| CTRI Number |
CTRI/2021/10/037275 [Registered on: 12/10/2021] Trial Registered Prospectively |
| Last Modified On: |
08/10/2021 |
| 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
|
to determine the effect of expiratory muscle training on expiratory muscle strength in patients undergone CABG |
|
Scientific Title of Study
|
Effectiveness of expiratory muscle training and conventional Physiotherapy on Peak expiratory flow rate and expiratory muscle strength in patients with CABG: A double blinded Randomized control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
HRIDAYA JITENDRA JOSHI |
| Designation |
MPT1 CARDIO RESPIRATORY SCIENCES |
| Affiliation |
Dr. Vithalrao Vikhe Patil Foundations College of Physiotherapy |
| Address |
Dr. Vithalrao Vikhe Patil Foundations College of Physiotherapy, Opp. Govt. Milk Diary, Vadgaon Gupta, Ahmednagar
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
9767534918 |
| Fax |
|
| Email |
hridayajoshi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ABHIJIT DILIPRAO DIWATE |
| Designation |
PROFESSOR AND HOD |
| Affiliation |
Dr. Vithalrao Vikhe Patil Foundations College of Physiotherapy |
| Address |
Dr. Vithalrao Vikhe Patil Foundations College of Physiotherapy, Opp. Govt. Milk Diary, Vadgaon Gupta, Ahmednagar
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
8554990222 |
| Fax |
|
| Email |
abhijitdiwate@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ABHIJIT DILIPRAO DIWATE |
| Designation |
PROFESSOR AND HOD |
| Affiliation |
Dr. Vithalrao Vikhe Patil Foundations College of Physiotherapy |
| Address |
Dr. Vithalrao Vikhe Patil Foundations College of Physiotherapy, Opp. Govt. Milk Diary, Vadgaon Gupta, Ahmednagar
Ahmadnagar
MAHARASHTRA
414111
India |
| Phone |
8554990222 |
| Fax |
|
| Email |
abhijitdiwate@gmail.com |
|
|
Source of Monetary or Material Support
|
| DVVPFS COLLEGE OF PHYSIOTHERAPY, AHMADNAGAR |
|
|
Primary Sponsor
|
| Name |
DVVPFS COLLEGE OF PHYSIOTHERAPY |
| Address |
Dr. Vithalrao Vikhe Patil Foundations College of Physiotherapy, Opp. Govt. Milk Diary, Vadgaon Gupta, Ahmednagar |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Hridaya Joshi |
DVVPS |
Dr. Vithalrao Vikhe Patil Foundations College of Physiotherapy, Opp. Govt. Milk Diary, Vadgaon Gupta, Ahmednagar
Ahmadnagar
MAHARASHTRA |
8830548730
hridayajoshi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vitthalrao Vikhe Patil College of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I708||Atherosclerosis of other arteries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Expiratory Muscle Training |
Use of EMST and use IMST |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients planned for CABG |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
PEFR
MEP
|
PEFR assessed Pre-operatively, POD1 and POD7
MEP assessed Pre-operatively, POD1 and POD7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
PEFR
MEP |
1 year |
|
|
Target Sample Size
|
Total Sample Size="58"
Sample Size from India="58"
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 1 |
|
Date of First Enrollment (India)
|
01/11/2021 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
the study aims to strengthen the expiratory muscles in order to see the effects of the training on the respiratory muscle strength patients who are under going coronary artery bypass grafting. |