| CTRI Number |
CTRI/2024/03/064749 [Registered on: 26/03/2024] Trial Registered Prospectively |
| Last Modified On: |
22/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Buteyko Breathing Technique on Blood Pressure in Primary Hypertensive Patients |
|
Scientific Title of Study
|
Effect of Buteyko Breathing Technique on Blood Pressure in Subjects with Primary Hypertension |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
BOOSHAA S R |
| Designation |
MPT CARDIO-RESPIRATORY STUDENT |
| Affiliation |
Sri Ramakrishna Institute Of Paramedical Sciences |
| Address |
Sri Ramakrishna Institute Of Paramedical Sciences
Physiotherapy Department; Division of general medicine; Room no:3
395 Sarojini Naidu road sidhapuddur
coimbatore
Coimbatore
TAMIL NADU
641044
India |
| Phone |
6381775653 |
| Fax |
|
| Email |
booshaarajan23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
AMUTHA R |
| Designation |
Professor |
| Affiliation |
Sri Ramakrishna Institute Of Paramedical Sciences |
| Address |
Sri Ramakrishna Institute Of Paramedical Sciences
Physiotherapy Department; Division of general medicine; Room no:3
395 Sarojini Naidu road sidhapuddur
coimbatore
Coimbatore
TAMIL NADU
641044
India |
| Phone |
9843255234 |
| Fax |
|
| Email |
ramuthakk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
BOOSHAA S R |
| Designation |
MPT CARDIO-RESPIRATORY STUDENT |
| Affiliation |
Sri Ramakrishna Institute Of Paramedical Sciences |
| Address |
Sri Ramakrishna Institute Of Paramedical Sciences
Physiotherapy Department; Division of general medicine; Room no:3
395 Sarojini Naidu road sidhapuddur
coimbatore
Coimbatore
TAMIL NADU
641044
India |
| Phone |
6381775653 |
| Fax |
|
| Email |
booshaarajan23@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ramakrishna Institute of Paramedical Sciences, Division of General Medicine,395 Sarojini Naidu Road, Sidhapudur, Coimbatore |
|
|
Primary Sponsor
|
| Name |
BOOSHAA S R |
| Address |
Sri Ramakrishna Institute Of Paramedical Sciences
Physiotherapy Department; Division of general medicine; Room no:3
395 Sarojini Naidu road sidhapuddur
coimbatore |
| 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 Jambulingam P |
Sri Ramakrishna Multispeciality Hospital |
Sri Ramakrishna Institute Of Paramedical Sciences
Physiotherapy Department; Division of general medicine; Room no:3
395 Sarojini Naidu road sidhapuddur
coimbatore
Coimbatore
TAMIL NADU |
6381775653
booshaarajan23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI RAMAKRISHNA HOSPITAL ETHICAL COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Buteyko breathing technique
Medication
30 minutes walking
Diet chart |
7 days in a week of 6 consecutive weeks for the duration of 30 to 40minutes twice a day |
| Intervention |
Medication
30 minutes walking
Diet chart |
7 days in a week of 6 consecutive weeks for the duration of 30 to 40minutes twice a day |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Systolic Pressure 140 TO 159 mmHg
Diastolic Pressure 90 to 99mmHg
Patient With Clinically Diagnosed Hypertension for More Than 1 Year
Alcoholic
BMI 18.5 TO 24.9 |
|
| ExclusionCriteria |
| Details |
Unable to understand the technique
Deep vein thrombosis
Patients with any psychological or neurological problems
Patients with diabetes mellitus
Auto immune disease
Any Lung Pathology
Patients with any cardiac ad respiratory problems
kyphosis or scoliosis |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Sphygmomanometer
breath hold time |
At baseline and 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/04/2024 |
| 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)
|
Open to Recruitment |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [booshaarajan23@gmail.com].
- For how long will this data be available start date provided 25-03-2024 and end date provided 31-10-2024?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
EFFECT OF BUTEYKO BREATHING TECHNIQUE ON BLOOD PRESSURE IN SUBJECTS WITH PRIMARY HYPERTENSION
ABSTRACT BACKGROUND: Hypertension is the medical term for elevated blood pressure, that persists over time and it affects more than billion people all over the world. hypertension and its complications are responsible for 9.4 million deaths worldwide per year. the prevalence of hypertension in India has been reported as 29.8%. as stated by Rosalba Courtney (2008) the Buteyko breathing method is unique therapy that uses breath control and breath controlling exercises to treat wide range of health condition. this technique was developed by Dr. Konstantin Palvorich Buteyko, aimed to retrain the breathing pattern to correct the oxygen and Carbon dioxide levels in blood stream.
OBJECTIVE: To find out the effect of Buteyko breathing technique on systolic and diastolic blood pressure and heart rate in subjects with primary hypertension. METHODS: It is the interventional study with total of 30 subjects both male and female will be selected based on inclusion and exclusion criteria. they will be divided in to 2 groups A B(15 subjects in each group) treated for 7 days in a week of 6 consecutive weeks(twice a day). sphygmomanometer and breath hold time is used to assess pre and post effect of intervention.
RESULTS: Statistical analysis will be done after data collection and conclusion would be drawn. |