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CTRI Number  CTRI/2026/03/107115 [Registered on: 30/03/2026] Trial Registered Prospectively
Last Modified On: 24/03/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   A full assessment of the things that affect how a patients heart rate changes during a treadmill exercise test(TMT) and recovers down afterward 
Scientific Title of Study   A comprehensive assessment of factors influencing heart rate response during exercise stress and subsequent recovery among patients undergoing TMT 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Krishnananda Nayak 
Designation  Professor, HOD 
Affiliation  Manipal College Of Health Professions, MAHE 
Address  Department of Cardiovascular technology, Manipal College Of Health Professions, MAHE

Udupi
KARNATAKA
576104
India 
Phone  9449215487  
Fax    
Email  krishnananda.n@manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Krishnananda Nayak 
Designation  Professor, HOD 
Affiliation  Manipal College Of Health Professions, MAHE 
Address  Department of Cardiovascular technology, Manipal College Of Health Professions, MAHE

Udupi
KARNATAKA
576104
India 
Phone  9449215487  
Fax    
Email  krishnananda.n@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Krishnananda Nayak 
Designation  Professor, HOD 
Affiliation  Manipal College Of Health Professions, MAHE 
Address  Department of Cardiovascular technology, Manipal College Of Health Professions, MAHE

Udupi
KARNATAKA
576104
India 
Phone  9449215487  
Fax    
Email  krishnananda.n@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Medical Collage and Hospital, Manipal, Manipal Academy Of Higher Education, Madhav Nagar, Manipal, Udupi, Karnataka, India - 576104 
 
Primary Sponsor  
Name  Kasturba Medical College Manipal Manipal Academy Of Higher Education 
Address  Kasturba Medical College and Hospital, Tiger circle road, Madhav Nagar, Manipal, Udupi, Karnataka, PIN-576104 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Krishnananda Nayak  Kasturba Hospital  Department Of Cardiology, 3rd Floor, Kasturba Hospital, Tiger Circle Road, Madhava Nagar, Manipal, Pin-576104
Udupi
KARNATAKA 
9449215487

krishnananda.n@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I00-I99||Diseases of the circulatory system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1.Patients undergoing TMT aged above 18 years
2.Male and female participants to allow for gender-based comparisons
3.Participants with common conditions (e.g., obesity, diabetes, controlled hypertension, subclinical thyroid dysfunction) to enable factor analysis.
 
 
ExclusionCriteria 
Details  1.Patients unwilling to give consent for the study

2.Use of medications that significantly alter heart rate


3.Test protocol other than Bruce

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the factors influencing heart rate response during exercise stress test and recovery time post exercise  baseline 
 
Secondary Outcome  
Outcome  TimePoints 
To assess ST-T changes and QT changes associated with heart rate response and BP response with heart rate changes  baseline 
 
Target Sample Size   Total Sample Size="1200"
Sample Size from India="1200" 
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)   10/04/2026 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

The study titled “A Comprehensive Assessment of Factors Influencing Heart Rate Response During Exercise Stress and Subsequent Recovery Among Patients Undergoing TMT” is a prospective cross-sectional study conducted by the Department of Cardiology and the Department of Cardiovascular Technology at Kasturba Medical College , Manipal. The study aims to evaluate the factors influencing heart rate response during exercise stress testing and subsequent recovery among patients undergoing treadmill testing.

The primary objective is to assess the determinants affecting heart rate response during exercise stress and the recovery time following exercise. The secondary objectives are to evaluate ST-segment and QT interval changes associated with heart rate response and to assess blood pressure  response in relation to heart rate variations.

Exercise stress testing using the Treadmill Test  is a widely used non-invasive diagnostic tool for evaluating cardiovascular function and detecting ischemic heart disease. Heart rate behavior during exercise and its recovery phase serve as important indicators of autonomic nervous system function and cardiovascular fitness. Abnormal responses, such as chronotropic incompetence  or delayed heart rate recovery, have been associated with increased cardiovascular morbidity and mortality. Despite this, there is limited literature particularly in the Indian population examining how modifiable risk factors such as smoking, obesity, diabetes, controlled hypertension, and subclinical thyroid dysfunction influence heart rate response and recovery patterns. This study seeks to address this gap.

The study period will be from February 2026 to January 2027. Approximately 90 to 100 patients undergo TMT each month in the Department of Cardiology. As a time-bound study, an estimated 1,200 participants  will be included.Inclusion criteria comprise adults aged above 18 years undergoing TMT using the Bruce protocol. Both male and female participants will be included to allow gender-based comparisons. Patients with common cardiovascular risk factors such as obesity, diabetes, controlled hypertension, and subclinical thyroid dysfunction will be eligible. Exclusion criteria include unwillingness to provide consent, use of medications that significantly alter heart rate , and TMT performed using protocols other than Bruce.

The study will follow a structured clinical workflow. Patients referred for routine TMT and willing to participate will be recruited after obtaining informed consent. Baseline parameters such as heart rate, blood pressure, ECG findings, medical history, occupation, and lifestyle factors will be recorded. During the test, heart rate at each minute of exercise, time taken to reach target heart rate , peak heart rate, maximum blood pressure, maximum workload achieved and time taken for heart rate recovery will be documented. Additional ECG parameters including ST-segment elevation or depression and QT interval changes will be noted. The final TMT result  will also be recorded.

All parameters will be obtained during routine TMT without any additional procedures, drugs, or costs to the patient. The test will be conducted using the GE CASE Treadmill system under cardiologist supervision. In case of emergencies, patients will be managed according to hospital protocol.

Data will be entered into Microsoft Excel and analyzed using Excel and Jamovi software. 

Outcome measures include demographic details like age, gender, occupation, cardiovascular risk factors, baseline heart rate and blood pressure, age-predicted maximum heart rate , target heart rate , heart rate reserve, maximum workload, peak blood pressure, time to reach target heart rate, heart rate recovery time, ST-segment changes, QT interval duration, and overall TMT result.


The study poses minimal risk as it is observational and utilizes routine diagnostic testing. There are no additional interventions beyond standard clinical care. Potential benefits include improved understanding of how modifiable and non-modifiable factors influence heart rate dynamics during exercise. Findings may aid in early identification of abnormal autonomic responses, enhance cardiovascular risk stratification, and support preventive strategies aimed at reducing long-term heart disease, disability, and mortality.


Ethical approval will be obtained from the Institutional Ethics Committee , and CTRI registration will be completed prior to study initiation. Written informed consent will be secured from all participants. Confidentiality of patient data will be strictly maintained, with access limited to authorized personnel. Any presentation or publication arising from the study will not include identifiable patient information.

 
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