| CTRI Number |
CTRI/2024/07/070851 [Registered on: 18/07/2024] Trial Registered Prospectively |
| Last Modified On: |
17/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Effects of pranayama on heart and lung function and responsiveness in Athletes. |
|
Scientific Title of Study
|
Effect of Yogic Breath Regulation on Cardiorespiratory Coherence and Auditory Reaction Time in Collegiate Athletes- A 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 |
Dr Avani Venugopal |
| Designation |
PG Scholar |
| Affiliation |
SDM College of Naturopathy and Yogic Sciences |
| Address |
Department of Yoga
SDM College of Naturopathy and Yogic Sciences Ujire Belthangadi
Dakshina Kannada
574240
Karnataka
India
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
8301915458 |
| Fax |
|
| Email |
avanivenugopal1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Avani Venugopal |
| Designation |
PG Scholar |
| Affiliation |
SDM College of Naturopathy and Yogic Sciences |
| Address |
Department of Yoga
SDM College of Naturopathy and Yogic Sciences Ujire Belthangadi
Dakshina Kannada
574240
Karnataka
India
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
8301915458 |
| Fax |
|
| Email |
avanivenugopal1998@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivaprasad Shetty |
| Designation |
Dean Division Of Yoga |
| Affiliation |
SDM College of Naturopathy and Yogic Sciences |
| Address |
Department of Yoga
SDM College of Naturopathy and Yogic Sciences Ujire Belthangadi
Dakshina Kannada
574240
Karnataka
India
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9731854585 |
| Fax |
|
| Email |
drshivapshetty70@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Dharmasthala Manjunatheshwara Yoga and Nature cure Hospital Shantivana, Dharmashala, Belthangadi, Dakshina Kannada- 574216 Karnataka India |
|
|
Primary Sponsor
|
| Name |
Dr Avani Venugopal |
| Address |
SDM College of Naturopathy and Yogic Sciences, Ujire Belthangadi,
Dakshina Kannada-574240 |
| 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 Avani Venugopal |
Shri Dharmasthala Manjunatheshwara Yoga and Nature Cure Hospital Shantivana |
COE, Department of Clinical Yoga, Shantivana, Dharmasthala, Belthangadi, Dakshina Kannada- 574216 Karnataka India
Dakshina Kannada
KARNATAKA |
8301915458
avanivenugopal1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Normal sports activities |
No specific intervention other than their routine practice. |
| Intervention |
Yogic breathing techniques (Pranayama) |
Bhastrika Pranayama
Suryabhedana pranayama
Modified Nadishuddhi Pranayama
Brahmari Pranayama |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
23.00 Year(s) |
| Gender |
Both |
| Details |
1. Age: 16 – 23 years
2. Gender- male and female
3. New to regular pranayama practice.
4. Ability to understand and follow instruction for pranayama practice
|
|
| ExclusionCriteria |
| Details |
1. Musculoskeletal injuries at the time of testing.
2. Extensive prior experience with yoga.
3. Regular practice in special training courses or traditional Chinese health exercises such as Qigong and Tai chi.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Auditory reaction time, Cardiorespiratory coupling from heart rate variability |
At base line and after 30 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Cardiorespiratory coupling from heart rate variability |
one month after pre assessment |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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 1 |
|
Date of First Enrollment (India)
|
01/08/2024 |
| 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="8"
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
|
To evaluate the impact of yogic breath regulation on cardiorespiratory coupling and Auditory reaction time among collegiate athletes. |