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CTRI Number  CTRI/2025/07/090682 [Registered on: 10/07/2025] Trial Registered Prospectively
Last Modified On: 10/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Walking and Energy Use in People with High Blood Pressure 
Scientific Title of Study   Physiological Cost Index During Walking In Individuals With Hypertension. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jain Mili Mahavir 
Designation  Postgraduate Student 
Affiliation  SDM College Of Physiotherapy  
Address  OPD no 13, Department of Cardio-respiratory disorders, SDM College Of Physiotherapy, Manjushree nagar, Sattur, Dharwad, Karnataka 580009, India
OPD no 13, Department of Cardio-respiratory disorders, SDM College Of Physiotherapy, Manjushree nagar, Sattur, Dharwad, Karnataka 580009, India
Dharwad
KARNATAKA
580009
India 
Phone  8080912021  
Fax    
Email  milijainmk13@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Jain Mili Mahavir 
Designation  Postgraduate student 
Affiliation  SDM college of Physiotherapy  
Address  Opd no-13, Department of cardiorespiratory disorders, sdm college of Physiotherapy, manjushree nagar , sattur, dharwad-580009
Opd no-13, Department of cardiorespiratory disorders, sdm college of Physiotherapy, manjushree nagar , sattur, dharwad-580009
Dharwad
KARNATAKA
580009
India 
Phone  8080912021  
Fax    
Email  milijainmk13@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sangeeta Appannavar 
Designation  Associate Professor And PG Guide 
Affiliation  SDM College Of Physiotherapy  
Address  OPD no 13, Department of Cardio-respiratory disorders, SDM College Of Physiotherapy, Manjushree nagar, Sattur, Dharwad, Karnataka 580009, India
OPD no 13, Department of Cardio-respiratory disorders, SDM College Of Physiotherapy, Manjushree nagar, Sattur, Dharwad, Karnataka 580009, India
Dharwad
KARNATAKA
580009
India 
Phone  9591753487  
Fax    
Email  sangeeta.appannavar@sdmuniversity.edu.in  
 
Source of Monetary or Material Support  
SDM College Of Physiotherapy Manjushree Nagar, Sattur, Dharwad-580009, Karnataka, India. 
 
Primary Sponsor  
Name  Jain Mili Mahavir 
Address  SDM college of Physiotherapy, manjushree nagar, sattur, dharwad-580009 
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 
Jain Mili Mahavir  SDM College Of Physiotherapy   OPD no 13, Department of Cardio-respiratory disorders, SDM College Of Physiotherapy, Manjushree nagar, Sattur, Dharwad, Karnataka 580009, India OPD no 13, Department of Cardio-respiratory disorders, SDM College Of Physiotherapy, Manjushree nagar, Sattur, Dharwad, Karnataka 580009, India
Dharwad
KARNATAKA 		 8080912021

milijainmk13@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC-SDM MEDICAL COLLEGE OF SCIENCES AND HOSPITAL   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I10||Essential (primary) hypertension,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Age 40 to 60 Years
Both Genders.
Individuals diagnosed with hypertension by the physician over a period of one year.
Individuals only on Anti-hypertensive medications.
Individuals whose blood pressure is stable and controlled, ideally through medication.
Individuals who have the Ability to perform the 6MWT (without severe limitations or comorbid conditions preventing physical activity) 
 
ExclusionCriteria 
Details  Individuals on other medications rather than or along with anti-hypertensive like Beta-blocker
or anticoagulants.
Individuals who are psychologically unstable and on medications.
In the past week there should be no fluctuations in the blood pressure.
Individuals with secondary complications like end organ damage.
Individuals with any orthopaedic or neurological problem which may affect walking.
Individuals should not have had recent surgery, acute illnesses, or conditions that might affect cardiovascular function.
Individuals with other major cardiovascular conditions (e.g., coronary artery disease, heart failure) or severe comorbidities (e.g., uncontrolled diabetes, chronic obstructive pulmonary disease.
If an individual is pregnant, as pregnancy can affect cardiovascular physiology, which could alter PCI measurement and participant safety. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To obtain the Physiological Cost Index during the 6-Minute Walk Test in hypertensive individuals.  outcome measures are taken after completion of 6 Minute walk test. 
 
Secondary Outcome  
Outcome  TimePoints 
To obtain the rating of perceived exertion in hypertensive individuals during the 6-Minute Walk Test.  Scale is taken after completion of 6 Minute walk test. 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   16/09/2025 
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 Yet Recruiting 
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  

Individuals diagnosed with hypertension over a period of 1 year will be screened for inclusion and exclusion criteria and patients who meet the inclusion criteria will be recruited after providing informed consent. Demographic details and baseline vitals (heart rate, blood pressure, SpO,) will be recorded. Participants will then perform a 6-minute walk test (6MWT), during which outcome measures will be assessed pre-, during, and post-test. Total distance walked and perceived exertion (Borg scale) will also be noted. The Physiological Cost Index (PCI) will be calculated using the MacGregor’s Formula.

 
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