| CTRI Number |
CTRI/2026/01/100034 [Registered on: 01/01/2026] Trial Registered Prospectively |
| Last Modified On: |
30/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
PREVALENCE STUDY |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study in participants after cardiac surgery to identify how muscle activity influences blood pressure and heart rate |
|
Scientific Title of Study
|
Prevalence of Altered Muscle Metaboreflex among patients after cardiac surgeries |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Reeba Sunil Chettupalli |
| Designation |
Post-graduate student |
| Affiliation |
Sri Ramachandra Institute of Higher education and Research |
| Address |
Department of cardiopulmonary sciences,Sri Ramachandra faculty of physiotherapy,Sri Ramachandra Institute of higher education and research,Porur
Chennai.
Chennai TAMIL NADU 600116 India |
| Phone |
8328121428 |
| Fax |
091-44-24765995 |
| Email |
reebachettupalli12@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Mr Ajith Kumar P |
| Designation |
LECTURER |
| Affiliation |
Sri Ramachandra Institute of Higher education and Research |
| Address |
Department of cardiopulmonary sciences,Sri Ramachandra faculty of physiotherapy,Sri Ramachandra Institute of higher education and research,Porur
Chennai.
Chennai TAMIL NADU 600116 India |
| Phone |
9087350257 |
| Fax |
091-44-24765995 |
| Email |
ajithkumarp@sriramachandra.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Mr Ajith Kumar P |
| Designation |
LECTURER |
| Affiliation |
Sri Ramachandra Institute of Higher education and Research |
| Address |
Department of cardiopulmonary sciences,Sri Ramachandra faculty of physiotherapy,Sri Ramachandra Institute of higher education and research,Porur
Chennai.
Chennai TAMIL NADU 600116 India |
| Phone |
9087350257 |
| Fax |
091-44-24765995 |
| Email |
ajithkumarp@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Reeba Sunil Chettupalli |
| Address |
NNo.1, Sri ramachandra nagar,Sri ramachandra faculty of physiotherapy,SRIHER,porur,600116 |
| Type of Sponsor |
Other [Selfunded] |
|
|
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 |
| Reeba Sunil Chettupalli |
Sri Ramachandra Medical centre |
Department of cardithoracic and vascular surgery,SRIHER,
poruru,
600116
Chennai TAMIL NADU |
8328121428
reebachettupalli12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutinal Ethics comimttee,SRIHER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I70-I79||Diseases of arteries, arterioles and capillaries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged 40-65years
Underwent cardiac surgeries (CABG, valve replacement)
Hemodynamically stable
|
|
| ExclusionCriteria |
| Details |
Uncontrolled hypertension or arrhythmias.
Peripheral neuropathy
Peripheral arterial disease and peripheral venous disease
Musculoskeletal impairments,including fractures, myositis ossificans,bone diseases/carcinomas.
Neurological deficits and cognitive impairments.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| altereation of muscle metaboreflex response by blood pressure changes during post-exercise muscle ischemia. |
after surgery 15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Heart rate variability indices, heart rate response, & magnitude of blood pressure changes during metaboreflex activation. |
after surgery 15th day |
|
|
Target Sample Size
|
Total Sample Size="43" Sample Size from India="43"
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)
|
15/01/2026 |
| 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="5" Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Coronary artery bypass grafting (CABG) is a commonly performed cardiac surgery that improves survival and quality of life in patients with coronary artery disease; however, many patients experience delayed functional recovery, reduced exercise tolerance, and altered cardiovascular responses during physical activity after surgery. These limitations are often linked to autonomic nervous system dysfunction, particularly impairment of the muscle metaboreflex, a key reflex that helps maintain arterial blood pressure and muscle perfusion during exercise by increasing sympathetic activity in response to metabolite accumulation in working muscles. Altered metaboreflex function may result in abnormal heart rate and blood pressure responses, reduced heart rate variability, and early fatigue during exertion, thereby affecting rehabilitation outcomes. The muscle metaboreflex is commonly assessed using post-exercise muscle ischemia, where blood flow to the exercised limb is temporarily occluded with a pneumatic cuff to trap metabolites and isolate the reflex response, while cardiovascular parameters are monitored. Despite the high number of CABG procedures performed in India, data on the prevalence of altered muscle metaboreflex in post-CABG patients remain limited. This study aims to determine its prevalence to support individualized physiotherapy and optimize cardiac rehabilitation strategies. |