| CTRI Number |
CTRI/2023/04/052116 [Registered on: 28/04/2023] Trial Registered Prospectively |
| Last Modified On: |
26/04/2023 |
| 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
|
Efficacy of Powerbreathe medic plus Device in Coronary Artery Bypass Graft Patients
|
|
Scientific Title of Study
|
Efficacy of Powerbreathe medic plus Device on maximal inspiratory pressure, functional capacity and quality of life in Coronary Artery Bypass Graft Patients: A randomized controlled trial
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrVishnu Vardhan |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Ravi Nair Physiotherapy College, Cardiovascular and Respiratory Physiotherapy Department Datta Meghe Institute of Higher Education and Research,Sawangi (Meghe) Meghdoot Appartments,G1 4,Sawangi ( Meghe) Wardha MAHARASHTRA 442001 India |
| Phone |
8379917421 |
| Fax |
|
| Email |
vishnudiwakarpt@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DrVishnu Vardhan |
| Designation |
Professor |
| Affiliation |
Ravi Nair Physiotherapy College,Datta Meghe Institute of Higher Education and Research |
| Address |
Ravi Nair Physiotherapy College Cardiovascular and Respiratory Physiotherapy Department Datta Meghe Institute of Higher Education and ResearchSawangi (Meghe) Meghdoot Appartments,G1 4,Sawangi ( Meghe) Wardha MAHARASHTRA 442001 India |
| Phone |
8379917421 |
| Fax |
|
| Email |
vishnudiwakarpt@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DrVishnu Vardhan |
| Designation |
Professor |
| Affiliation |
Ravi Nair Physiotherapy College,Datta Meghe Institute of Higher Education and Research |
| Address |
Ravi Nair Physiotherapy College Cardiovascular and Respiratory Physiotherapy Department Datta Meghe Institute of Higher Education and Research,Sawangi (Meghe) Meghdoot Appartments,G1 4,Sawangi ( Meghe) Wardha MAHARASHTRA 442001 India |
| Phone |
8379917421 |
| Fax |
|
| Email |
vishnudiwakarpt@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Reseach has funded for Respiratory MicroRPM Respiratory Pressure Meter Device. |
|
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Primary Sponsor
|
| Name |
Ravi Nair Physiotherapy College,Datta Meghe Institute of Higher Education & Research |
| Address |
Ravi Nair Physiotherapy College,Datta Meghe Institute of Higher Education & Research |
| 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 |
| DrVishnu Vardhan |
Acharya Vinobha Bhave Rural Hospital |
Cardiovascular Surgery Department, Sawangi
( Meghe) Wardha MAHARASHTRA |
8379917421
vishnudiwakarpt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITEE- DATTA MEGHE INSTITUTE OF MEDICAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I798||Other disorders of arteries, arterioles and capillaries in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Chest Physiotherapy exercises |
Conventional Chest Physiotherapy exercises will be given in the form of Diaphragmatic breathing exercise,Thorasic expansion exercises,Incentive spirometry.he duration of intervention is given for two weeks. |
| Intervention |
Powerbreathe Medic Plus Device |
This is a respiratory device that uses Respiratory Muscle Training (RMT) against resistance to improve respiratory muscle strength by breathing through various sized orifices. The device improves both inspiratory and expiratory muscle strength by applying resistance to both portions of the breath cycle. It may be adjusted and has its power source. The duration of intervention is given for two weeks. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients who will sign the informed consent form.
2.Both the male and female patients.
3.Patients who had undergone Coronary artery bypass graft patients with age group of 40-70 years.
|
|
| ExclusionCriteria |
| Details |
1. Patients who had developed hemodynamic complications (e.g. preoperative Myocardial Infarction, Lung Congestion, Post-operative renal failure, patients on Intra-aortic balloon pump or arrhythmia needed for a pacemaker).
2. CABG patient on Post-operative mechanical ventilation (more than 24 hours).
3. No previous neurological complications in last 6 months.
4. Unstable angina
|
|
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Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
• Maximal Inspiratory Pressure (PImax)
• Six minute walk distance
|
Two Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Six Minute Walk Distance |
Two Weeks |
|
|
Target Sample Size
|
Total Sample Size="44" Sample Size from India="44"
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)
|
30/04/2023 |
| 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="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In cardiac surgery patients, decreased Respiratory Muscle Strength has been associated with decreased functional capacity and has contributed to a prolonged period of recovery of lung function and the occurrence of physical deconditioning, which can last for several weeks. Respiratory repercussions also generate changes in RMS, as well as changes in lung volumes and capacities, alveolar dysfunction, depression of central respiratory stimulation, and mechanical disorders of thoracic function. In addition, it is known that most cardiac surgery patients present with episodes of muscle weakness in the preoperative period, which is accentuated after the surgical procedure. However, this muscle weakness is more noticeable in the respiratory muscles than in the peripheral muscles, although the latter muscles are also inactive.After coronary artery bypass graft (CABG) surgery, Postoperative pulmonary complications [PPCs] are a major source of morbidity and mortality, and increase length of hospital stay and resource utilization. Post operative inspiratory muscle training (IMT) efficacy in reducing the incidence of PPCs in high-risk patients undergoing CABG surgery has not yet been determined. Therefore, the present study is to determine the efficacy of Powerbreathe medic plus device on maximal inspiratory pressure, functional capacity and quality of life in Coronary Artery Bypass Graft Patients. |