| 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
|
|
|
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
|
|
|
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. |