| CTRI Number |
CTRI/2025/05/087824 [Registered on: 28/05/2025] Trial Registered Prospectively |
| Last Modified On: |
28/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Comparing alternate nostril breathing exercise and the diaphragmatic breathing exercise on heart rate and blood pressure on patients with high blood pressure. |
|
Scientific Title of Study
|
Effect of Alternate Nostril Breathing Exercise Versus Diaphragmatic Breathing Exercise on Blood Pressure, Heart Rate and Rate Pressure Product Among Patients with Hypertension: Randomized Clinical 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 |
Janhavi Shende |
| Designation |
Postgraduate Student |
| Affiliation |
Datta Meghe College of Physiotherapy,Nagpur |
| Address |
Datta Meghe College of Physiotherapy, Wanadongri, Hingna Road, Nagpur 441110
Department of Cardiovascular and Respiratory Physiotherapy, Datta Meghe College of Physiotherapy, Wanadongri, Hingna Road, Nagpur 441110
Nagpur
MAHARASHTRA
441110
India |
| Phone |
7057107461 |
| Fax |
|
| Email |
shendejanhavi2018@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shweta Panchbudhe |
| Designation |
Associate Professor |
| Affiliation |
Department of Cardiovascular and Datta Meghe College of Physiotherapy, Nagpur |
| Address |
Department of Cardiovascular and Respiratory Physiotherapy, Datta Meghe College of Physiotherapy, Wanadongri, Hingna Road, Nagpur 441110
Department of Cardiovascular and Respiratory Physiotherapy, Datta Meghe College of Physiotherapy, Wanadongri, Hingna Road, Nagpur 441110
Nagpur
MAHARASHTRA
441110
India |
| Phone |
9049169589 |
| Fax |
|
| Email |
shweta12panchabudhe@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shweta Panchbudhe |
| Designation |
Associate Professor |
| Affiliation |
Department of Cardiovascular and Datta Meghe College of Physiotherapy, Nagpur |
| Address |
Department of Cardiovascular and Respiratory Physiotherapy, Datta Meghe College of Physiotherapy, Wanadongri, Hingna Road, Nagpur 441110
Department of Cardiovascular and Respiratory Physiotherapy, Datta Meghe College of Physiotherapy, Wanadongri, Hingna Road, Nagpur 441110
Nagpur
MAHARASHTRA
441110
India |
| Phone |
9049169589 |
| Fax |
|
| Email |
shweta12panchabudhe@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe College of Physiotherapy, Wanadongri, Hingna Road, Nagpur 441110 Maharashtra , India |
|
|
Primary Sponsor
|
| Name |
Datta Meghe College of Physiotherapy, Nagpur |
| Address |
Shri Datta Meghe Polytechnic campus, Wanadongri, Hingna Road, Nagpur 441110 |
| 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 |
| Janhavi Sende |
Datta Meghe college of physiotherapy OPD |
Shri Datta Meghe Polytechnic campus, Wanadongri, Hingna Road, Nagpur 441110
Nagpur
MAHARASHTRA |
7057107461
shendejanhavi2018@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Nagar Yuvak Sanstha, Datta Meghe College of Physiotherapy,Nagpur |
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 |
Alternate Nostril Breathing Exercise |
Patient position - High sitting
Frequency- once a day
Intensity -10 repetitions
|
| Intervention |
Diaphragmatic Breathing Exercise |
Patient position: Semi Fowler’s position
Frequency -once a day
Intensity - 10 repetitions |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients taking antihypertensive medication
Patients with stage1 and stage 2 hypertension
Patients diagnosed with hypertension more than 5 years
Patients willing to participate
|
|
| ExclusionCriteria |
| Details |
Patients with previous experience of yoga
Patients who were chronic smokers
Patients with co-morbidities like diabetes mellitus, thyroid
History of cardiovascular diseases, arrhythmias or respiratory disorders
Patients with neurological or psychological disorders affecting participation
Patients with renal diseases
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Blood Pressure |
Pre treatment day 1 and post treatment day 10 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Heart rate
Rate pressure product |
Pre treatment day 1 and post treatment day 10 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
16/06/2025 |
| 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
|
Hypertension is a significant risk factor for cardiovascular diseases, necessitating effective, non-pharmacological interventions. The need for this study arises from the growing interest in alternative therapies like controlled breathing exercises, which are simple, cost-effective, and non-invasive approaches to managing blood pressure (BP) and heart rate (HR).
The background of this research highlights the physiological benefits of breathing techniques in autonomic regulation, stress reduction, and cardiovascular health. However, limited comparative studies exist on the efficacy of alternate nostril breathing (ANB) and diaphragmatic breathing (DB) in hypertensive individuals.
This study introduces a novel approach by directly comparing ANB and DB to assess their effects on BP, HR, and rate pressure product (RPP), which reflects myocardial workload. The objective is to determine which technique yields greater cardiovascular benefits, providing evidence-based recommendations for hypertensive management.
A randomized clinical trial was conducted on hypertensive patients aged 30-60 years, divided into two groups. Group A practiced ANB, while Group B performed DB, both for ten days. Pre- and post-intervention measurements of BP, HR, and RPP were analyzed to evaluate the effectiveness of each technique.
The expected outcome includes a significant reduction in BP and HR, supporting the efficacy of structured breathing exercises in hypertension management. This study contributes to the scientific understanding of breathing interventions, potentially influencing clinical guidelines and offering a complementary strategy for individuals seeking holistic approaches to cardiovascular health. Hypertension is a significant risk factor for cardiovascular diseases, necessitating effective, non-pharmacological interventions. The need for this study arises from the growing interest in alternative therapies like controlled breathing exercises, which are simple, cost-effective, and non-invasive approaches to managing blood pressure (BP) and heart rate (HR).
The background of this research highlights the physiological benefits of breathing techniques in autonomic regulation, stress reduction, and cardiovascular health. However, limited comparative studies exist on the efficacy of alternate nostril breathing (ANB) and diaphragmatic breathing (DB) in hypertensive individuals.
This study introduces a novel approach by directly comparing ANB and DB to assess their effects on BP, HR, and rate pressure product (RPP), which reflects myocardial workload. The objective is to determine which technique yields greater cardiovascular benefits, providing evidence-based recommendations for hypertensive management.
A randomized clinical trial was conducted on hypertensive patients aged 30-60 years, divided into two groups. Group A practiced ANB, while Group B performed DB, both for ten days. Pre- and post-intervention measurements of BP, HR, and RPP were analyzed to evaluate the effectiveness of each technique.
The expected outcome includes a significant reduction in BP and HR, supporting the efficacy of structured breathing exercises in hypertension management. This study contributes to the scientific understanding of breathing interventions, potentially influencing clinical guidelines and offering a complementary strategy for individuals seeking holistic approaches to cardiovascular health.
|