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CTRI Number  CTRI/2024/09/073615 [Registered on: 09/09/2024] Trial Registered Prospectively
Last Modified On: 23/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   changes in cardiopulmonary function upon doing physical activity. 
Scientific Title of Study   Response to Cardiopulmonary Exercise Testing among different levels of physically active adults and its correlation with Body Composition. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nayan Mani Barman 
Designation  Postgraduate, Junior resident 
Affiliation  All India Institute of Medical Science Guwahati 
Address  Dept of Physiology, AIIMS Guwahati, Changsari, Kamrup, Assam

Kamrup
ASSAM
781101
India 
Phone  07002766848  
Fax    
Email  maninayanbarman0@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Manasi Bhattacharjee 
Designation  Professor & Head of the Department Physiology 
Affiliation  All India Institute of Medical Science Guwahati 
Address  Dept of Physiology, AIIMS Guwahati, Changsari, Kamrup, Assam

Kamrup
ASSAM
781101
India 
Phone  9716103379  
Fax    
Email  manasibhattacharjee@aiimsguwahati.ac.in  
 
Details of Contact Person
Public Query  
Name  Nayan Mani Barman 
Designation  Postgraduate, Junior resident 
Affiliation  All India Institute of Medical Science Guwahati 
Address  Dept of Physiology, AIIMS Guwahati, Changsari, Kamrup, Assam

Kamrup
ASSAM
781101
India 
Phone  07002766848  
Fax    
Email  maninayanbarman0@gmail.com  
 
Source of Monetary or Material Support  
Department of physiology, AIIMS Guwahati, Changsari, Kamrup, Assam, India Pin code: 781101 
 
Primary Sponsor  
Name  Department of Physiology AIIMS Guwahati 
Address  Department of physiology, AIIMS Guwahati, Changsari, Kamrup, Assam, India Pin code: 781101 
Type of Sponsor  Government medical college 
 
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 Nayan Mani Barman  All India Institute of Medical Sciences, Guwahati  Room No. A126, Exercise Physiology lab, Department of Physiology, 1st floor, medical college building, AIIMS Guwahati, Assam
Kamrup
ASSAM 		 07002766848

maninayanbarman0@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Guwahati  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  apparently healthy individual with different grade of physical activity. 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  Adult males and females between 18 to 35 years of age. 
 
ExclusionCriteria 
Details  a. Persons diagnosed with hypertension.
b. Persons diagnosed with any cardiac abnormality.
c. Inability to perform spirometry.
d. Persons with recent history (within past 6 months) of major trauma or surgery.
e. Persons with family history of sudden cardiac death. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The study will provide the insight to explore the relationship between physical activity and cardiopulmonary exercise testing with implication for health, disease prevention and customised exercise prescription. Association between different grades of physical activity and body composition in adults will also be elucidated.  3 years 
 
Secondary Outcome  
Outcome  TimePoints 
Association between different grades of physical activity and body composition in adults will also be elucidated.  3 years 
 
Target Sample Size   Total Sample Size="102"
Sample Size from India="102" 
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)   30/09/2024 
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  
 The research is going to be a single-centre, cross-sectional, observational study at the Department of Physiology, AIIMS Guwahati for two and a half years, on eligible participants of age 18 to 35 years recruited from AIIMS OPD visitor, staff and students of the institution. The instruments required for the study are stadiometer, BP apparatus, pulse oximeter, body composition analyser and CPET machine. Participants will be called in the physiology lab. On the first day, the entire procedure will be explained, informed consent taken and the pre-validated, free to use International Physical Activity questionnaire (IPAQ) will be administered to the participants. Based on this each participant will be assigned to a particular group, namely, physically inactive, minimally active or health enhancing physically active group. Their base line blood pressure and ECG will be recorded. Following this, body composition analysis will be conducted and they will be accustomed to the CPET set up. They will be asked to report to the lab on the next day after a light meal in comfortable clothing. Cardiopulmonary exercise testing as per protocol will be performed. All the data will be analysed and the results of three group will be compared and correlated with the body composition data. The study does not involve any intervention or randomization.
 
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