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CTRI Number  CTRI/2025/07/091319 [Registered on: 21/07/2025] Trial Registered Prospectively
Last Modified On: 18/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Effect of breathing control vs pursed lip breathing on lung function and quality of life in asthma: A Randomised Trial 
Scientific Title of Study   Compare the effect of breathing control and pursed lip breathing on peak expiratory flow rate, chest expansion and HR QoL in bronchial asthma patients: A randomised controlled 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  Revati Ravindra Tekale 
Designation  Intern 
Affiliation  Dr APJ AK College of Physiotherapy 
Address  503 Department of cardiorespiratory Dr APJ Abdul Kalam College of Physiotherapy pravara institute of medical sciences loni 413736 taluka rahata distric ahamadnagar
503 Department of cardiorespiratory Dr APJ Abdul Kalam College of Physiotherapy pravara institute of medical sciences loni 413736 taluka rahata distric ahamadnagar
Ahmadnagar
MAHARASHTRA
413736
India 
Phone  08010371801  
Fax    
Email  revatitekale15@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Saumi Rakesh Sinha 
Designation  Associate professor  
Affiliation  Dr APJ AK College of Physiotherapy 
Address  503 Department of cardiorespiratory Dr APJ Abdul Kalam College of Physiotherapy pravara institute of medical sciences Loni 413736 taluka Rahata distric Ahmadnagar
503 Department of cardiorespiratory Dr APJ Abdul Kalam College of Physiotherapy pravara institute of medical sciences Loni 413736 taluka Rahata distric Ahmadnagar
Ahmadnagar
MAHARASHTRA
413736
India 
Phone  8502879583  
Fax    
Email  drsaumi@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Saumi Rakesh Sinha  
Designation  Associate professor  
Affiliation  Dr APJ AK College of Physiotherapy 
Address  503 Department of cardiorespiratory Dr APJ Abdul Kalam College of Physiotherapy pravara institute of medical sciences Loni 413736 taluka Rahata distric Ahmadnagar
503 Department of cardiorespiratory Dr APJ Abdul Kalam College of Physiotherapy pravara institute of medical sciences Loni 413736 taluka Rahata distric Ahmadnagar
Ahmadnagar
MAHARASHTRA
413736
India 
Phone  8502879583  
Fax    
Email  drsaumi@gmail.com  
 
Source of Monetary or Material Support  
503 Department of cardiorespiratory Dr APJ Abdul Kalam College of Physiotherapy pravara institute of medical sciences Loni 413736 taluka Rahata distric Ahmadnagar 
 
Primary Sponsor  
Name  Dr APJ Abdul Kalam College Of 
Address  503 Department of cardiorespiratory Dr APJ Abdul Kalam College of Physiotherapy pravara institute of medical sciences Loni 413736 taluka Rahata distric Ahmadnagar 
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 Revati Tekale  Dr APJ Abdul Kalam College of Physiotherapy PMT  Department of Cardiorespiratory Physiotherapy Loni Maharashtra
Ahmadnagar
MAHARASHTRA 
08010371801

revatitekale15@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr.APJ Abdul kalam collage of physiotherapy  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J984||Other disorders of lung,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Breathing control, Diaphragmatic Breathing, Segmental Breathing &Thoracic Expansion, Thoracic Mobility  Group B- Breathing control, Diaphragmatic Breathing, Segmental Breathing &Thoracic Expansion, Thoracic Mobility (3 session per week.3 sets in a 20 minute) EXERCISE DOSAGE Breathing control exercise Segmental Breathing Diaphragmatic Breathing 25 Repetition, 3sets/per session/ 3 Times per week  
Comparator Agent  Diaphargmatic Breathing, segmental Breathing, Thoracic Expansion, Thoracic Mobility   Diaphargmatic Breathing, segmental Breathing, Thoracic Expansion, Thoracic Mobility (3 Session Per Week. 3 Sets in a 20 minutes) EXERCISE DOSAGE Diaphragmatic Breathing Segmental Breathing Thoracic Expansion Thoracic Mobility 25 Repetition,3sets/per session/ 3 Times per week  
Intervention  Pursed lip breathing, Diaphragmatic Breathing, segmental breathing,Thoracic Expansion &Thoracic Mobility Exercise   Group A- Pursed lip breathing, Diaphragmatic Breathing, segmental breathing,Thoracic Expansion &Thoracic Mobility Exercise (3Session per week. 3 sets in a 20 minute) EXERCISE DOSAGE Pursed lip breathing Diaphragmatic Breathing Segmental Breathing Thoracic Expansion Thoracic mobility 25 Repetitions, 3sets/per session/3 times per week  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  18 to 60 years
Both male and female patients
Patients with Subacute and chronic asthma

