| 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
|
|
|
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
|
|
|
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.
|