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CTRI Number  CTRI/2024/07/071681 [Registered on: 31/07/2024] Trial Registered Prospectively
Last Modified On: 16/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Health Monitoring While performing daily activities like Running, Walking, sitting and other Daily Tasks 
Scientific Title of Study   Collection of physiological parameters of subjects during different daily activities such as running, walking 
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 Subramani Kanagaraj 
Designation  Professor 
Affiliation  Indian Institute of Technology Guwahati 
Address  Biomedical Devices and Biomaterials Laboratory, Department of Mechanical Engineering, Indian institute of Technology Guwahati

Kamrup
ASSAM
781039
India 
Phone  03612582676  
Fax    
Email  kanagaraj@iitg.ac.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Subramani Kanagaraj 
Designation  Professor 
Affiliation  Indian Institute of Technology Guwahati 
Address  Biomedical Devices and Biomaterials Laboratory, Department of Mechanical Engineering, Indian institute of Technology Guwahati

Kamrup
ASSAM
781039
India 
Phone  03612582676  
Fax    
Email  kanagaraj@iitg.ac.in  
 
Details of Contact Person
Public Query  
Name  Subhojit Jash 
Designation  Research Scholar 
Affiliation  Indian institute of Technology Guwahati 
Address  Biomedical Devices and Biomaterials Laboratory, Department of Mechanical Engineering, Indian institute of Technology Guwahati

Kamrup
ASSAM
781039
India 
Phone  03612582676  
Fax    
Email  subhojit.jash@iitg.ac.in  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Subramani Kanagaraj 
Address  Biomedical Device and Biomaterials Laboratory, Indian Institute of Technology Guwahati Assam, India Pin: 781039 
Type of Sponsor  Other [Self] 
 
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 Subramani Kanagaraj  Indian Institute of Technology Guwahati  Gait and motion analysis lab, first floor, Research building, Indian Institute of Technology Guwahati Kamrup ASSAM
Kamrup
ASSAM 		 03612582676

kanagaraj@iitg.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Human Ethical Committee Indian Institute of Technology Guwahati  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  The participant should be mentally and physically healthy and must be able to read and understand English, Hindi, Assamese or any other Indian language and demonstrate the ability and willingness to follow the protocol. 
 
ExclusionCriteria 
Details  1.Unable to follow the instruction or cognitive deficits
2.Risk of further injury whilst completing tasks incorrectly
3.Unable to perform tasks due to current medical conditions
4.Subjects with active infection are not included
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.To develop an Indian database of raw Photoplethysmograph (PPG) signal of Healthy participants during resting, walking, and running.
2. To develop an Indian database of the Heart rate, Respiratory Rate and SpO2 of Healthy participants during resting, walking, and running. 		 Activities are performed at interval of 2 days 
 
Secondary Outcome  
Outcome  TimePoints 
1.To study signal features to characterize participants during resting, walking, running.
 		 Activities are performed at interval of 2 days 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   20/08/2024 
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="3"
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  

Healthy monitoring has become an essential part of our daily lifestyle. Current monitoring systems utilize Photoplethysmograph (PPG) and Electrocardiogram (ECG) signals to detect heart rate and SpO2 levels. However, accurately monitoring respiratory rate during daily activities, particularly those involving high respiratory rates like running, requires more in-depth analysis. The current literature does not provide precise analysis for measuring various health parameters. This study aims to create a database of raw PPG signals specifically for the Indian population and utilize these signals to monitor different health conditions. Accurately tracking all these parameters is crucial for improving overall health quality. This comprehensive approach not only enhances our understanding of how different activities affect our bodies but also aids in developing personalized health and fitness plans. Additionally, the study will help bridge the gap in existing research by providing accurate data and analysis, leading to better health monitoring solutions tailored to individual needs. This can significantly contribute to more effective health management and improved lifestyle choices.

 
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