 
 
ExclusionCriteria 
Details  History of respiratory infection less than 2 months
Patients with Severe airflow obstruction (as per GOLD criteria)
Patients with Chronic Respiratory Failure requiring supplemental oxygenation
Patients with cardiac, neurological musculoskeletal problem
Patients with mental disorders
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
PEFR – To be measured by Peak flow meter
Chest expansion- To be measured at three levels-
QOL- Asthma Quality of Life Questionnaire
 
0 week , 2 week 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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)   15/08/2025 
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="6"
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  

Introduction

Asthma is a common chronic inflammatory condition.The prevalence of asthma in adults (18 years and above) was 4.5% based on the National Health and Morbidity Survey 2006. Bronchial asthma is defined as a chronic inflammatory Disorder of the airways . There are many cells and cellular Elements play a role in the inflammatory reaction of the soft tissue of the lungs. The condition is also known to be Associated with obstruction of the airways that is always reversible with the interventions inflammation also causes an increase in bronchial hyper responsiveness to The stimuli which may lead to asthmatic symptoms like recurrent episodes of wheezing, shortness of breath, tightness of chest, and coughing This thickening of the soft tissue in airways may cause narrowing of the airways and obstruct the air flowing in and out of the lung and thus, causes rapid breathing pattern, as seen in asthmatic patients.

 

Need for study

Currently there is no treatment for bronchial asthma. Medication improves the symptoms but does not cure them. The symptoms of bronchial asthma may be reduced by certain breathing strategies. This study focusses on comparing the effectiveness of breathing strategies like pursed lip breathing and breathing control on PEFR, chest expansion and HRQoL in bronchial asthma patient.

Research question: will there be any effect of breathing control and pursed lip breathing on peak expiratory flow rate, chest expansion and HR QoL in bronchial asthma patient.

Hypothesis :

·       Null hypothesis: There will be no effect of breathing control and pursed lip breathing on peak expiratory flow rate on chest expansion HR QOL in bronchial asthma patient .

·       Alternative hypothesis: There will be effect of Breathing control and pursed lip breathing on peak expiratory flow rate on chest expansion HR QoL in bronchial asthma patients .

Aim of the study:

 Aim of the study is to investigate the effect of Breathing control and pursed lip breathing on peak expiratory flow rate on chest expansion HR QoL in bronchial asthma patient

Objectives of study:

·       To evaluate the effect of effect of Breathing control and pursed lip breathing on peak expiratory flow rate

·       To evaluate the effect of Breathing control and pursed lip breathing on chest expansion in bronchial asthma patients.

·       To evaluate the effect of breathing control and pursed lip breathing on HRQoL in bronchial asthma patients.

Review Of Literature:

1)     Hasson et al (2024): This study aimed to evaluate the effectiveness of a combined breathing techniques program on asthma control. Conducted at the Allergy and Asthma Centre of Al-Diwaniyah Teaching Hospital, the pre-experimental study involved 85 adult asthma patients who were assessed using the Asthma Control Questionnaire (ACQ). The program incorporated the Buteyko breathing technique, pursed lip breathing, and proper inhalation techniques. Findings indicated that participants had poor asthma control prior to the program, but showed significant improvement in their asthma control scores after three weeks of program implementation (p-value < 0.001). These results suggest that integrating these breathing techniques and correct inhalation practices can effectively enhance asthma management.

