Effect of Airofit Pro Device on Lung Function, Capacity and Quality of Life in COPD: A Protocol for Randomised Controlled Trial

Introduction: Chronic Obstructive Pulmonary Disease (COPD) is a long-term lung disease that causes difficulty breathing due to airflow blockage. Common causes of the condition include smoking cigarettes, air pollution, and exposure to irritants. Symptoms of COPD include coughing, wheezing, and short...

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Main Authors: Pooja Ramesh Tiwari, Vishnu Vardhan
Format: Article
Language:English
Published: JCDR Research and Publications Private Limited 2025-04-01
Series:Journal of Clinical and Diagnostic Research
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Online Access:https://jcdr.net/articles/PDF/20896/74765_CE[Ra1]_F(IS)_QC(PS_SS)_PF1(VD_SS)_redo_PFA(IS)_PB(VD_IS)_PN(IS).pdf
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author Pooja Ramesh Tiwari
Vishnu Vardhan
author_facet Pooja Ramesh Tiwari
Vishnu Vardhan
author_sort Pooja Ramesh Tiwari
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description Introduction: Chronic Obstructive Pulmonary Disease (COPD) is a long-term lung disease that causes difficulty breathing due to airflow blockage. Common causes of the condition include smoking cigarettes, air pollution, and exposure to irritants. Symptoms of COPD include coughing, wheezing, and shortness of breath. Chest physiotherapy is essential for managing COPD, utilising techniques such as chest percussion, vibrations, and breathing exercises to clear mucus from the lungs, enhance lung function, and facilitate easier breathing. This therapeutic approach can improve the Quality of Life (QoL) for COPD patients by alleviating symptoms and preventing complications. The Airofit Pro device shows potential for both evaluating and treating patients with COPD and merits further investigation. Need of the Study: The present study intends to examine the effects of the Airofit Pro device on Maximal Expiratory Pressure (MEP), pulmonary function, functional capacity, and QoL in individuals diagnosed with COPD. Participants with COPD will be recruited for this randomised controlled trial based on predetermined criteria, with caregiver consent obtained. Aim: To evaluate the effects of the Airofit Pro device on MEP, pulmonary functions, functional capacity, and QoL in patients with COPD. Materials and Methods: The present experimental study protocol for a randomised controlled trial will be conducted in the Department of Respiratory Medicine at Acharya Vinoba Bhave Rural Hospital, associated with Ravi Nair Physiotherapy College, Wardha, Maharashtra, India, from May 2024 to April 2025, following approval from the Ethical Committee DMIHER(DU)/IEC/2024/173. The study is registered with Clinical Trail Registry of India (CTRI) CTRI/2024/04/065110. Participants will be assigned to two groups: Group A will undergo conventional physiotherapy for COPD, while Group B will receive conventional physiotherapy along with the Airofit Pro device. Data will be collected and analysed statistically. Each participant will undergo a 2-week rehabilitation period after enrollment, with assessments conducted at the beginning and end of the rehabilitation period. Follow-up evaluations will occur after one week. Outcome variables will be analysed using descriptive statistics, which include measurements such as minimum, maximum, mean, standard deviation, standard error, and 95% confidence intervals for parametric data. The Kolmogorov-Smirnov test will be used to assess the normality of continuous outcome variables at a 5% significance level (p≤0.05). If the null hypothesis is rejected, indicating that the data is not normally distributed, non parametric tests will be used to evaluate significance. The t-test will be employed at a 5% significance level (p≤0.05) to compare the Control group (conventional chest physiotherapy for COPD) and the Intervention group (conventional chest physiotherapy paired with the Airofit Pro device for COPD). Non normally distributed data will be described using measures such as mean, median, lower quartile, and upper quartile, and significance will be assessed using the Mann-Whitney test.
