| CTRI Number |
CTRI/2024/12/077914 [Registered on: 10/12/2024] Trial Registered Prospectively |
| Last Modified On: |
09/12/2024 |
| 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 Training and Expiratory Muscle Training on CABG patient |
|
Scientific Title of Study
|
Effects of Threshold IMT and Threshold PEP IMT on Cardiopulmonary parameters, Anxiety and depression in Post CABG patient: A Comparative 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 |
UPASNA |
| Designation |
PG Student |
| Affiliation |
SGT University |
| Address |
Faculty of Physiotherapy,
SGT University, Chandu, Budhera
Haryana
Gurgaon
HARYANA
122505
India |
| Phone |
08447227843 |
| Fax |
|
| Email |
upasnachoudhary52@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. NEHA REYALCH |
| Designation |
Assistant Professor |
| Affiliation |
SGT University |
| Address |
Faculty of Physiotherapy,
SGT University, Chandu, budhera
Gurugram, Haryana
Gurgaon
HARYANA
122505
India |
| Phone |
8826043916 |
| Fax |
|
| Email |
neha_fphy@sgtuniversity.org |
|
Details of Contact Person
Public Query
|
| Name |
UPASNA |
| Designation |
Student |
| Affiliation |
SGT University |
| Address |
Faculty of Physiotherapy,
SGT University
chandu, Budhera
Gurugram, Haryana
Gurgaon
HARYANA
122505
India |
| Phone |
08447227843 |
| Fax |
|
| Email |
upasnachoudhary52@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Heart Institute
49 50 Community Center, East of Kailash, New Delhi, Delhi 110065 |
|
|
Primary Sponsor
|
| Name |
UPASNA |
| Address |
SGT UNIVERSITY
Budhera, Gurugram-Badli Road, Gurugram- 122505, Haryana |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Upasna |
National Heart Institute |
Department of Physiotherapy,
49 50 Community center, East of Kailash, New Delhi 110065
New Delhi
DELHI |
08447227843
upasnachoudhary52@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Faculty of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I703||Atherosclerosis of unspecified type of bypass graft(s) of the extremities, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group-1-Inspiratory Muscle Training with Conventional Chest physiotherapy |
Patient will Perform the IMT Training with IMT Respironics Threshold device and during the intensive care unit stay (30 deep breaths, twice daily) against resistance equal to 30% of Maximum Inspiratory Pressure and Conventional Chest physiotherapy which include bronchial hygiene therapy and deep breathing. |
| Intervention |
Group-2-Expiratory Muscle Training with Conventional chest physiotherapy |
Patient will perform the PEP IMT Training twice a day day with three sets of 10 repetitions (For Expiratory Muscles) along with Conventional Chest Physiotherapy which include bronchial hygiene therapy and deep breathing. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient with CAD- cardiopulmonary bypass and sternotomy.
The Study will include men and women older than 30years old. |
|
| ExclusionCriteria |
| Details |
Any systemic disorder (Ileus, Cancer)
Intra-arotic balloon
Heart valve disease
Unwillingness to continue the exercise session
Patient having uncontrolled fever
Uncooperative patient
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Inspiratory Muscle Strength
Expiratory Muscle Strength |
DAY 1 ASSESSMENT
DAY 7 ASSESSMENT |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Pulmonary function
2.Cardiac surgery stressors Scale
3.Hospital Anxiety and depression Scale
|
DAY 1 ASSESMENT
DAY 7 ASSESMENT |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
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)
|
20/12/2024 |
| 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="6" |
|
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
|
CABG surgery can significantly affect the cardiopulmonary system. Postoperative patients often experience reduced lung function and overall cardiopulmonary fitness. Postoperative anxiety and depression are common in CABG patients due to physical limitations, pain, and the psychological impact . The Coronary Artery bypass graft surgery (CABG) is done to treat blockage or narrowing of 1 or more of the coronary artery. It can restore the blood supply to the heart muscle when non-surgical procedures are not a choice. Threshold IMT and threshold PEP IMT was more effective in increasing muscle strength. Effects of threshold IMT and threshold PEP IMT on coronary artery bypass graft (CABG) lies in its potential to improve respiratory function, alleviate cardiac stress, anxiety and depression in a population at high risk for cardiac disorders. Hypothesis: Null hypothesis H01: There will be no significant difference in Cardiopulmonary parameter following threshold inspiratory muscle training after CABG surgery compared to those who do not receive this intervention. H02: There will be no significant difference in Cardiopulmonary parameter following threshold expiratory muscle training after CABG surgery compared to those who do not receive this intervention. H03: There will be no significant difference in Anxiety and depression following threshold inspiratory muscle training after CABG surgery compared to those who do not receive this intervention. H04: There will be no significant difference in Anxiety and depression following threshold expiratory muscle training after CABG surgery compared to those who do not receive this intervention. Alternate Hypothesis H11: There will be significant difference in Cardiopulmonary parameter following threshold inspiratory muscle training after CABG surgery compared to those who do not receive this intervention. H12: There will be no significant difference in Cardiopulmonary parameter following threshold expiratory muscle training after CABG surgery compared to those who do not receive this intervention. H13: There will be significant difference in Anxiety and depression following threshold inspiratory muscle training after CABG surgery compared to those who do not receive this intervention. H14: There will be significant difference in Anxiety and depression following threshold expiratory muscle training after CABG surgery compared to those who do not receive this intervention |