| CTRI Number |
CTRI/2025/10/096384 [Registered on: 23/10/2025] Trial Registered Prospectively |
| Last Modified On: |
23/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of breathing muscle release and manual rib mobilization on the expansion of lungs and chest in patients that have undergone cardiac surgery |
|
Scientific Title of Study
|
Combined effect of diaphragmatic myofacial release and rib mobilisation on chest wall expansion and pulmonary function in post CABG patients A randomised 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 |
Sanjiv Kumar |
| Designation |
Principal |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Room No. 39, Advanced Physiotherapy Centre, G-1, KAHER Institute of Physiotherapy, Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9448745648 |
| Fax |
|
| Email |
principalkipt@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anastasia Carvalho |
| Designation |
Undergraduate Intern |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Room No. 39, Advanced Physiotherapy Centre, G-1, KAHER Institute of Physiotherapy, Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590011
India |
| Phone |
7829851640 |
| Fax |
|
| Email |
anastasia30st@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anastasia Carvalho |
| Designation |
Undergraduate Intern |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Room No. 39, Advanced Physiotherapy Centre, G-1, KAHER Institute of Physiotherapy, Nehru Nagar, Belagavi
Belgaum
KARNATAKA
590011
India |
| Phone |
7829851640 |
| Fax |
|
| Email |
anastasia30st@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Anastasia Carvalho |
| Address |
Casa Carvalho, Plot No.5, Somnath Colony, 6th cross Adarsh Nagar, Hindwadi, Belagavi 590011 |
| Type of Sponsor |
Other [Self funded] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Aditi Shedbal |
Mahantesh Nagar, Belagavi |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anastasia Carvalho |
KLE Hospital |
Cardiac Post operative ward, G+1, KLE Hospital, Nehru Nagar, Belgaum 590010
Belgaum
KARNATAKA |
7829851640
-
anastasia30st@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I278||Other specified pulmonary heart diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Combined effect of diaphragmatic myofascial release and rib mobilisation along with standard cardiac physiotherapy rehab |
Diaphrammatic Myofascial release
Parameters: 10 breaths with 1 min break from each, 2 rounds
Rib mobilization: Techniques used- thoracic vertebrae P-A glide from T1-T12 and rib glide grade 1-2
Followed by standard physiotherapy cardiac rehab
|
| Comparator Agent |
Standard cardiac physiotherapy protocol |
Diaphragmatic breathing exercise – 5 repetitions, 3 sets, 4 times a day
AAROM for bilateral Upper limb and lower limbs- 5 repetitions, 3 sets, 4 times a day
Ankle toe movements – 5 repetitions, 3 sets, 4 times a day
Thoracic mobility exercises – 5 repetitions, 2 sets, 4 times a day
Splinted huffing – 3-4 huffs, 3 times a day
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who are willing to participate in the study and who are aged between 40 and
80 years who have undergone uncomplicated coronary artery bypass grafting
(CABG).
2. Participants must be on postoperative day three and have no in-situ drains.
3. They should be medically and hemodynamically stable, with stable vital signs
including blood pressure, heart rate, and respiratory rate.
4. Patients must be able to comprehend and follow verbal instructions to actively
participate in the rehabilitation program. |
|
| ExclusionCriteria |
| Details |
1. Patients with uncontrolled arrhythmias are excluded from the study.
2. Any postoperative complications, like embolism, thrombus and others as diagnosed
by the on-duty surgeon, will disqualify participation.
3. Participants with infected suture lines are not eligible
4. Individuals with rib fractures or other thoracic skeletal fractures will be excluded
from the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Scalar measurement of chest wall expansion
Breath hold time
Forced expiratory Volume1 and Forced Vital Capacity
Peak expiratory flow rate
EURO QoL 5D |
Post operative day 3 and post operative day 6
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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 2 |
|
Date of First Enrollment (India)
|
03/11/2025 |
| 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="0"
Months="6"
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 is a randomized controlled trial single blinded trial aims to evaluate the effect of diaphragmatic myofascial release and rib mobilization on chest wall expansion and pulmonary function in post operative CABG patients. A total of 32 participants undergoing CABG will be randomly assigned into 2 groups. The control group recieves standard physiotherapy care like deep breathing exercises thoracic expansion and incentive spirometry and the intervention group receiving same standard care along with DMFR and rib mobilization once daily from post operative day 3 to day 6. Outcome measures including chest wall expansion FEV1 FVC and breath hold time and 1 minute sit to stand will be assessed pre and post. The study seeks to determine whether incorporating manual therapy techniques enhances respiratory mechanics and funtional recovery following CABG. |