2)     Kusuma, E.,et al 2021. This study aimed to evaluate the effectiveness of Buteyko breathing versus asthma exercises in reducing asthma symptoms. Asthma, a chronic inflammatory disease exacerbated by factors like air pollution and urbanization, necessitates alternative treatments alongside standard care. The research employed a true experimental design with a quantitative approach, involving 18 participants who were randomly assigned to either the Buteyko breathing group or the asthma exercise group. Over a two-week period, participants’ symptoms were assessed using a weekly asthma symptom questionnaire. Statistical analysis revealed significant improvements in asthma symptom scores for both groups by the end of the study (p < 0.05). However, the Buteyko breathing group demonstrated a more substantial reduction in symptoms compared to the asthma exercise group, with a higher effect size (eta squared 0.99 versus 0.94). Consequently, the study concluded that Buteyko breathing is more effective than asthma exercises in alleviating asthma symptoms.

3)     Arie Sulistiyawati et al 2020; study This investigated the impact of Pursed-Lip Breathing (PLB) on respiratory rate (RR) in asthma patients at the Pulmonary Clinic, TNI AU dr. M Salamun Bandung Hospital. Using a quasi-experimental design with a non-equivalent control group, 51 out of 106 asthma patients were selected based on specific criteria. Participants performed PLB according to a standardized procedure. The results demonstrated a significant reduction in RR, from an average of 23.90 before the exercise to 19.94 afterward (p<0.05). This suggests that PLB effectively lowers RR in asthma patients, indicating its potential benefit in managing asthma symptoms.

4)     RAY SURESH;Asthma, a respiratory condition with an immunological basis, can be managed effectively with non-pharmacological treatments like pursed lip breathing (PLB). A quasi-experimental study with a one-group pre-test post-test design assessed the impact of PLB on asthmatic patients over four weeks. Using a sample of 15 adults from hospital OPDs and clinics, the research revealed significant improvements in respiratory parameters, with pre-test and post-test means of 11.13 (SD 1.884) and 6.4 (SD 2.70) respectively, and a p-value <0.00001. The findings indicate that incorporating PLB can substantially enhance respiratory function and quality of life for asthma patients. Healthcare professionals should prioritize such self-care management techniques, empowering patients with effective strategies to manage their condition, thereby reducing readmissions and healthcare costs.

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Materials and Methodology:

·       Source of data: data will be collected from patients of Dr.Vitthalrao Vikhe Patil, Rural Hospital, Loni

·       Study type: Randomised controlled trial

·       Study setting: Dr. A.P. J Abdul kalam college of physiotherapy

·       Sample size:45

·       Study duration:6 months

Selection criteria:

1.     Inclusion criteria:

1.     Age: 18 to 60 years

2.     Both male and female patients

3.     Patients with Subacute and chronic asthma  (as per GOLD criteria)

 

 

2.     Exclusion criteria:

1.History of respiratory infection < 2 months

2.Patients with Severe airflow obstruction (as per GOLD criteria)

3. Patients with Chronic Respiratory Failure requiring supplemental oxygenation.

4. Patients with cardiac, neurological , musculoskeletal problem

5. Patients with mental disorders.

 

Outcome measures:

1.     PEFR – To be measured by Peak flow meter     

2.     Chest expansion- To be measured at three levels-

3.     QOL- Asthma Quality of Life Questionnaire

Procedure:

1.     Exercise Protocol will be prepared and ethical clearance will be obtained from the IEC.

2.     The Participants will be selected based on the eligibility criteria.

3.     Informed consent will be obtained from the participants and demographic data will be recorded.

  1. Participants will be selected according to inclusion and exclusion criteria.
  2.  Participants will be randomly allocated to 3 groups, Group A, Group B and Group C. There will be 15 patients in each group.
  3. Baseline measurements will be taken for outcome measures.

