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临床试验/CTRI/2025/07/091319
CTRI/2025/07/091319尚未招募2 期

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

Dr APJ Abdul Kalam College Of1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2025年8月15日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
45
试验地点
1
主要终点
PEFR – To be measured by Peak flow meter

研究概览

简要总结

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.

Top of Form

Bottom of Form

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)

  1. Patients with Chronic Respiratory Failure requiring supplemental oxygenation.

  2. Patients with cardiac, neurological , musculoskeletal problem

  3. 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:

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.

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

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

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

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.

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

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.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 18 to 60 years Both male and female patients Patients with Subacute and chronic asthma.

排除标准

  • 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.

结局指标

主要结局

PEFR – To be measured by Peak flow meter

时间窗: 0 week , 2 week

Chest expansion- To be measured at three levels-

时间窗: 0 week , 2 week

QOL- Asthma Quality of Life Questionnaire

时间窗: 0 week , 2 week

次要结局

未报告次要终点

研究者

发起方
Dr APJ Abdul Kalam College Of
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Revati Ravindra Tekale

Dr APJ AK College of Physiotherapy

研究点 (1)

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