| CTRI Number |
CTRI/2025/09/093961 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
01/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effectiveness of Buerger- Allen exercise |
|
Scientific Title of Study
|
A study on effectiveness of
Buerger- Allen exercise in improving circulation and cardiovascular fitness in
coronary artery bypass graft (CABG) patients with diabetes |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhoomika D |
| Designation |
PG Resident |
| Affiliation |
College of Physiotherapy, Sri Ramakrishna Institute Of Paramedical Sciences |
| Address |
3rd Floor, 2nd Room, College Of Physiotherapy ,Sri Ramakrishna Institute Of Paramedical Sciences, 395,Sarojini Naidu road, Sidhapudur, Coimbatore
Coimbatore
TAMIL NADU
641044
India |
| Phone |
7339003269 |
| Fax |
|
| Email |
bhoomikadurairaj2002@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
C H Anand Chellappa |
| Designation |
Professor |
| Affiliation |
College Of Physiotherapy, Sri Ramakrishna Institute Of Paramedical Science |
| Address |
3rd Floor, 2nd Room, College Of Physiotherapy, Sri Ramakrishna Institute Of Paramedical Sciences, 395,Sarojini Naidu road, Sidhapudur, Coimbatore
Coimbatore
TAMIL NADU
641044
India |
| Phone |
9629733374 |
| Fax |
|
| Email |
anandreena2016@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
C H Anand Chellappa |
| Designation |
Professor |
| Affiliation |
College of Physiotherapy, Sri Ramakrishna Institute Of Paramedical Sciences |
| Address |
3rd Floor, 2nd Room, College Of Physiotherapy, Sri Ramakrishna Institute Of Paramedical Sciences, 395,Sarojini Naidu road, Sidhapudur, Coimbatore
Coimbatore
TAMIL NADU
641044
India |
| Phone |
9629733374 |
| Fax |
|
| Email |
anandreena2016@gmail.com |
|
|
Source of Monetary or Material Support
|
| College of Physiotherapy, Sri Ramakrishna Institute Of Paramedical Sciences, coimbatore, Tamil Nadu, India, postal code-641044 |
|
|
Primary Sponsor
|
| Name |
Bhoomika D |
| Address |
3rd Floor, 2nd Room, College Of Physiotherapy , Sri Ramakrishna Institute Of Paramedical Sciences, 395,Sarojini Naidu road, Sidhapudur, Coimbatore-641044 |
| 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 |
| C H Anand Chellappa |
Sri Ramakrishna Multi Speciality Hospital |
Department Of cardiology,Sri Ramakrishna Multi Speciality Hospital, 395,Sarojini Naidu road, Sidhapudur, Coimbatore-641044
Coimbatore
TAMIL NADU |
9629733374
anandreena2016@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Ramakrishna Hospital Ethical committee |
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 |
Buerger Allen Exercises |
Buerger Allen Exercises with Routine care
One person it takes around 2 weeks period |
| Intervention |
Routine Care |
General Physio Care
One person it takes around 2 weeks period |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Patients with type2 diabetes mellitus who undergone CABG post operative (after 1 week) and medically stable, Patients with mild to moderate peripheral arterial insufficiency(ABI-0.5-0.9), Patients who are stable to perform buerger-Allen exercises, Patients with stable vital signs, Patients who are willing to participate |
|
| ExclusionCriteria |
| Details |
Severe Peripheral Arterial Disease Patients with lower ABI lesser than 0.5(indicating critical limb ischemia),Diabetic neuropathy (with loss of protective sensation), Uncontrolled diabetes HbA1c greater than 10 percentage, Unstable Cardiovascular Condition – Ejection fraction less than 50 percentage, Heart failure, Severe Postoperative complications (DVT, Excessive bleeding), Unstable hemodynamic(requiring inotropic support), CABG with three vessel diseases , Other musculoskeletal, Neurological disorders, Psychiatric disorders, Other Medical Conditions Affecting Participation Chronic kidney disease stage 4 or 5 (on dialysis), Severe respiratory disease (with oxygen dependency), Any active infection or fever, Refusal to Participate -Patients who do not provide informed consent or are unwilling to follow the exercise regime
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Ankle Brachial Index
2.Modified Harvard Step Up Test |
6 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/09/2025 |
| Date of Study Completion (India) |
26/11/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
ABSTRACT
The Burgers-Allen exercise, a form of controlled physical activity that aims to improve circulation and promote muscle strength, has been proposed as a beneficial rehabilitation method for patients undergoing coronary artery bypass graft (CABG) surgery, particularly those with comorbid conditions like diabetes. Diabetes mellitus is a prevalent comorbidity in CABG patients, contributing to delayed recovery and increased postoperative complications. This study explores the potential impact of the Burgers-Allen exercise in enhancing post-CABG recovery in diabetic patients, focusing on cardiovascular function, glycemic control, and overall quality of life. A group of diabetic CABG patients were subjected to a structured program of Burgers-Allen exercises post-surgery, with outcomes measured by using ABI and Modified Harvard Step Up Test . Results demonstrated significant improvements in circulation and physical activity levels. This abstract highlights the promise of incorporating Burgers-Allen exercise into postoperative rehabilitation programs for CABG patients with diabetes, suggesting potential benefits in terms of improved clinical outcomes and better quality of life for this patient group. Further research is recommended to solidify the long-term benefits and safety of this intervention. |