| CTRI Number |
CTRI/2026/01/102583 [Registered on: 30/01/2026] Trial Registered Prospectively |
| Last Modified On: |
29/01/2026 |
| 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
|
Comparision on the effect of different breathing muscle training intensities on blood pressure and nerve function in patients with high blood pressure |
|
Scientific Title of Study
|
Comparing The Effect Of High Intensity vs Low Intensity Inspiratory Muscle Training on Blood Pressure And Autonomic Function on Hypertensive Patients |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NASSEM E |
| Designation |
Post Graduate student |
| Affiliation |
Durgabai Deshmukh Hospital And Research Centre |
| Address |
26Q7C Vidhya Nagar OU ROAD Adikmmet Hyderabad
Hyderabad
TELANGANA
500044
India |
| Phone |
9361352817 |
| Fax |
|
| Email |
naseemebrahim1630@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
N SIVA JYOTHI |
| Designation |
Associate Professor |
| Affiliation |
Durgabai Deshmukh Hospital And Research Centre |
| Address |
26Q7C Vidhya Nagar OU ROAD Adikmmet Hyderdrabad
Hyderabad
TELANGANA
500044
India |
| Phone |
9866176055 |
| Fax |
|
| Email |
sivajyothimpt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
N SIVA JYOTHI |
| Designation |
Associate Professor |
| Affiliation |
Durgabai Deshmukh College Of Physiotherapy |
| Address |
26Q7C Vidhya Nagar Adikmmet Hyderabad
Hyderabad
TELANGANA
500044
India |
| Phone |
9866176055 |
| Fax |
|
| Email |
sivajyothimpt@gmail.com |
|
|
Source of Monetary or Material Support
|
| NASEEM E
Vidhya Nagar OU ROAD Adikmet Hyderabad Telangana 500044 |
|
|
Primary Sponsor
|
| Name |
NASEEM E |
| Address |
Vidhya Nagar OU ROAD Adikmet Hyderabad TG 500044 |
| 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 NASEEM |
Durgabai Deshmukh Outpatient Department Of Physiotherapy |
Durgabai deshmukh Hospital OutPatient DEPT Of Physiotherapy Ground Floor Block 1 26Q7C Vidhya Nagar Adikmet OU ROAD
Hyderabad
TELANGANA |
9361352817
naseemebrahim1630@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee Durgabai deshmukh hospital and research centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I158||Other secondary hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GROUP A High intensity IMT |
High Intensity inspiratory training group will be performed at 50-60% of PI max training using a inspiratory muscle trainer 30 breaths per session once daily 3 days per week 2 days home program followed with 2 rest days for upto 6 weeks |
| Comparator Agent |
GROUP B Low Intensity IMT |
low Intensity inspiratory training group will be performed at 30-45% of PI max training using a inspiratory muscle trainer 30 breaths per session once daily 3 days per week 2 days home program followed with 2 rest days for upto 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed with stage 1-2 essential hypertension
on stable antihypertensive medication below or equal to 4 weeks
able to understand and follow instructions |
|
| ExclusionCriteria |
| Details |
Secondary Hypertension
Severe cardiac or pulmonary or renal disease
Neurological disorders like stroke or neuropathies
Current smoker or Alcohol dependence
Participation in structured respiratory training programs in past 6 months |
|
|
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 |
systolic and diastolic blood pressure using bp monitor
HRV indices
PI max strength |
pre assessment and post assessment after 6 weeks of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| PI max strength using capsule sensing pressure aguge meter |
pre assesment before the treatment post assesment after 6 weeks of intervention |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
16/02/2026 |
| 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)
|
Not Yet Recruiting |
| 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 study is to compare the effect of high intensity vs low intensity inspiratory muscle training on blood pressure and autonomic function in hypertensive patients by assesing thier systolin and diastolic blood pressure ,heart rate variability and inspiratory muscle strength PI MAX. where the patients will be treated for with 6 weeks intervention period post assessment we will know which training shows better improving among hypertensive patients.thus,this study provides evidence for clinical apllication of IMT in hypertensive ptients |