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CTRI Number  CTRI/2025/03/082174 [Registered on: 12/03/2025] Trial Registered Prospectively
Last Modified On: 28/02/2025
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   Effect of Breathing Exercises with and without Device Combined with Endurance Training on Lung Health and Fitness in Obese People with High Blood Pressure An Experimental Study 
Scientific Title of Study   Effect of Instrumented and Non Instrumented Breathing Exercise Along With Endurance Training On Pulmonary Functions And Functional Capacity Of Obese Hypertensive Individuals An Experimental Study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Bhiniksha Mandlik 
Designation  Post Graduation 
Affiliation  Datta Meghe College of Physiotherapy 
Address  Department of Cardiovascular and Respiratory Physiotherapy Datta Meghe College Of Physiotherapy Shri Datta Meghe Polytechnic Campus Wanadongri Hingna Road Nagpur MAHARASHTRA 441110 INDIA

Nagpur
MAHARASHTRA
441110
India 
Phone  7020690618  
Fax    
Email  bhinikshamandlik28@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sachin Annaji Chaudhary 
Designation  Principal and Professor 
Affiliation  Datta Meghe College Of Physiotherapy 
Address  Department of Cardiovascular and Respiratory Physiotherapy, Datta Meghe College Of Physiotherapy, Shri Datta Meghe Polytechnic Campus, Wanadongri, Hingna Road , Nagpur MAHARASHTRA 441110 INDIA

Nagpur
MAHARASHTRA
441110
India 
Phone  9960898805  
Fax    
Email  drsachin1982@gmail.com  
 
Details of Contact Person
Public Query  
Name  Bhiniksha Mandlik 
Designation  Post Graduation 
Affiliation  Datta Meghe College Of Physiotherapy 
Address  Department of Cardiovascular and Respiratory Physiotherapy, Datta Meghe College Of Physiotherapy, Shri Datta Meghe Polytechnic Campus, Wanadongri, Hingna Road , Nagpur MAHARASHTRA 441110 INDIA

Nagpur
MAHARASHTRA
441110
India 
Phone  7020690618  
Fax    
Email  bhinikshamandlik28@gmail.com  
 
Source of Monetary or Material Support  
Datta Meghe College Of Physiotherapy wanadongri Hingna Road Nagpur Maharashtra India 441110  
 
Primary Sponsor  
Name  Datta Meghe College Of Physiotherapy 
Address  Datta Meghe College Of Physiotherapy, Shri Datta Meghe Polytechnic Campus, Wanadongri, Hingna Road , Nagpur MAHARASHTRA 441110 INDIA 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Bhiniksha Mandlik  Datta Meghe College Of Physiotherapy  Cardiovascular and Respiratory Physiotherapy OPD room no 4 Datta Meghe College Of Physiotherapy Shri Datta Meghe Polytechnic Campus Wanadongri Hingna Road Nagpur MAHARASHTRA 441110 INDIA
Nagpur
MAHARASHTRA 		 7020690618

bhinikshamandlik28@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committe (IEC)   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E668||Other obesity,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Incntive Spirometry with Endurance Training  The intervention group will receive incentive spirometer exercise for 15 minutes, 5days/week for 4 weeks and Endurance training which is gradually increasing from 5 minutes of stationary cycling and 5 minutes of treadmill in 1st week to 10 minutes of stationary cycling and 10 minutes of treadmill in 2nd week to 15 minutes of stationary cycling and 15 minutes treadmill in 3rd and 4th week for 5days / week, spanning over 4 weeks. 
Comparator Agent  Inspiratory Diaphragmatic Breathing and Expiratory Pursed Lip Breathing Exercise with Endurance Training  The other group will recieve Inspiratory Diaphragmatic Breathing and Expiratory Pursed Lip Breathing Exercise for 15 minutes, 5days/week for 4 weeks and Endurance training which is gradually increasing from 5 minutes of stationary cycling and 5 minutes of treadmill in 1st week to 10 minutes of stationary cycling and 10 minutes of treadmill in 2nd week to 15 minutes of stationary cycling and 15 minutes treadmill in 3rd and 4th week for 5days / week, spanning over 4 weeks. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Participants who are willing to participate.
2.History of hypertension ≥5 years.
3.Hypertensive individuals with BP ≥ 140/90 mmHg.
4.Obese individuals with BMI of ≥ 30 kg/m2.
 
 
ExclusionCriteria 
Details  1.History of Smoking and Diabetes.
2.Presence of any chronic pulmonary disease, neuromuscular disease, cardiovascular disease other than Hypertension.
3.Airway infection or acute asthma in a month before enrolment and during the study.
4.Severe orthopedic problems with a significant impact on daily activities.
5.Presence of any psychiatric or cognitive disorder.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess the pulmonary functions with the help of Pulmonary Function Tests (FVC, FEV1, PEF and FVC/FEV1)  Pre-intervention and Post-intervention 4th week. 
 
Secondary Outcome  
Outcome  TimePoints 
To check the endurance with the help of 6MWT (distance walked)   Pre-intervention and Post-intervention 4th week. 
 
Target Sample Size   Total Sample Size="130"
Sample Size from India="130" 
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)   17/03/2025 
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  
This study focuses on assessing the impact of instrumented and non-instrumented breathing exercises, combined with endurance training, on the pulmonary functions and functional capacity of obese hypertensive individuals. Hypertension and obesity are significant global health concerns, often occurring together, and are associated with impaired pulmonary function, reduced exercise tolerance, and an increased risk of cardiovascular diseases. Effective interventions are needed to address these complications and improve the quality of life for affected individuals.

The study will include 130 participants aged 30-60 years with a history of hypertension (≥5 years) and obesity (BMI ≥30 kg/m²). Participants will be divided into two groups. Group 1 will perform endurance training combined with incentive spirometry, while Group 2 will perform endurance training combined with inspiratory diaphragm breathing (IDB) and expiratory pursed-lip breathing (EPLB) exercises. Both groups will follow a structured 4-week program consisting of treadmill and cycling exercises at low intensity (not exceeding 20% of HRR), gradually increasing in duration over the weeks. Each group will also perform their respective breathing exercises for 15 minutes, 5 days a week.

Outcome measures include pulmonary function tests (FVC, FEV1, PEF) and functional capacity, assessed through the 6-minute walk test (6MWT), will be measured before and after the intervention. By comparing the results, the study aims to determine the effectiveness of instrumented versus non-instrumented breathing exercises in improving respiratory health and functional endurance.

This research is designed to explore optimal rehabilitation strategies for obese hypertensive individuals, offering evidence-based approaches to enhance lung function, exercise tolerance, and overall well-being.
 
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