| CTRI Number |
CTRI/2024/06/069207 [Registered on: 19/06/2024] Trial Registered Prospectively |
| Last Modified On: |
05/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effect of kaphalbhanti, bhastrika and walking on treadmill on psychophysiology at different rates. |
|
Scientific Title of Study
|
Psychophysiological changes following high frequency yoga breathing (HFYB) at different rates. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Saurav Nilesh |
| Designation |
PhD Scholar |
| Affiliation |
Swami Vivekananda Yoga Anushandhan Samsthana |
| Address |
Depratment of Yoga and Life Sciences, Swami Vivekanada Yoga Anusandhana Samsthana, Post- Kalluballu, Taluk- Anekal,
Jigani, Banglore-560105, Karnataka
Bangalore Rural
KARNATAKA
560105
India |
| Phone |
7631322487 |
| Fax |
|
| Email |
sauravnilesh96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Saurav Nilesh |
| Designation |
PhD Scholar |
| Affiliation |
Swami Vivekananda Yoga Anushandhan Samsthana |
| Address |
Depratment of Yoga and Life Sciences, Swami Vivekanada Yoga Anusandhana Samsthana, Post- Kalluballu, Taluk- Anekal,Jigani, Banglore-560105, Karnataka
Bangalore Rural
KARNATAKA
560105
India |
| Phone |
7631322487 |
| Fax |
|
| Email |
sauravnilesh96@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Raghavendra Bhatt |
| Designation |
Professor |
| Affiliation |
Swami Vivekanada Yoga Anusandhana Samsthana |
| Address |
Depratment of Yoga and Life Sciences, Swami Vivekanada Yoga Anusandhana Samsthana, Post- Kalluballu, Taluk- Anekal,
Jigani, Banglore-560105, Karnataka
Bangalore Rural
KARNATAKA
560105
India |
| Phone |
8147226351 |
| Fax |
|
| Email |
raghavendra.bhat@svyasa.edu.in |
|
|
Source of Monetary or Material Support
|
| Swami Vivekanada Yoga Anusandhana Samsthana, Bengaluru |
|
|
Primary Sponsor
|
| Name |
Saurav Nilesh |
| Address |
Depratment of Yoga and Life Sciences, Swami Vivekanada Yoga Anusandhana Samsthana, Post- Kalluballu, Taluk- Anekal,Jigani, Banglore-560105, Karnataka |
| 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 |
| DR RAGHVENDRA BHATT |
Swami Vivekananda Yoga Anusandhan Samsthana |
Department of Yoga and Life Sciences, Post- Kalluballu, Taluk- Anekal, Jigani-560105
Bangalore Rural
KARNATAKA |
8825344741
raghavendra.bhat@svyasa.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
will exclude participants with health issue |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
High frequency yoga breathing (kapalbhati, bhastrika) |
1 minute of breathing practice at different rates (0.5 Hz, 1Hz, 2 Hz) following 1 minute of relaxation. repetition three times. |
| Comparator Agent |
walking on treadmill (Bruce protocol) |
Brisk walking at a speed of 1.7 miles/hour for 20 minutes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Male |
| Details |
(i) Normal healthy volunteers with age range from 18 to 30.
(ii) Willingness to participate in the trial.
(iii) Participants having experience of yoga more than 6 months will be recruited in the study
|
|
| ExclusionCriteria |
| Details |
(i) The presence of cognitive or neurological disorders, based on a medical history and routine clinical examination. In addition, the following tests would be used:
a. Evidence of identifiable cognitive impairment: It will be assessed using the Montreal Cognitive Assessment (MOCA). Persons with scores lower than 24 will be excluded from further participation.
(ii) Intake of medication, which is known to influence cognitive or autonomic functions.
(iii) Smoking or alcoholism which may influence cognitive functions, sensory and motor variables.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Autonomic and Respiratory variables
2. Metabolic functions
3. Cognitive function
|
pre, during, post |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| psychological tests. (Mindfulness, Mind wondering, perceived stress scale) |
pre, post |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/07/2024 |
| 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
|
i.
High frequency yoga breathing may influence autonomic nervous
system activity, metabolic functions and cognitive functions.
ii.
Performing High frequency yoga breathing at different rates
may influence psychophysiology, autonomic nervous system activity and metabolic
activity differently. |