| CTRI Number |
CTRI/2026/03/106505 [Registered on: 18/03/2026] Trial Registered Prospectively |
| Last Modified On: |
25/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Short-Term Effects of Slow Breathing Exercises on Blood Pressure in People with High Blood Pressure. |
|
Scientific Title of Study
|
short term effect of the resonance breathing technique on blood pressure in mild to moderate hypertensive patients: A randomised 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 |
Praneeta More |
| Designation |
Post graduate student |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Upper Basement , Department of Physiotherapy, Manipal Hospital, No 98, Rustam Bagh, Old Airport Road, Bangalore
Bangalore
KARNATAKA
560017
India
Bangalore
KARNATAKA
560017
India |
| Phone |
9075279069 |
| Fax |
|
| Email |
praneeta.mhsblr2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Prem |
| Designation |
Additional Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, Manipal Hospital #98, HAL,Old Airport Road, Rustam Bagh, Old Airport Road, Bangalore
Bangalore
KARNATAKA
560017
India
Bangalore
KARNATAKA
560017
India |
| Phone |
9886647732 |
| Fax |
|
| Email |
prem.v@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr V Prem |
| Designation |
Additional Professor |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, Manipal Hospital #98, HAL,Old Airport Road, Rustam Bagh, Old Airport Road, Bangalore
Bangalore
KARNATAKA
560017
India
Bangalore
KARNATAKA
560017
India |
| Phone |
9886647732 |
| Fax |
|
| Email |
prem.v@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal Hospital #98, HAL,Old Airport Road, Bangalore, KARNATAKA 560017 |
|
|
Primary Sponsor
|
| Name |
Manipal Academy of Higher Education |
| Address |
Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal Hospital , 98, HAL,Old Airport Road, Bangalore, KARNATAKA 560017 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Praneeta More |
Manipal Hospitals |
Upper Basement, Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal Hospital #98, HAL,Old Airport Road, Bangalore, KARNATAKA 560017
Bangalore
KARNATAKA |
9075279069
praneeta.mhsblr2024@learner.manipal.edu |
|
|
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: I10||Essential (primary) hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Pursed Lip Breathing Technique. |
Participants have to take deep breath through nose and exhale through mouth while making pursed lips. |
| Intervention |
Resonance Breathing Technique |
Slow Breathing at 5 breaths per min, so that Participants have to take breath through nose for 5 seconds and and exhale through nose for 5 seconds. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with mild to moderate hypertension by cardiologist and taking antihypertensive medications. |
|
| ExclusionCriteria |
| Details |
Secondary hypertension, Patients diagnosed with sever hypertension (SBP greater than or equal to 180 mmHg and/or DBP greater than or equal to 110 mmHg), Individuals who practicing breathing retraining program for last 6 months), Individuals with respiratory disease, cardiac, renal or cerebrovascular disease, pregnant women. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| systolic and diastolic blood pressure |
baseline and post 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The Scale of Positive and Negative Experience (SPANE) questionnaire, A single-item Sleep Quality Scale (SQS), HR Variability Score (according to Welltory app) SDNN (Standard Deviation of Normal-to-Normal intervals), RMSSD (Root Mean Square of Successive Differences), pNN50 (percentage of successive normal sinus), AMo50 (Mode Amplitude) |
baseline and post 4 weeks |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
30/03/2026 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Hypertension is a common cardiovascular condition that increases the risk of serious health complications. Non-pharmacological interventions such as breathing techniques are increasingly used to help control blood pressure. Resonance breathing may improve autonomic regulation and reduce blood pressure. Therefore, this study aims to evaluate the short-term effect of the resonance breathing technique on blood pressure in patients with mild to moderate hypertension using a randomized controlled trial design. |