| CTRI Number |
CTRI/2025/09/095309 [Registered on: 23/09/2025] Trial Registered Prospectively |
| Last Modified On: |
22/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effects of Pranayama on respiratory functions and exercise tolerance in burn patients |
|
Scientific Title of Study
|
Effects of Pranayama on Pulmonary Functions and Exercise Tolerance in Chest Burn patients: A Randomized Controlled study |
| 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 Ganesh B R |
| Designation |
Professor |
| Affiliation |
KAHER Institute of physiotherapy Belgavi. |
| Address |
KLE hospital and medical resrach centre,Physiotherapy department OPd no 06. Neharu nagar
Belgavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9844857581 |
| Fax |
|
| Email |
drganeshnssofficer@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ganesh B R |
| Designation |
Professor |
| Affiliation |
KAHER Institute of physiotherapy Belgavi. |
| Address |
KLE hospital and medical resrach centre,Physiotherapy department OPd no 06. Neharu nagar
Belgavi
Belgaum
KARNATAKA
590010
India |
| Phone |
9844857581 |
| Fax |
|
| Email |
drganeshnssofficer@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vaishnavi Jadhav |
| Designation |
student |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
KLE hospital and medical resrach centre,Physiotherapy department OPd no 06. Neharu nagar
Belgavi
Belgaum
KARNATAKA
590010
India |
| Phone |
09096992615 |
| Fax |
|
| Email |
vaishjadhav2621@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
KLE hospital and medical resrach centre,Physiotherapy department OPd no 06. Neharu nagar
Belgavi |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Vaishnavi Jadhav |
kle Hospital belagavi |
KLE hospital Neharu Nagar Belgavi
Belgaum
KARNATAKA |
9096992615
vaishjadhav2621@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: T212||Burn of second degree of trunk, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Coventional breathing exercise |
Group B will perform conventional breathing exercises for the same duration and frequency focusing on diaphragmatic breathing lung expansion and resistancebased techniques |
| Intervention |
Pranayama Breathing Exercise |
The intervention includes two groups over four weeks. Group A will practice pranayama breathing exercises for 30 to 45 minutes, five days a week starting with basic breath awareness and progressing to structured techniques with controlled rhythmic breathing. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with all the gender who are willing to participate in the study
patients have burn injuries assessed using lund browder chart to determine total surface area affected by burn
burn first and second degree affecting various body area with coverage of five percent to twenty five percent of the body. |
|
| ExclusionCriteria |
| Details |
Patients with significant underlying respiratory conditions copd asthma
mechanical ventilator or supplemental oxygen
individual with neurological impairments affecting ability to participate in pranayama or breathing exercise |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pulmonary function test
2 minutes walk test |
Pulmonary function test
2 minutes walk test |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
03/10/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
03/10/2025 |
| 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
|
This research project is a randomized controlled trial designed to evaluate the effect of pranayama on pulmonary function and exercise tolerance in burn patients. Burn injuries, especially those involving the chest, often lead to respiratory complications such as reduced lung expansion, impaired gas exchange, and decreased endurance, which significantly affect recovery and quality of life. Pranayama, a yogic breathing practice, has been shown to enhance lung capacity, strengthen respiratory muscles, and promote relaxation in individuals with chronic respiratory conditions, yet its role in burn rehabilitation remains underexplored. In this study, 36 adult participants with 1st and 2nd degree burns involving 5–25% of body surface area will be randomly allocated into two groups: one practicing pranayama breathing exercises and the other performing conventional breathing exercises, each for 30–45 minutes per session, five days a week for four weeks. Pulmonary function tests (FEV1, FVC, PEFR) and the 2-Minute Walk Test (2MWT) will be used as outcome measures before and after intervention. The findings are expected to determine whether pranayama provides additional benefits over conventional rehabilitation in improving respiratory function, physical endurance, and overall quality of life in burn patients |