIVENESS OF POWER YOGA ON PHYSICAL PHYSIOLOGICAL AND PSYCHOLOGICAL WELLBEING OF ORPHAN CHILDREN |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nill |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pooja Singh |
| Designation |
PhD Scholar |
| Affiliation |
Laxmibai national institute of physical education Gwalior |
| Address |
Department of Yogic Sciences, Lakshmibai National Institute of Physical Education, Racecourse Road, Mela Road, Shakti Nagar, Gwalior, Madhya Pradesh
Racecourse Rd, LNUPE Campus, Shakti Nagar, Gwalior, Madhya Pradesh 474002
Gwalior
MADHYA PRADESH
474002
India |
| Phone |
9752345512 |
| Fax |
0 |
| Email |
poojasingh.lnipe@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashish Phulkar |
| Designation |
Senior Associate Professor |
| Affiliation |
Laxmibai national institute of physical education Gwalior |
| Address |
Department of Yogic Sciences, Lakshmibai National Institute of Physical Education, Racecourse Road, Mela Road, Shakti Nagar, Gwalior, Madhya Pradesh
Gwalior
MADHYA PRADESH
474002
India |
| Phone |
6263773720 |
| Fax |
0 |
| Email |
ashishlnipe@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pooja Singh |
| Designation |
PhD Scholar |
| Affiliation |
Laxmibai national institute of physical education Gwalior |
| Address |
Department of Yogic Sciences, Lakshmibai National Institute of Physical Education, Racecourse Road, Mela Road, Shakti Nagar, Gwalior, Madhya Pradesh
Gwalior
MADHYA PRADESH
474002
India |
| Phone |
9752345512 |
| Fax |
0 |
| Email |
poojasingh.lnipe@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Yogic Sciences, Lakshmibai National Institute of Physical Education, Racecourse Road, Mela Road, Shakti Nagar, Gwalior, Madhya Pradesh, India,
474002
|
|
|
Primary Sponsor
|
| Name |
Dr Ashish Phulkar |
| Address |
Department of Yogic Sciences, Lakshmibai National Institute of Physical Education, Racecourse Road, Mela Road, Shakti Nagar, Gwalior, Madhya Pradesh, 474002
|
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| Pooja Singh |
Government Orphan School Shree Rajkumari Bai Niketan, Ladli Basera seva Bharti, Jagrati Center |
1. 925, Napier Town, Shastri Bridge, Jabalpur, 482001
2. Ghari Chowk, Vijay Nagar, Jabalpur, 482002
3. Indira Market Tagore Railway Colony, South Civil Lines, Jabalpur, Madhya Pradesh 482001
Jabalpur
MADHYA PRADESH |
9752345512
0
poojasingh.lnipe@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Physical, physiological and psychological wellbeing of orphan children |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ACTIVE CONTROL GROUP |
Active Control Group Participants Continue Their Regular Activities |
| Intervention |
POWER YOGA |
1. Prayer (2 minutes)
2. Warm up each practice
(8 minutes)
3. Sun Salutation B
(7 minutes).
4. Asana (15 minutes)
5. Stretching and Relaxation (6 minutes)
6. Ujjayi Pranayama (5 minutes)
7. Shanti Path (2 minutes)
Total Practice Time - 45-50 Minutes
Frequency 3-5 sets each practice |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1. The participants of the study are selected based on their physical, physiological, and psychological well-being.
2. Only selected orphan school children will be included.
3. Subjects of the age group between 13 to 18 years.
4. Physically and mentally fit children will be included.
|
|
| ExclusionCriteria |
| Details |
1. Physical handicapped and Psychiatric disorders patients(children) will be excluded.
2. Chronic disease patients will be excluded.
3. Advanced Yoga practitioners and Yogaasana athletes will be excluded.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Physical Parameters: Aerobic fitness, Flexibility, and Shoulder Strength.
2. Physiological Parameters:
Heart rate, Blood Pressure (Systolic & Diastolic), and Respiratory rate.
3. Psychological parameters: Autonomy, Environmental Mastery, Personal Growth,
Positive relations with others, Purpose in life, & Self-acceptance.
|
12 Weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Holistic development of children |
Day 1 and Day 90 |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
10/05/2025 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
THIS STUDY IS A RANDOMISED PARALLEL GROUP, ACTIVE CONTROL TRIAL FOR ORPHAN CHILDREN. THE PRIMARY AND SECONDARY OUTCOME MEASURE WILL BE COMPLETED IN 12 WEEKS. CHILDREN WILL FOLLOW A UNIQUE POWER YOGA MODULE WHICH HAS BEEN DEVELOPED BY THE PRINCIPAL INVESTIGATOR. DURATION OF POWER YOGA MODULE WILL BE 45 MINUTES. THE STUDY WILL BE DELIMITED TO THE AGE OF SUBJECTS RANGING BETWEEN 13 AND 18 YEARS. THE MAIN OBJECTIVE OF THE STUDY IS TO SEE THE EFFECTIVENESS OF POWER YOGA ON THE PHYSICAL, PHYSIOLOGICAL, AND PSYCHOLOGICAL WELL-BEING OF ORPHAN CHILDREN. TO SEE THE IMPACT OF POWER YOGA PRACTICES ON PHYSICAL, PHYSIOLOGICAL, AND PSYCHOLOGICAL WELL-BEING. THIS STUDY MAY BRING CONSCIOUSNESS/AWARENESS HOLISTIC DEVELOPMENT AMONG CHILDREN. |