| CTRI Number |
CTRI/2026/03/106459 [Registered on: 18/03/2026] Trial Registered Prospectively |
| Last Modified On: |
17/03/2026 |
| 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
|
Breathing Exercises and Early Movement to Improve Lung Function in Children After Heart Surgery: A Pilot Study |
|
Scientific Title of Study
|
Effect Of Inspiratory Muscle Training and Early Mobilization to Improve Oxygenation and Pulmonary Functions in Patients with Pediatric Cardiac Surgery: A Pilot Randomized Controlled Trial |
| 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 Sanika Girish Khawase |
| Designation |
Postgraduate Student |
| Affiliation |
MGM Institute of Physiotherapy |
| Address |
Department of Cardiovascular and respiratory physiotherapy, MGM Institute of Physiotherapy,Chh Sambhajinagar
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9503224053 |
| Fax |
|
| Email |
sanikaphysio28@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vaibhav Kapre |
| Designation |
Professor |
| Affiliation |
MGM Institute of Physiotherapy |
| Address |
Department of Cardiovascular and respiratory physiotherapy, MGM Institute of Physiotherapy,Chh Sambhajinagar
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9425346903 |
| Fax |
|
| Email |
vaibhavkapre@mgmiop.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaibhav Kapre |
| Designation |
Professor |
| Affiliation |
MGM Institute of Physiotherapy |
| Address |
Department of Cardiovascular and respiratory physiotherapy, MGM Institute of Physiotherapy,Chh Sambhajinagar
MAHARASHTRA
431003
India |
| Phone |
9425346903 |
| Fax |
|
| Email |
vaibhavkapre@mgmiop.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
MGM Institute of Physiotherapy |
| Address |
N-6,Cidco, Chhatrapati Sambhajinagar, 431003, 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 |
| Dr Sanika Girish Khawase |
MGM Institute of Physiotherapy |
Department of Cardiovascular and respiratory physiotherapy, MGM Institute of Physiotherapy,Chh Sambhajinagar
Aurangabad
MAHARASHTRA |
9503224053
sanikaphysio28@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE FOR RESEARCH ON HUMAN SUBJECTS,Department of Pharmacology , MGM Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I52||Other heart disorders in diseasesclassified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inspiratory Muscle training and early mobilisation |
The intervention group includes inspiratory muscle training using an inspiratory muscle trainer combined with early mobilization according to the Leuven protocol in pediatric patients following cardiac surgery. this intervention will be given for 6 days a week for a period of 1 week after the surgery.
|
| Comparator Agent |
Usual Physiotherapy Care |
The control group will receive the usual physiotherapy protocol, including basic breathing exercises and mobility training. This intervention will be given for a period of 6 days/ week for 1 week after the surgery. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1. Both Male and female
2. Age 4-14 years
3. Both Invasive and Non-Invasive cardiac surgery procedures |
|
| ExclusionCriteria |
| Details |
1. Unstable patients
2. Patients with any neurological defect (eg- spina bifida,cerebral palsy)
3. Patients on mechanical ventilation support. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Oxygenation
2. Pulmonary Functions-Pimax
3. ABG Analysis-pH.PCO2 |
At baseline and on the 6th day of the surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Heart Rate
2. respiratory Rate
3. Pain |
At baseline and on the 6th day of the surgery |
|
|
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
28/03/2026 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
Male or female participants age 4-14 years are included in the study based on specific eligibility criteria. Informed written and verbal consent will be obtained from the parents of the participants before data collection. Demographic information including name age gender relevant medical and surgical history will be documented. All outcome variables will be measured on the first day before intervention, and on 6th day of surgery participants will be randomly allocated into 2 groups using block randomization: the interventional group will receive inspiratory muscle training with early mobilisation , while the control group will receive usual physiotherapeutic care. The outcome measure will include Oxygenation, Pulmonary functions, ABG Analysis, Heart rate, respiratory rate, Pain and the final conclusion will be drawn based on the comparative effectiveness of the intervention. |