 

 

  1. Participants will be administered exercise protocol for 2 weeks. Frequency of exercise protocol will be 3 times per week.
  2. Prior assessment of the participants will be done for demographic data.
  3. Group A  will receive Pursed lip breathing, diaphragmatic and segmental breathing exercises, thoracic expansion exercises, and thoracic mobility exercises.
  4. Group B will receive Breathing control exercises, segmental and diaphragmatic breathing exercises.
  5. Group C will receive Diaphragmatic breathing, thoracic expansion and thoracic mobility ,Diaphragmatic and Segmental breathing.ag

12.  Measurements will be taken again after completion of the protocol.


 

Result and Analysis: will be done after the completion of the protocol.

15

Selection of patients to inclusion and exclusion criteria

Preparation of protocol

Randomly distributed in two group

 

Ethical approval from IEC

 

 

 

 

 

 

 


              

Group B                       N=15                   

 

Pre intervention

Group C = 15         control group

Result and analysis done

Group A = 15

Group A                       N=15                   

 

 Post intervention

Group B = 15              experimental group

Group C               n=15           

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


                                                EXERCISE PROGRAM

     Group A- Pursed lip breathing, Diaphragmatic Breathing, segmental breathing,Thoracic Expansion &Thoracic Mobility Exercise (3Session per week. 3 sets in a 20 minute)

EXERCISE

DOSAGE

Pursed lip breathing

Diaphragmatic Breathing

Segmental Breathing

Thoracic Expansion

Thoracic mobility

25 Repetitions, 3sets/per session/3 times per week

 

       Group B- Breathing control, Diaphragmatic Breathing, Segmental Breathing &Thoracic Expansion, Thoracic Mobility (3 session per week.3 sets in a 20 minute)

EXERCISE

DOSAGE

Breathing control exercise

Segmental Breathing

Diaphragmatic Breathing

25 Repetition, 3sets/per session/

3 Times per week

 

       Group C- Diaphargmatic Breathing, segmental Breathing, Thoracic Expansion, Thoracic Mobility (3 Session Per Week. 3 Sets in a 20 minutes)

EXERCISE

DOSAGE

Diaphragmatic Breathing

Segmental Breathing

Thoracic Expansion

Thoracic Mobility

25 Repetition,3sets/per session/

3 Times per week

 

 

References:

1. Agarwal, D., Gupta, P.  P., & Sood, S. (2017). Assessment for Efficacy of Additional Breathing

Exercises Over Improvement in Health Impairment Due to Asthma Assessed using St. George’s

Respiratory Questionnaire. International journal of yoga, 10(3), 145–151.

2. Bruton, A. et al., (2018). Physiotherapy breathing retraining for asthma: a randomized controlled

trial. The Lancet Respiratory Medicine, 6(1), 19-28.

3. Graeme P. Currie & John F. W. Baker. (2012). Asthma. Oxford: Oxford University Press, pp. 45-68

4.  Michelle  H.  Cameron  &  Linda  Monroe.  (2007).  Physical  Rehabilitation:  Evidence-Based

Examination, Evaluation, and Intervention. Philadelphia: Elsevier Health Sciences, pp. 625 – 642.

5.  O.  P.  Jaggi.  (2006). Asthma  and  Allergies:  Causes,  Prevention  and Treatment.  Delhi:  Orient

Paperbacks, pp. 16-45

6.  Potdar  S  (2018)  A  Comparative  Study  between  the  Effect  of  Breathing  Control  and  Pursed

Lip-Breathing Exercises in COPD Patients on Expiratory Flow Rate. J Physiother Res. 2018, Vol.2

No.4:12 38

7. Wang, Q., Zhang, W., Liu, L., Yang, W., & Liu, H. (2019). Effects of physical therapy on lung

function in  children with  asthma:  Study protocol  for  a systematic  review and  meta-analysis.

Medicine, 98(15), e15226.

8. Wendy Murphy. (2011). Asthma. Minneapolis: Twenty-First Century Books, pp. 17-23.

9. Yokogawa, M., Kurebayashi, T., Ichimura, T., Nishino, M., Miaki, H., & Nakagawa, T., (2018).

Comparison  of  two  instructions  for deep  breathing  exercise:  non-specific  and  diaphragmatic

breathing. Journal of physical therapy science, 30(4), 614–618. 

 
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