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CTRI Number  CTRI/2025/12/099744 [Registered on: 23/12/2025] Trial Registered Prospectively
Last Modified On: 22/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Understanding How Pneumonia Affects the Energy Used While Walking 
Scientific Title of Study   Influence of Pneumonia on the Physiological Cost Index (PCI) of 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  Sanjana B Hubballi 
Designation  Postgraduate student 
Affiliation  SDM College of physiotherapy 
Address  OPD number 13 Cardiorespiratory disorders Department SDM College of Physiotherapy SDM College of Medical Sciences and Hospital Manjushree Nagar Sattur Dharwad Dharwad KARNATAKA 580009 india

Dharwad
KARNATAKA
580009
India 
Phone  9481964155  
Fax    
Email  sanjanaguddu69@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Sanjana B Hubballi 
Designation  Postgraduate student 
Affiliation  SDM College of physiotherapy 
Address  OPD number 13 Cardiorespiratory disorders Department SDM College of Physiotherapy SDM College of Medical Sciences and Hospital Manjushree Nagar Sattur Dharwad Dharwad KARNATAKA 580009 india

Dharwad
KARNATAKA
580009
India 
Phone  9481964155  
Fax    
Email  sanjanaguddu69@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sangeeta Appannavar 
Designation  Associate Proffesor 
Affiliation  SDM College of physiotherapy 
Address  OPD number 13 Cardiorespiratory disorders Department SDM College of Physiotherapy SDM College of Medical Sciences and Hospital Manjushree Nagar Sattur Dharwad 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, SDM College of Medical Sciences and Hospital, Manjushree Nagar, Sattur, Dharwad, Dharwa, Karnataka 580009 India  
 
Primary Sponsor  
Name  Dr Sanjana B Hubballi 
Address  OPD number 13 Cardiorespiratory Department SDM College of Physiotherapy SDM College of Medical Sciences and Hospital Manjushree Nagar Sattur Dharwad Dharwad KARNATAKA 580009 India 
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 Sanjana B Hubballi  Shri Dharmasthala Manjunatheshwara hospital Manjushree Nagar Sattur Dharwad Karnataka 580009   OPD number 13 Cardiorespiratory Department SDM College of Physiotherapy SDM College of Medical Sciences and Hospital Manjushree Nagar Sattur Dharwad KARNATAKA 580009 India
Dharwad
KARNATAKA 
09481964155

sanjanaguddu69@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC-SDM college of medical science  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J00-J99||Diseases of the respiratory system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Age 40-70 years. 2.Confirmed diagnosis of pneumonia by clinical, radiological or microbiological confirmation. 3. Hemodynamically stable with no active shock or unstable vitals. 4.Able to ambulate independently with or without assistive devices. 5.Resting SpO2 greater than or equal to 88percent on room air or supplemental oxygen. 6.Medically cleared for physical activity. 
 
ExclusionCriteria 
Details  1.Unstable cardiovascular conditions
2.Uncontrolled hypertension,
arrhythmias, recent myocardial
infarction
3.Severe orthopedic or neuromuscular
limitations that impair walking
4.Cognitive impairment that interferes
With understanding instructions
5.Pregnancy
6.Use of beta-blockers or medications
that significantly blunt heart rate
response
7.Ongoing fever greater than or equal to 38.5°C at the time of
testing (pneumonia group)
8.History of chronic respiratory disease
(e.g., COPD, asthma) in control
group
9.Inability or refusal to give informed
consent. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
physiological cost index  outcome measures are taken after completion of the 6-minute walk test 
 
Secondary Outcome  
Outcome  TimePoints 
Borgs rate of perceived exertion  Scale is taken after completion of Minutes walk 
 
Target Sample Size   Total Sample Size="63"
Sample Size from India="63" 
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)   01/02/2026 
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 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  

Titled "Influence of Pneumonia on the Physiological Cost Index (PCI) of Walking" investigates how pneumonia impacts energy expenditure during ambulation. Pneumonia, a serious respiratory infection caused by bacteria, viruses, or fungi, leads to inflammation of the alveoli and compromises respiratory efficiency. It remains a major public health issue in India, particularly affecting the elderly and individuals with weakened immune systems. The condition often results in reduced exercise tolerance, fatigue, and impaired functional mobility. While conventional tools such as spirometry are effective for assessing lung function, their reliance on specialized equipment and trained personnel makes them less feasible in resource-limited settings. The Physiological Cost Index (PCI), a simple and non-invasive method, offers an alternative by estimating energy expenditure through heart rate changes in relation to walking speed. This cross-sectional study will recruit adults aged 40–70 years with clinically diagnosed pneumonia who are medically stable and able to walk independently. Participants will undergo a 6-minute walk test (6MWT) during which key physiological parameters heart rate, respiratory rate, oxygen saturation, and blood pressure, will be measured pre- and post-test. PCI will be calculated using MacGregor’s formula: (Post-walking Heart Rate – Resting Heart Rate) / Speed (m/min). Additional outcome measures include the Borg Scale for perceived exertion, CURB-65 pneumonia severity score, Fatigue Severity Scale (FSS), and other clinical markers. Individuals with unstable cardiovascular conditions, neuromuscular impairments, ongoing fever, or chronic respiratory disorders will be excluded. This study is distinctive in applying PCI to pneumonia patients—a population not commonly assessed for ambulatory energy cost. It aims to reveal elevated PCI values in this group, reflecting the increased physiological demand associated with pneumonia. The findings are expected to guide physiotherapists in developing tailored rehabilitation programs based on functional limitations. Moreover, it supports the integration of PCI into routine physiotherapy assessments as a cost-effective and accessible tool for tracking functional recovery in both hospital and community settings.

 
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