| 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
|
|
|
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
|
|
|
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. |