| CTRI Number |
CTRI/2023/01/048936 [Registered on: 12/01/2023] Trial Registered Prospectively |
| Last Modified On: |
09/08/2024 |
| 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 device guided breathing on psycho-physiological variables in patients with obesity |
|
Scientific Title of Study
|
Do the different characteristics of yoga breathings effect on hunger pangs, satiety, motivation for physical activity and exercise or working |
| 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 |
Patanjali Yogpeeth Phase-I, Haridwar
Patanjali Yogpeeth Phase-I, Haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9897963254 |
| Fax |
|
| 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 |
Patanjali Yogpeeth Phase-I, Haridwar
Patanjali Yogpeeth Phase-I, Haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9897963254 |
| Fax |
|
| 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 |
Patanjali Yogpeeth Phase-I, Haridwar
Patanjali Yogpeeth Phase-I, Haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9897963254 |
| Fax |
|
| Email |
office@prft.co.in |
|
|
Source of Monetary or Material Support
|
| Patanjali Research Foundation Trust, Patanjali Yogpeeth Phase-I, Haridwar-249405, Uttarakhand, India |
|
|
Primary Sponsor
|
| Name |
Patanjali Research Foundation Trust |
| Address |
Patanjali Yogpeeth Phase-I, Haridwar-249405, Uttarakhand, India. |
| 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/Wellness center |
Autonomic Lab, Department of yoga Research, 2nd Floor Sadbhawana Building, Patanjali
Yogpeeth Phase-I, Bahadrabad, Haridwar
Hardwar
UTTARANCHAL |
9897963254
office@prft.co.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 |
| Patients |
(1) ICD-10 Condition: E669||Obesity, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Device guided breathing |
Intervention arms: There will be the following interventional sessions
(i) slow breathing at 6 breaths per minute equal duration of inhale and exhale
(ii)deep breathing at 12 breaths per minute equal duration of inhale and exhale
(iii)breathing at 12 breaths per minute small duration of inhale followed by prolonged duration of exhale
The total duration for above mentioned intervention sessions will be of 10 minutes with 2 epochs of 5 minutes each with 1 minute rest between the two intervention session.
Participants will be asked to inhale when the circle starts filling in blue color while the exhale when the color starts disappear from the circle.
Time points (i) Pre 5 minutes ; (ii) During 10 minutes (2 epochs of 5 minutes each with 1 minute rest) and (iii) Post 5 minutes |
| Comparator Agent |
Gazing (QR) no conscious change in breath |
Patients will be ask to gaze at the fixed screen for a similar duration i.e. total duration of 10 minutes with 2 sessions of 5 minutes each with 1 minute rest between the two control session |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients will be recruited based on following inclusion criteria
(i) Patients will be screened for obesity as per ICMR guideline for diagnosis of obesity and case-history obtained by a physician
(ii)Semi structured interview |
|
| ExclusionCriteria |
| Details |
Patients will be excluded based on following exclusion criteria
(i) Patients with an extra systole based on EKG recordings
(ii) Patients with uncontrolled health conditions such as cardiovascular, respiratory and malignancy. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Psychological variables
(i) Hunger and Satiety level through visual analogue Scales
(ii) Present state of food craving using Food Cravings Questionnaire–State (FCQ–S).
(iii) Mood using Brief Mood Introspection Scale (BMIS)
(iv) Impulsivity using The STIMP (STate IMPulsivity) scale |
Psychological variables will be assessed at two time points
(i) Before the intervention/control session
(ii) After the intervention/control session |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Physiological outcomes
(i) Heart rate variability (HRV)
(ii) Respiration rate (RR) |
(i) Before the intervention (Pre): duration 5 minutes
(ii) During the intervention (During): Total duration of 10 minutes having two epochs of 5 minutes each with 1 minute rest between the two epochs
(iii) After the intervention (Post): duration 5 minutes |
| other psychological outcomes |
After the intervention
(i) Quality of intervention using visual analog scale
(ii) Subjective feeling of anxiety, calmness, discomfort and relaxation through visual analog |
|
|
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)
|
15/01/2023 |
| 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="0"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The objective of the present study is to assess the effect of device guided breathing on hunger, satiety, motivation and autonomic function in patients with obesity. In the present study both male and female patients having age range between 20 to 60 years will be recruited from an Ayurveda and yoga therapy center located in north of India. |