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CTRI Number  CTRI/2025/09/094647 [Registered on: 11/09/2025] Trial Registered Prospectively
Last Modified On: 22/08/2025
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   Inspiratory Muscle Trainer on pulmonary function and functional capacities in cardiac rehabilitation 
Scientific Title of Study   Effectiveness of inspiratory muscle trainer on pulmonary function and functional capacities in phase 1 cardiac rehabilitation  
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 Nigam Subhash Nagdeve 
Designation  Postgraduate Student  
Affiliation  Datta Meghe College Of Physiotherapy ,Nagpur 
Address  Department of Cardiovascular and Respiratory Physiotherapy Datta Meghe College Of Physiotherapy Shri Datta Meghe Polytechnic Campus Wanadongri Hingna Road Nagpur MAHARASHTRA 441110 INDIA
Department of Cardiovascular and Respiratory Physiotherapy Datta Meghe College Of Physiotherapy Shri Datta Meghe Polytechnic Campus Wanadongri
Nagpur
MAHARASHTRA
441110
India 
Phone  09423695882  
Fax    
Email  nigamnagdeve@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Manish Shukla 
Designation  Professor 
Affiliation  Datta Meghe College Of Physiotherapy ,Nagpur 
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  9960290614  
Fax    
Email  manish.shukla20@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nigam Subhash Nagdeve 
Designation  Postgraduate Student 
Affiliation  Datta Meghe College Of Physiotherapy ,Nagpur 
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  09423695882  
Fax    
Email  nigamnagdeve@gmail.com  
 
Source of Monetary or Material Support  
Datta meghe college of physiotherapy, nagpur 441110 maharashtra india  
 
Primary Sponsor  
Name  Dr Nigam Subhash Nagdeve 
Address  Datta meghe college of physiotherapy Nagpur 441110 maharashtra 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 
DrNigam Subhash Nagdeve  Dr.Babasaheb Ambedkar Research Institute   Ward no. 16 cardiothoracic surgery unit Stepdown unit near EMD department ground floor, Dr. BabaSaheb Ambedkar superspeciality institute
Nagpur
MAHARASHTRA 
09423695882

nigamnagdeve@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Datta Meghe Ayurved,Physiotherapy,nursing (APN)Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I778||Other specified disorders of arteries and arterioles,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  control group   Breathing techniques Active range of motion exercises (ankle, foot, finger, and wrist movements) are performed. Static glutes and quadriceps.  
Intervention  Inspiratory muscle trainer   Frequency six breath Intensity twice a day for four days Rest period for 60 seconds Time 35 minute  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1 A minimum 40% ejection fraction
2 Heart valve surgery, left or right
3 Minimum age of eighteen years
4 NYHA I–III stable heart failure CABG
5 Coronary artery percutaneous intervention
 
 
ExclusionCriteria 
Details  BP higher than 200mg in systolic and 110 in diastolic ,ischemic ECG alteration, uncontrolled tachycardia instable angina, AV block of third degree 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Inspiratory muscle trainer  Postoperative day 1
Postoperative day 6 
 
Secondary Outcome  
Outcome  TimePoints 
6 Minute walk test  Postoperative day 1
Postoperative day 6 
 
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)   11/09/2025 
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  
Cardiac rehabilitation is defined by the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) as the delivery of all-inclusive, long-term services that include medical evaluation, prescription exercise, modification of cardiac risk factors, education, counseling, and behavioral interventions. The inspiratory muscle trainer device benefits includes improved pulmonary function, respiratory muscle strength and endurance, functional capacity, physical activity, and health-related quality of life used  patients.Efficacy of inspiratory muscle trainer during Phase 1 of cardiac rehabilitation has not been well studied.
This randomized clinical trial aimed to evaluate and  the effects of Inspiratory muscle trainer  who underwent  Phase 1 of their cardiac rehabilitation. 
Procedure : Participants will be selected and screened based on inclusion and exclusion criteria. Details about the study and intervention will be explained to the participants and an informed written consent form will be obtained. Patient’s will be Randomly divided through block randomisation method into Group A (control  ) and Group B ( IMT). Outcomes will be assessed on pod 1 and treatment will be given from POD 2 to POD 6 to Patients who underwent through cardiac rehabilitation  On Postoperative day 6 outcomes will be reassessed. Data will be collected from both groups and analyzed for significant differences in pulmonary function and airway clearance improvements. Statistical tests will be used to compare the efficacy of inspiratory muscle trainer  devices in enhancing respiratory outcomes in phase 1 cardiac rehab patients.

 
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