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spelling doaj-art-d984b79ecd91427ea6ff5707b8a70a532025-08-20T02:18:57ZengJCDR Research and Publications Private LimitedJournal of Clinical and Diagnostic Research2249-782X0973-709X2025-04-01194YK01YK0610.7860/JCDR/2025/74765.20896Effect of Airofit Pro Device on Lung Function, Capacity and Quality of Life in COPD: A Protocol for Randomised Controlled TrialPooja Ramesh Tiwari0Vishnu Vardhan1Resident, Department of Cardiovascular and Respiratory Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra, India.Professor, Department of Cardiovascular and Respiratory Physiotherapy, Ravi Nair Physiotherapy College, Datta Meghe Institute of Higher Education and Research, Wardha, Maharashtra, India.Introduction: Chronic Obstructive Pulmonary Disease (COPD) is a long-term lung disease that causes difficulty breathing due to airflow blockage. Common causes of the condition include smoking cigarettes, air pollution, and exposure to irritants. Symptoms of COPD include coughing, wheezing, and shortness of breath. Chest physiotherapy is essential for managing COPD, utilising techniques such as chest percussion, vibrations, and breathing exercises to clear mucus from the lungs, enhance lung function, and facilitate easier breathing. This therapeutic approach can improve the Quality of Life (QoL) for COPD patients by alleviating symptoms and preventing complications. The Airofit Pro device shows potential for both evaluating and treating patients with COPD and merits further investigation. Need of the Study: The present study intends to examine the effects of the Airofit Pro device on Maximal Expiratory Pressure (MEP), pulmonary function, functional capacity, and QoL in individuals diagnosed with COPD. Participants with COPD will be recruited for this randomised controlled trial based on predetermined criteria, with caregiver consent obtained. Aim: To evaluate the effects of the Airofit Pro device on MEP, pulmonary functions, functional capacity, and QoL in patients with COPD. Materials and Methods: The present experimental study protocol for a randomised controlled trial will be conducted in the Department of Respiratory Medicine at Acharya Vinoba Bhave Rural Hospital, associated with Ravi Nair Physiotherapy College, Wardha, Maharashtra, India, from May 2024 to April 2025, following approval from the Ethical Committee DMIHER(DU)/IEC/2024/173. The study is registered with Clinical Trail Registry of India (CTRI) CTRI/2024/04/065110. Participants will be assigned to two groups: Group A will undergo conventional physiotherapy for COPD, while Group B will receive conventional physiotherapy along with the Airofit Pro device. Data will be collected and analysed statistically. Each participant will undergo a 2-week rehabilitation period after enrollment, with assessments conducted at the beginning and end of the rehabilitation period. Follow-up evaluations will occur after one week. Outcome variables will be analysed using descriptive statistics, which include measurements such as minimum, maximum, mean, standard deviation, standard error, and 95% confidence intervals for parametric data. The Kolmogorov-Smirnov test will be used to assess the normality of continuous outcome variables at a 5% significance level (p≤0.05). If the null hypothesis is rejected, indicating that the data is not normally distributed, non parametric tests will be used to evaluate significance. The t-test will be employed at a 5% significance level (p≤0.05) to compare the Control group (conventional chest physiotherapy for COPD) and the Intervention group (conventional chest physiotherapy paired with the Airofit Pro device for COPD). Non normally distributed data will be described using measures such as mean, median, lower quartile, and upper quartile, and significance will be assessed using the Mann-Whitney test.https://jcdr.net/articles/PDF/20896/74765_CE[Ra1]_F(IS)_QC(PS_SS)_PF1(VD_SS)_redo_PFA(IS)_PB(VD_IS)_PN(IS).pdfchronic obstructive pulmonary diseasemaximal expiratory pressuremaximal inspiratory pressuresix-minute walk test
spellingShingle Pooja Ramesh Tiwari
Vishnu Vardhan
Effect of Airofit Pro Device on Lung Function, Capacity and Quality of Life in COPD: A Protocol for Randomised Controlled Trial
Journal of Clinical and Diagnostic Research
chronic obstructive pulmonary disease
maximal expiratory pressure
maximal inspiratory pressure
six-minute walk test
title Effect of Airofit Pro Device on Lung Function, Capacity and Quality of Life in COPD: A Protocol for Randomised Controlled Trial
title_full Effect of Airofit Pro Device on Lung Function, Capacity and Quality of Life in COPD: A Protocol for Randomised Controlled Trial
title_fullStr Effect of Airofit Pro Device on Lung Function, Capacity and Quality of Life in COPD: A Protocol for Randomised Controlled Trial
title_full_unstemmed Effect of Airofit Pro Device on Lung Function, Capacity and Quality of Life in COPD: A Protocol for Randomised Controlled Trial
title_short Effect of Airofit Pro Device on Lung Function, Capacity and Quality of Life in COPD: A Protocol for Randomised Controlled Trial
title_sort effect of airofit pro device on lung function capacity and quality of life in copd a protocol for randomised controlled trial
topic chronic obstructive pulmonary disease
maximal expiratory pressure
maximal inspiratory pressure
six-minute walk test
url https://jcdr.net/articles/PDF/20896/74765_CE[Ra1]_F(IS)_QC(PS_SS)_PF1(VD_SS)_redo_PFA(IS)_PB(VD_IS)_PN(IS).pdf
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