| CTRI Number |
CTRI/2024/05/066988 [Registered on: 08/05/2024] Trial Registered Prospectively |
| Last Modified On: |
07/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
How does pre surgery physical activity affect lung function and complications after heart bypass surgery. |
|
Scientific Title of Study
|
Association between preoperative physical activity on pulmonary function and post pulmonary complications in patients undergone CABG surgery - Cohort 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 |
Pallavi Gunvant Mane |
| Designation |
Cardiovascular and respiratory physiotherapy Post graduate Resident |
| Affiliation |
Sancheti Institute for Orthopedics and Rehabilitation College of Physiotherapy |
| Address |
1st floor,Sancheti Institute for Orthopaedics and Rehabilitation , College of Physiotherapy.11/12 Thube Park, Shivajinagar ,Pune
Pune
MAHARASHTRA
411005
India |
| Phone |
7745895779 |
| Fax |
|
| Email |
pgmane99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jahnvi Panwar |
| Designation |
Associate Professor |
| Affiliation |
Sancheti Institute for Orthopedics And Rehabilitation College Of Physiotherapy |
| Address |
1st floor,Sancheti Institute for Orthopedics and rehabilitation, college of Physiotherapy.11/12 Thube park, Shivajinagar , Pune
Pune
MAHARASHTRA
411005
India |
| Phone |
9396604972 |
| Fax |
|
| Email |
Jahnvip4@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pallavi Mane |
| Designation |
Cardiovascular and respiratory physiotherapy Post graduate resident |
| Affiliation |
Sancheti Institute of Orthopaedic and rehabilitation college of physiotherapy |
| Address |
1st floor,Sancheti Institute for Orthopedics and rehabilitation, college of Physiotherapy.11/12 Thube park, Shivajinagar , Pune 411005
Sancheti Institute for Orthopedics and rehabilitation, college of Physiotherapy.11/12 Thube park, Shivajinagar , Pune
Pune
MAHARASHTRA
411005
India |
| Phone |
07745895779 |
| Fax |
|
| Email |
pgmane99@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sancheti Institute for Orthopedics and rehabilitation college of physiotherapy 11/12 Thube park shivajinagar ,pune-411005 |
|
|
Primary Sponsor
|
| Name |
Pallavi Mane |
| Address |
Sancheti Institute for Orthopedics and rehabilitation College of Physiotherapy 11/12 Thube park shivajinagar Pune Maharashtra 411005 ,India |
| Type of Sponsor |
Other [] |
|
|
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 Pallavi mane |
Sancheti Institute for Orthopedic and rehabilitation college of physiotherapy |
1st floor,Sancheti institute for orthopedic and rehabilitation college of physiotherapy Thube park , shivajinagar Pune- 411005
Pune
MAHARASHTRA |
07745895779
pgmane99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sancheti Institute for Orthopedics and Rehabilitation College Of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I778||Other specified disorders of arteries and arterioles, (2) ICD-10 Condition: I778||Other specified disorders of arteries and arterioles, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients who have undergoing CABG surgery
2) Able to perform basic physical activity
3) Patients with known pulmonary diseases |
|
| ExclusionCriteria |
| Details |
1) Patients who have undergone previous CABG surgery
2) Patients who are Unable to perform basic physical activity |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.International physical activity questionnaire (IPAQ)
2. Kroenke post pulmonary complication scale
3.Pulmonary function test (slow vital capacity) |
Before 1day of surgery and after Postoperative day 5th |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.slow vital capacity |
Before 1 day of surger and 5th day of surgery |
|
|
Target Sample Size
|
Total Sample Size="81"
Sample Size from India="81"
Final Enrollment numbers achieved (Total)= "81"
Final Enrollment numbers achieved (India)="81" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/05/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Worldwide approximately 2 million heart surgeries done, Although CABG surgery is an effective coronary revascularization technique associated with decrease pulmonary function. Also post pulmonary complications are the main cause of morbidity and mortality in patients undergoing CABG surgery which prolong intensive care unit stay .So this study determine how patients physical activity prior to surgery can impact on respiratory function and development post pulmonary complications also identify whether increased physical activity prior to surgery corelates with better pulmonary function and reduced post pulmonary complications.
Null hypothesis - There will be no significant association between preoperative physical activity on pulmonary function and post pulmonary complications anong individuals under hone CABG survey. Alternate hypothesis - There will be significant association between preoperative physical activity on pulmonary function and post pulmonary complications among patients undergone CABG surgery. |