| CTRI Number |
CTRI/2026/01/101978 [Registered on: 23/01/2026] Trial Registered Prospectively |
| Last Modified On: |
22/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A Study of Heart Rate Variability in Sedentary and Physically Active Young Individuals |
|
Scientific Title of Study
|
Comparison of ECG based 5 min Heart Rate Variability (HRV) Between Sedentary and Physically Active Young Individuals |
| 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 Vishvjeetsinh Zala |
| Designation |
PG Resident Doctor |
| Affiliation |
Government Medical College, Bhavnagar |
| Address |
Government Medical College, Bhavnagar Opp. New Library, Gardi Gate, Maharaja Krishnakumarsinhji Bhavnagar University, Bhavnagar 364001, Gujarat, India
Bhavnagar
GUJARAT
364001
India |
| Phone |
7046248073 |
| Fax |
|
| Email |
vishvjeetsinhzala03@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayesh Solanki |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College, Bhavnagar |
| Address |
Government Medical College, Bhavnagar Opp. New Library, Gardi Gate, Maharaja Krishnakumarsinhji Bhavnagar University, Bhavnagar 364001, Gujarat, India
Bhavnagar
GUJARAT
364001
India |
| Phone |
9998361004 |
| Fax |
|
| Email |
drjaymin_83@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayesh Solanki |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College, Bhavnagar |
| Address |
Government Medical College, Bhavnagar Opp. New Library, Gardi Gate, Maharaja Krishnakumarsinhji Bhavnagar University, Bhavnagar 364001, Gujarat, India
Bhavnagar
GUJARAT
364001
India |
| Phone |
9998361004 |
| Fax |
|
| Email |
drjaymin_83@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department Of Physiology, Government Medical College, Bhavnagar Opp. New Library, Gardi Gate, Maharaja Krishnakumarsinhji Bhavnagar University, Bhavnagar 364001 Gujarat, India |
|
|
Primary Sponsor
|
| Name |
Dr Vishvjeetsinh Zala |
| Address |
Government Medical College, Bhavnagar Opp. New Library, Gardi Gate, Maharaja Krishnakumarsinhji Bhavnagar University, Bhavnagar 364001 |
| 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 |
| Dr Vishvjeetsinh Zala |
Excercise Physiology Lab., Government Medical College, Bhavnagar |
23, Excercise Physiology Lab., Department of Physiology,Government Medical College, Bhavnagar Opp. New Library, Gardi Gate, Maharaja Krishnakumarsinhji Bhavnagar University, Bhavnagar 364001 Bhavnagar
Gujarat
Bhavnagar
GUJARAT |
7046248073
vishvjeetsinhzala03@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Government Medical College, Bhavnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
For Physical Active Groups : Physical Activity Minimum 30 min per day or 150 min per week for most of week in a year
For Sedentary Group : Not doing any Physical Activity |
|
| ExclusionCriteria |
| Details |
Addiction or Substance Abuse
Any Recent illness or Disease like Febrile illnesses Acute Myocardial infarction |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| We can see HRV parameters are better with physical activity or in sedentary individuals |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
02/02/2026 |
| 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
|
-To Compare 5 min HRV between sedentary and physically active young individuals -To Compare Resting HRV between Sedentary and physically active (walking, cycling and swimming) -To Compare HRV between physically active groups (walking, cycling and swimming) -A cross sectional study -Duration 10 to 12 months -Sample size 150 subjects -Inclusion criteria Age 18 to 40 years, For physically active groups physical activity minimum 30 min per day or 150 min per week for most of week in a year and for sedentary group Not doing any physical activity -Exclusion criteria Addiction or substance abuse, Any recent illnesses -We will measure and compare Time domain, Frequency domain and Geometric domain HRV parameters in subjects |