| CTRI Number |
CTRI/2024/09/073905 [Registered on: 13/09/2024] Trial Registered Prospectively |
| Last Modified On: |
07/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Effects of slow and high frequency yoga breathing on reaction time on undergraduate students of a yoga university. |
|
Scientific Title of Study
|
Effects of pranayamas on reaction time and finger tapping tasks in university students. |
| 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 Shirley Telles |
| Designation |
Research Advisor |
| Affiliation |
Patanjali Research Foundation (Trust) |
| Address |
Department of Yoga Research, 2nd floor, Sadbhawana Building, Patanjali Research Foundation (Trust), Patanjali Yogpeeth Phase 1, Bahadrabad, Hardwar UTTARANCHAL
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9897963254 |
| Fax |
|
| Email |
shirleytelles@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shirley Telles |
| Designation |
Research Advisor |
| Affiliation |
Patanjali Research Foundation (Trust) |
| Address |
Department of Yoga Research, 2nd floor, Sadbhawana Building, Patanjali Research Foundation (Trust), Patanjali Yogpeeth Phase 1, Bahadrabad, Hardwar UTTARANCHAL
UTTARANCHAL
249405
India |
| Phone |
9897963254 |
| Fax |
|
| Email |
shirleytelles@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shirley Telles |
| Designation |
Research Advisor |
| Affiliation |
Patanjali Research Foundation (Trust) |
| Address |
Department of Yoga Research, 2nd floor, Sadbhawana Building, Patanjali Research Foundation (Trust), Patanjali Yogpeeth Phase 1, Bahadrabad, Hardwar UTTARANCHAL
UTTARANCHAL
249405
India |
| Phone |
9897963254 |
| Fax |
|
| Email |
shirleytelles@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Research Foundation (Trust), Patanjali Yogpeeth Phase 1, Bahadrabad, Haridwar, Uttrakhand, India, 249405 |
|
|
Primary Sponsor
|
| Name |
Patanjali Research Foundation Trust |
| Address |
Department of Yoga Research, 2nd floor, Sadbhawana Building, Patanjali Research Foundation (Trust), Patanjali Yogpeeth Phase 1, Bahadrabad, Hardwar UTTARANCHAL |
| Type of Sponsor |
Research institution |
|
|
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 Shirley Telles |
Patanjali Research Foundation (Trust) |
Clinical Monitoring Lab, Department of Yoga Research, 2nd Floor Sadbhawana Building, Patanjali Yogapeeth Phase 1, Bahadrabad, Hardwar UTTARANCHAL
Hardwar
UTTARANCHAL |
9897963254
shirleytelles@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Department of Yoga Research, Patanjali Research Foundation (Trust) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Experiences in yoga for three months |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Breath awareness |
The control session will be for 17 minutes which includes one minute of rest after every five minute of practice. The study intended to determine the immediate effect of the practice. Therefore the participants will be assessed before and after 17 minutes of the control. Hence the total duration of the control session will be 17 minutes only. |
| Intervention |
Bumblebee (Bhramari) yoga breathing |
The intervention session will be for 17 minutes which includes one minute of rest after every five minute of practice. The study intended to determine the immediate effect of the practice. Therefore the participants will be assessed before and after 17 minutes of the intervention. Hence the total duration of the intervention will be 17 minutes only. |
| Intervention |
High frequency yoga breathing |
The intervention session will be for 17 minutes which includes one minute of rest after every five minute of practice. The study intended to determine the immediate effect of the practice. Therefore the participants will be assessed before and after 17 minutes of the intervention. Hence the total duration of the intervention will be 17 minutes only. |
| Comparator Agent |
Quiet Sitting |
The control session will be for 17 minutes which includes one minute of rest after every five minute of practice. The study intended to determine the immediate effect of the practice. Therefore the participants will be assessed before and after 17 minutes of the control. Hence the total duration of the control session will be 17 minutes only. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
(i)Age range 18 to 45 years
(ii) Right handedness
(iii)Experience in yoga practices for three months
(iv) healthy students
|
|
| ExclusionCriteria |
| Details |
(i) No coffee or tea at least two hours before.
(ii) Persons with epilepsy will be excluded
(iii) Persons with an active ear infection will be excluded.
(iv). Persons with extra systole will be excluded.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
(i)Reaction time
(ii)Heart rate variability (HRV) and Respiration rate (RR)
(iii)Finger tapping
|
(i)Reaction time
(ii)Heart rate variability (HRV) and Respiration rate (RR)
(iii)Finger tapping
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
(i) Four analog scales (Visual analog scale),
(ii) Edinburgh handedness inventory
(iii)Digit letter substitution test, and
(iv)Nijmegen
|
(i) Before and after intervention
(ii) Before intervention
(iii) Before and after intervention
(iv) After intervention |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
20/09/2024 |
| 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="1"
Months="0"
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
|
This study aims to assess the effects of the specific pranayama practices on reaction time and finger-tapping tasks in university students while correlating the changes in the reaction time and tapping tasks with the changes in heart rate variability measures and respiratory characteristics of the pranayama practices. |