| CTRI Number |
CTRI/2021/11/037730 [Registered on: 01/11/2021] Trial Registered Prospectively |
| Last Modified On: |
27/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Effect of yoga breathing on autonomic and respiratory variables |
|
Scientific Title of Study
|
Effect of metronome guided breathing vs volitionally regulated yoga breathing on autonomic and respiratory variables |
| Trial Acronym |
|
|
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 |
Director of Research |
| 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
249405
India |
| Phone |
9897963254 |
| Fax |
9896973254 |
| Email |
office@prft.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shirley Telles |
| Designation |
Director of Research |
| 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
249405
India |
| Phone |
9897963254 |
| Fax |
9896973254 |
| Email |
office@prft.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shirley Telles |
| Designation |
Director of Research |
| 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
249405
India |
| Phone |
9897963254 |
| Fax |
9896973254 |
| Email |
office@prft.co.in |
|
|
Source of Monetary or Material Support
|
| Patanjali Research Foundation Trust |
|
|
Primary Sponsor
|
| Name |
Patanjali Research Foundation Trust |
| Address |
Patanjali Yogpeeth Phase1, Bahadrabad, Haridwar, Uttrakhand, India, 249405 |
| 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) |
Autonomic Lab, Department of Yoga Research, 2nd floor, Sadbhawana Building, Patanjali Research Foundation (Trust), Patanjali Yogpeeth Phase 1, Bahadrabad,
Hardwar
UTTARANCHAL |
9897963254
office@prft.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Department of Yoga Research, Patanjali Reaearch Foundation Trust |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Device guided breathing with inhale equal to exhale |
(i) Pre (5 minutes), (ii) During intervention (18 minutes with three epochs of 5 minutes with one minute rest between two consecutive epochs) and (iii) Post (5 minutes). |
| Intervention |
Device guided breathing with inhale greater than exhale |
(i) Pre (5 minutes), (ii) During intervention (18 minutes with three epochs of 5 minutes with one minute rest between two consecutive epochs) and (iii) Post (5 minutes). |
| Intervention |
Device guided breathing with inhale lower than exhale |
(i) Pre (5 minutes), (ii) During intervention (18 minutes with three epochs of 5 minutes with one minute rest between two consecutive epochs) and (iii) Post (5 minutes). |
| Intervention |
Humming bee breathing (Bhramari pranayama) |
(i) Pre (5 minutes), (ii) During intervention (18 minutes with three epochs of 5 minutes with one minute rest between two consecutive epochs) and (iii) Post (5 minutes). |
| Comparator Agent |
Quiet sitting (Control session) |
(i) Pre (5 minutes), (ii) During (18 minutes with three epochs of 5 minutes with one minute rest between two consecutive epochs) and (iii) Post (5 minutes). |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy adults (health status is based on a semi-structured interview)
2. Minimum yoga experience 3 months |
|
| ExclusionCriteria |
| Details |
1. Person with extra systole based on electrocardiogram (ECG)
2. Tinnitus and an active ear infection are the conditions which are unsafe to practice Bhramari Pranayama |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
(i) Heart rate variability
(ii) Respiration Rate
(iii) Galvanic Skin Response
(iv) Photoplethysmography
(v) Cardiac Output
(vi) Blood Pressure
|
In each session there will be (i) Baseline (5 minutes), (ii) During (18 minutes with three epochs of 5 minutes with one minute rest between two consecutive epochs) and (iii) Post (5 minutes).
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
(i) State-Trait Anxiety Inventory (STAI-s),
(ii) The brief mood introspection scale (BMIS),
(iii) Nijmegen questionnaire (NQ)
(iV) Quality of intervention using Visual analogue scale (VAS). |
1. For STAI-s and BMIS, in each session there will be:(i) Baseline and (ii) Post assessment (after 18 minutes of intervention).
2. For NQ and VAS, in each session there will be: (i) Only post assessment (after 18 minutes of intervention). |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/11/2021 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
The result will be reported in internationally recognized databases (example: PubMed or Scopus or Web of Science) |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The aim of this study is to assess the effects of (i) Bhramari pranayama, (ii) device guided breathing with inhale lower than exhale (iii) device guided breathing with inhale greater than exhale , (iv) device guided breathing with inhale equal to exhale and (iv) quiet rest on (i)Heart rate variability (HRV) and Respiration rate (RR), (ii) Galvanic skin resistance (GSR), (iii) Photo-plethysmography (PPG), (iv)Blood pressure (BP), (v) Cardiac output using MP150 16 channel polygraph system. (i) Spielberger’s state trait anxiety inventory- state (STAI-s), (ii) The brief mood introspection scale (BMIS) will be assessed before and after the intervention and (i) Nijmegen questionnaire (NQ) and (ii) Visual analogue scale (VAS) will be used to assess interventional quality. |