- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07477080
Breathing Exercises Effect on Lung Functions and Chest Expansion in Asthmatics (DB&PLB/PFT)
Effectiveness of Diaphragmatic Breathing and Pursed-Lip Expiration Exercises in Improving Lung Functions in Adult Egyptians With Bronchial Asthma: a Randomized Controlled Clinical Trial
The goal for this clinical trial was to compare the effectiveness of Diaphragmatic Breathing and Pursed-Lip Expiration Exercises in improving lung functions {the Peak Expiratory Flow Rate (PEFR) and Forced Expiratory Volume in 1- second (FEV1)} and Chest Expansion in Egyptian outpatient adults with bronchial asthma.
The research questions were:
- Are Diaphragmatic Breathing Exercises effective in improving lung function parameters?
- Are Pursed-Lip Expiration Exercises effective in improving lung function parameters?
- Which of the two studied breathing exercise is more effective in improving lung function parameters?
All the participants were classified into 2 groups:
Group1:
Diaphragmatic Breathing Exercise training was offered for participants to complete the 8-weeks exercise program (each session lasted about 20 minutes twice daily for 5 days per week).
Group2:
Pursed Lip Breathing Exercise training was offered for participants to complete the 8-weeks exercise program (each session lasted about 20 minutes twice daily for 5 days per week).
The two main parameters which were assessed initially and after completion of the 2-month exercise program were:
- Lung functions {Peak Expiratory Flow Rate (PEFR) and Forced Expiratory Volume in 1-second (FEV1)}
- The chest expansion
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Participants were enrolled from Outpatient Chest Clinic in Ain Shams University Hospitals.
After checking for inclusion and exclusion criteria and signing the informed consent form the following was carried out.
After enrollment of the participants from outpatient chest clinic, their education and interviewing were conducted in a private comfortable room near to chest clinic taking the time for discussion, understanding the 2- month training program and practicing the exercises techniques through first visit, bimonthly visits and the last visit. These visits were the same for the two groups with a difference in the exercise technique (explained in detail in a separate paragraph for each group), these visits included:
A. First visit:
- Thorough history was carefully taken for proper assessment and exclusion of any patients prone to risks.
- Spirometry based- diagnosis was reviewed.
- Measurement of Peak Expiratory Flow Rate (PEFR), Forced Expiratory Volume in 1-second (FEV1) and chest expansion. The techniques and steps of peak flowmeter and chest expansion measurements were explained for participants before assessing these parameters.
- The whole exercises technique was explained carefully and video demonstration on laptop was shown for participants to make sure of their understanding (See Appendix 1).
- Every participant practiced the exercise under supervision, and any mistakes were reviewed, and the exercise was repeated till mastering the technique.
Encouragement of the participants for adherence to exercise program through:
- Explanation of the breathing exercises' benefits to participants which included, increased control over breathing, reduced need for medication, feeling more relaxed, improved health and quality of life and non- respiratory psychological benefits such as decreasing anxiety; these benefits were recorded by previous clinical trials. Regarding the down or up stepping of the asthma medications for the participants, this was completely the chest doctor's responsibility toward their patients.
- Daily self-monitoring sheets regarding days, frequency and duration of exercise should be fulfilled by the participants to improve their compliance motivation, remembering and adherence; the participants were informed about the items in the follow-up sheets to fulfill it properly and were reviewed in the bimonthly follow up visits regularly (See Appendix 2,3).
- WhatsApp group for each arm of the trial for daily follow up monitoring and reinforcement by videos.
- The exercise program and follow up plan were discussed with participants.
- Informed consent was obtained from all the participants.
B- Bimonthly Follow up visits (Three follow up visits along the 2-month exercise program):
- The exercise technique was reviewed with the participants to ensure mastering the technique and the participants practiced the exercise in front of the investigator.
- Discussion about the adherence to the training program and any obstacles were reviewed for simplification.
- Reviewing the printed follow up daily sheets.
- Reinforcing and encouragement of participants to maintain the exercise program.
