- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06472167
Breathing Exercises on Lung Function
May 27, 2025 updated by: Mohamed Abd Elmoniem Mohamed, Mansoura University Hospital
Impact of Breathing Exercises on Lung Function in Chronic Airway Diseases
aim of this study is to evaluate the efficacy of pulmonary rehabilitation program as a non-pharmacological treatment method to: Improve functional capacity as assessed by six-minute walking distance (6MWD) test.
Improve dyspnea level as assessed by Medical Research Council (MRC) dyspnea scale.
Improve pulmonary function tests and arterial blood gas.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Breathing exercises offer numerous benefits for individuals with chronic airway diseases, such as chronic obstructive pulmonary disease (COPD), asthma and bronchiectasis.
These exercises help improve respiratory function, reduce symptoms, and enhance the overall quality of life.Techniques such as diaphragmatic breathing, incentive spirometer and pursed lip breathing help patients use their lungs more effectively.
Breathing exercises can enhance lung function by increasing the efficiency of the respiratory muscles and improving ventilation.
Asthma is a chronic inflammatory disorder of the airways classified as intermittent or persistent (mild, moderate or severe), according to the presence of diurnal and nocturnal symptoms, necessity of medication, frequency of exacerbation, physical activity limitations and pulmonary function.
All of these symptoms deteriorate in the patient's quality of life and psychological well-being and restrict daily living physical activities (DLPA).
Asthma symptoms experienced during daily living physical activities (DLPA) or the fear of triggering symptoms may keep asthmatic subjects from engaging in physical exercise, and the patients tend to be less physically active and less conditioned than healthy individuals.
In addition, asthmatic patients have higher levels of anxiety and depression that have been shown to be associated with an increased number of exacerbations and the diagnosis of severe asthma.
These psychosocial disorders can modify the respiratory breathing pattern, which leads to irregular breathing, frequent sighing, and predominant thoracic breathing.
These irregular breathing patterns increase the number of respiratory (breathlessness, chest tightness and pain) and non-respiratory symptoms (anxiety, dizziness and fatigue).
Recent Global Initiative for Chronic Obstructive Pulmonary Disease guidelines (GOLD) underline the importance of pulmonary rehabilitation (PR) as a part of an integrative multidisciplinary approach regardless of the stage of disease
Study Type
Interventional
Enrollment (Estimated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mohamed AbdElmoniem
- Phone Number: 01014008473
- Email: dr.m1993@mans.edu.eg
Study Contact Backup
- Name: Mohamed Ahmed Ibrahim
Study Locations
-
-
-
Mansoura, Egypt, 35516
- Recruiting
- Mohamed AbdElmoniem
-
Contact:
- Mohamed AbdElmoniem
- Phone Number: 01014008473
- Email: dr.m1993@mans.edu.eg
-
Principal Investigator:
- Mohamed AbdElmoniem, Lecturer
-
Contact:
- Mohamed Ahmed Ibrahim
- Phone Number: 01014008473
- Email: dr.m1993@mans.edu.eg
-
Sub-Investigator:
- Mohamed Ahmed Ibrahim, Lecturer
-
Sub-Investigator:
- Mohamed Rafat borham, Lecturer
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- The patients fulfilled the criteria for COPD: the presence of a post bronchodilator FEV1 < 80% predicated together with an FEV1/FVC <0.70confirm the presence of airflow limitation that is not fully reversible.
- COPD patients ranging from mild to severe according to GOLD [stages I-IV].
- Asthmatic patients receive medical treatment for at least 6 months; and clinically stable (i.e., no exacerbation or changes in medication for ≥30 days).
- None of the individuals had been engaged in any exercise-training program before participating in the study.
- Optimized medical therapy according to GOLD & Global Initiative for Asthma (GINA)
- Clinically stable COPD and asthmatic patients (not suffering from a recent respiratory tract infection).
- All patients are Ex-smoker
Exclusion Criteria:
- Age <18 years.
- Pregnancy
- Current Smokers
- Patients that are incapable of exercising; unable to understand any questionnaire
- Multiple co- morbidity (e.g., cardiovascular diseases, active cancer)
- Neuromuscular disease as Myasthenia gravis, kypho-scoliosis
- Diaphragmatic Paralysis (paralyzed diaphragm exhibiting abnormal paradoxical movement, i.e., moving in a cranial direction during inspiration).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Chronic airway diseases treated by medication
Chronic airway diseases treated by medication without breathing exercises
|
|
|
Active Comparator: Chronic airway diseases treated by medication with breathing exercises
Chronic airway diseases treated by medication and breathing exercises
|
Breathing exercises as diaphragmatic breathing exercises and pursued lip breathing and incentive spirometry
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Impact of breathing exercises on Forced expiratory volume on first second (FEV1) in liter
Time Frame: 6 months
|
Effect of Breathing exercises on lung function using spirometry
|
6 months
|
|
Impact of breathing exercises on Forced vital capacity (FVC) in liter
Time Frame: 6 months
|
Effect of Breathing exercises on lung function using spirometry
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mohamed AbdElmoniem, Lecturer of chest medicine faculty of medicine Mansoura university
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2024
Primary Completion (Estimated)
August 10, 2025
Study Completion (Estimated)
December 10, 2025
Study Registration Dates
First Submitted
June 13, 2024
First Submitted That Met QC Criteria
June 21, 2024
First Posted (Actual)
June 25, 2024
Study Record Updates
Last Update Posted (Actual)
May 29, 2025
Last Update Submitted That Met QC Criteria
May 27, 2025
Last Verified
May 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R.24.05.2638
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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