| CTRI Number |
CTRI/2026/03/105473 [Registered on: 06/03/2026] Trial Registered Prospectively |
| Last Modified On: |
05/03/2026 |
| 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
|
Can slow deep breathing exercises help reduce blood pressure in people with diabetes and hypertension? |
|
Scientific Title of Study
|
Effect of slow deep breathing on blood pressure in hypertensive diabetic mellitus patients |
| Trial Acronym |
SDB-BP DM trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrJayaraman G |
| Designation |
Assistant Professor |
| Affiliation |
Physiotherapy Deaprtment |
| Address |
Physiotherapy Department Punjabi
University Patiala
Punjab
147002
India
Patiala
PUNJAB
147002
India |
| Phone |
9914889469 |
| Fax |
|
| Email |
jayaraman_mpt@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrJayaraman G |
| Designation |
Assistant Professor |
| Affiliation |
Physiotherapy Deaprtment |
| Address |
Physiotherapy Department Punjabi
University Patiala
Punjab
147002
India
Patiala
PUNJAB
147002
India |
| Phone |
9914889469 |
| Fax |
|
| Email |
jayaraman_mpt@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Prabhjot Kaur Kaler |
| Designation |
Postgraduate Student |
| Affiliation |
Physiotherapy Department |
| Address |
Physiotherapy Department Punjabi University Patiala Punjab
147002
India
Patiala
PUNJAB
147002
India |
| Phone |
7508150011 |
| Fax |
|
| Email |
rabhiejot.786@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Prabhjot Kaur Kaler |
| Address |
Physiotherapy Department Punjabi University Patiala 147002 |
| 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 Jayaraman G |
Department Of Physiotherapy bhai Kanhaiya OPD 1 and 2 |
Department of Physiotherapy Punjabi University Patiala
Punjab
India 147002
Patiala
PUNJAB |
9914889469
jayaraman_mpt@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E139||Other specified diabetes mellituswithout complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
control group group B |
Participants in the control group will continue their usual daily activities and prescribed medical treatment without any physiotherapy intervention and will be instructed to avoid caffeine, alcohol and exercise for at least two hours prior to blood pressure measurements. All physiological readings will be taken in the morning at the same time each day with two measurements recorded five minutes apart and the average value considered for analysis |
| Intervention |
experimental group group A |
Participants in the experimental group will be instructed to perform slow deep breathing in a quiet and comfortable environment free from distractions either in a relaxed seated position with back support or in a supine lying position. They will be asked to close their eyes and focus on their breathing throughout the session. The breathing technique will involve slow and deep inhalation with abdominal expansion for 4 to 5 seconds followed by a brief pause of 1 to 2 seconds at the end of inhalation and then slow controlled exhalation with abdominal contraction for 7 to 8 seconds in a selfpaced rhythm. A breathing rate of approximately six breaths per minute corresponding to one complete breath every ten seconds will be maintained. Each session will last for 15 minutes and will be performed twice daily at fixed timings for a duration of four weeks |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed hypertensive stage 1 and 2 diabetic patients DM2
Age between 35 and 65 years old
On hypertensive medication more than 6 months |
|
| ExclusionCriteria |
| Details |
Patients with history of chronic kidney disease
History of recent cardiovascular event myocardial infarction less than 6 months
History of chronic respiratory diseases
Any known stress related disorder
Engaged in yoga or other breathing practices |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Blood Pressure
Systolic Blood Pressure (SBP)
Diastolic Blood Pressure (DBP) |
at baseline, at 7th day, 14th dat,21st day and 28th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Heart rate
Respiratory rate
Oxygen saturation |
at baseline, on 7th day, 14th 21st day, and 28th day |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
16/03/2026 |
| 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="0"
Months="6"
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
|
The present study aimed to determine the effect of slow deep breathing exercise on blood pressure in patients with hypertensive diabetes mellitus. Hypertension and diabetes mellitus commonly coexist and significantly increase the risk of cardiovascular complications, making effective blood pressure control essential in this high-risk population. Although pharmacological management is widely used, non-pharmacological interventions such as breathing exercises are gaining importance as complementary strategies. An experimental pre and post intervention study with a control group will be conducted on 30 participants aged 35–65 years diagnosed with hypertension and type 2 diabetes mellitus. Participants will be randomly divided into experimental and control groups, with 15 subjects in each group. The experimental group will perform slow deep breathing at a rate of six breaths per minute for 15 minutes twice daily for four weeks, while the control group will continue routine care without physiotherapy intervention. Baseline and post-intervention measurements of systolic and diastolic blood pressure, respiratory rate, heart rate, and oxygen saturation will be recorded and analysed The study will evaluate the effectiveness of slow deep breathing as a safe, low-cost, and accessible physiotherapy intervention |