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CTRI Number  CTRI/2025/09/095258 [Registered on: 22/09/2025] Trial Registered Prospectively
Last Modified On: 20/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of Breathing Exercises on Breathing Ability and Quality of Life in COPD 
Scientific Title of Study   Breathing Techniques in COPD: A Comparison of Papworth Breathing and Box Breathing – A Randomized Clinical Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anushka Kulkarni  
Designation  Postgraduate Student (MPT in CVTS Physiotherapy) 
Affiliation  KAHER Institute of Physiotherapy 
Address  Sagar floor,Adavanced physiotherapy Center room No 39 Dr Prabhakar kore Hospital and MRC, Nehru Nagar, Belagavi Belgaum

Belgaum
KARNATAKA
590010
India 
Phone  9922082216  
Fax    
Email  anushkakulkarni20302@gmail.com   
 
Details of Contact Person
Scientific Query  
Name  Dr Varun Naik 
Designation  MPT PhD Associate Professor, Department of cardiovascular and pulmonary physiotherapy, 
Affiliation  KAHER Institute of Physiotherapy 
Address  Sagar floor,Adavanced physiotherapy Center room No 39 Dr Prabhakar kore Hospital and MRC, Nehru Nagar, Belagavi Belgaum

Belgaum
KARNATAKA
590010
India 
Phone  9986497065  
Fax    
Email  varunnaik@klekipt.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Varun Naik 
Designation  MPT PhD Associate Professor, Department of cardiovascular and pulmonary physiotherapy, 
Affiliation  KAHER Institute of Physiotherapy 
Address  Sagar floor,Adavanced physiotherapy Center room No 39 Dr Prabhakar kore Hospital and MRC, Nehru Nagar, Belagavi Belgaum

Belgaum
KARNATAKA
590010
India 
Phone  9986497065  
Fax    
Email  varunnaik@klekipt.edu.in  
 
Source of Monetary or Material Support  
KAHER Institute of Physiotherapy, Nehru Nagar, belgaum, 590010 karnataka  
 
Primary Sponsor  
Name  KLE institute of physiotherapy 
Address  Nehru nagar , belgaum 590010 karnataka  
Type of Sponsor  Private 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 Varun Naik  KLE Prabhakar Kores Hospital  Sagar floor, Advanced physiotherapy Center room No 39 Dr Prabhakar kore Hospital and MRC, Nehru Nagar, Belagavi
Belgaum
KARNATAKA 		 9986497065

varunnaik@klekipt.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KAHER institute of physiotherapy   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  box breathing technique  Mode: structured yogic breathing with equal inhalation hold exhalation and then hold. pattern- inhale 4 secs then hold 4 secs and then again exhale 4 secs and hold for 4 secs . Frequency & Duration: 2 sessions per day × 5 days 15–20 minutes per session Along with: Conventional physiotherapy:that includes nebulization, postural drainage (percussion, vibration, huffing, coughing), thoracic expansion exercises And pursed lip breathing 
Comparator Agent  Papworth breathing technique   Mode: Breathing retraining with relaxation Components: Diaphragmatic breathing Nasal breathing (inhale/exhale through nose) Controlled breathing paced with activity Relaxation techniques (focus on abdominal and chest movements) Integration into daily activities Frequency & Duration: 2 sessions per day × 5 days 15–20 minutes per session Along with: Conventional physiotherapy: nebulization, postural drainage (percussion, vibration, huffing, coughing), thoracic expansion exercises And pursed lip breathing  
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  atients of either gender aged between 30 and 65 years with a confirmed diagnosis of chronic obstructive pulmonary disease (COPD) will be included in the study. Eligible participants must have a post-bronchodilator FEV1/FVC ratio of less than 0.70 and a forced expiratory volume in one second (FEV1) less than or equal to 80 percent. Only those subjects who are willing to participate voluntarily and provide informed consent will be enrolled. 
 
ExclusionCriteria 
Details  Patients will be excluded if they present with severe respiratory distress requiring emergency interventions or if they are hemodynamically unstable. Individuals with recent trauma such as rib fractures, head and neck injuries, or spinal cord injuries will not be considered. Patients with active haemoptysis, untreated pneumothorax, or pulmonary edema will also be excluded. Similarly, those who have undergone recent spinal surgeries, or who have neurological disorders that may affect their ability to perform breathing exercises, will not be included. In addition, patients diagnosed with cardiac conditions such as recent myocardial infarction or arrhythmias will be excluded from the study 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Peak Expiratory Flow Rate (PEFR):and FEV1 and FVC measured using a digital peak flow meter to assess lung function.
2.Health-related Quality of Life: assessed using the St. George’s Respiratory Questionnaire for COPD (SGRQ-C)
3.Dyspnea Severity: measured using the Modified Borg Scale (CR-10) at rest and after activity. 		 at the baseline, that is pre-intervention and after 5 days of intervention  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL
 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
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 2 
Date of First Enrollment (India)   01/10/2025 
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="0"
Months="9"
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   Chronic obstructive pulmonary disease (COPD) is a progressive lung condition that causes airflow limitation, dyspnea, cough and reduced quality of life. Non-pharmacological interventions such as breathing techniques are increasingly used as adjuncts to medical management. The present randomized clinical trial aims to determine and compare the effects of Papworth breathing and Box breathing on respiratory function and health related quality of life in patients with COPD. Forty-two participants aged 30 to 65 years with confirmed diagnosis of COPD will be randomly allocated into two groups. Group A will receive Papworth breathing with conventional chest physiotherapy and Group B will receive Box breathing with conventional chest physiotherapy. Each intervention will be given twice daily for five days. Outcome measures include Peak Expiratory Flow Rate, St. George Respiratory Questionnaire and Modified Borg Scale. The findings may provide evidence on the role of structured breathing exercises in improving symptoms and quality of life in COPD patients. 
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