- No measurements were obtained in follow up visits, only in the first visits initially and the last visit after completion of the 2-month exercise program.
C-The last visit:
- Remeasuring of PEFR, FEV1 and chest expansion after the 2-months exercise program.
- Thanking the participants about their exercise program engagement.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Abbasya
-
Cairo, Abbasya, Egypt
- Ain Shams University Hospitals
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Egyptian adults aged between 18 and 60 years old, both males and females.
- Pulmonary function-based diagnosis for asthma.
- Mild and moderate cases of asthma.
Exclusion Criteria:
- Recent myocardial infarction or acute coronary syndrome.
- Non-cooperative patients.
- Status asthmatics patients.
- Hypoxic patients.
- Asthmatic patients who were associated with other chest and heart diseases.
- Recent pneumothorax or pulmonary embolism.
- Large thoracic or abdominal aortic aneurysm.
- Acute onset of hemoptysis.
- Retinal detachment.
- Intracranial hypertension.
- Patients with dementia.
- Recent brain, eye, ear, nose, abdominal or thoracic surgery.
- Severe uncontrolled hypertension.
- Patients with urinary incontinence.
- Currently admitted to intensive care unit.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Diaphragmatic Breathing Exercise
Diaphragmatic Breathing Exercise training was offered for participants to complete the 8-weeks exercise program (each session lasted about 20 minutes twice daily for 5 days per week).
Relaxation and comfortable positioning of the participant with full support to back and head and relaxation of the abdominal wall (fowler's position).
One hand of the participant placed on the rectus abdominis muscle just inferior to the anterior costal margin and the other hand on chest wall keeping the shoulders relaxed and upper chest quiet during breathing in slowly and deeply through the nose following the abdomen to rise with subsequent slow expiration through pursed lip for three or four times then rest.
Three or four sets were applied in 20 minutes exercising session.
|
Diaphragmatic Breathing Exercise training was offered for participants to complete the 8-weeks exercise program (each session lasted about 20 minutes twice daily for 5 days per week).
Relaxation and comfortable positioning of the participant with full support to back and head and relaxation of the abdominal wall (fowler's position).
One hand of the participant placed on the rectus abdominis muscle just inferior to the anterior costal margin and the other hand on chest wall keeping the shoulders relaxed and upper chest quiet during breathing in slowly and deeply through the nose following the abdomen to rise with subsequent slow expiration through pursed lip for three or four times then rest.
Three or four sets were applied in 20 minutes exercising session.
|
|
Experimental: pursed lip breathing exercise group
Pursed-Lip Expiration Exercise training was offered for participants to complete the 8-weeks exercise program (each session lasted about 20 minutes twice daily for 5 days per week).
Closing the mouth while breathing in slowly through the nose for two counts while keeping shoulders and neck relaxed followed by expiration using pursued lips (as if they mimic whistling) for four counts.
Three or four sets were applied in 20 minutes exercising session.
|
Pursed-Lip Expiration Exercise training was offered for participants to complete the 8-weeks exercise program (each session lasted about 20 minutes twice daily for 5 days per week).
Closing the mouth while breathing in slowly through the nose for two counts while keeping shoulders and neck relaxed followed by expiration using pursued lips (as if they mimic whistling) for four counts.
Three or four sets were applied in 20 minutes exercising session.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in FEV1
Time Frame: 8 weeks
|
Changes in FEV1 were compared within each group before and after intervention by the breathing exercises and between the two groups
|
8 weeks
|
|
Changes in PEFR
Time Frame: 8 WEEKS
|
Changes in PEFR were compared within each group before and after intervention by the breathing exercises and between the two groups
|
8 WEEKS
|
|
Changes in chest expansion
Time Frame: 8 weeks
|
Changes in chest expansion were compared within each group before and after intervention by the breathing exercises and between the two groups
|
8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Wafaa M Qurany, Master,Family medicine, Ain Shams University,Faculty of Medicine
- Study Director: Mohamed F Allam, MD, Professor, Ain Shams University,Faculty of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FMASU MD 152/2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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