An interventional study of PEP Buddy and aerobic exercise in Pulmonary Disease, Chronic Obstructive, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 55 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-08-22.
Sponsored by Cairo University · Not applicable, Interventional, and Supportive care
Exercise intolerance and sleeping problems are among the most common symptoms experienced by patients with chronic obstructive pulmonary disease (COPD), which is associated with lung dynamic hyperinflation (DH). There was evidence that positive expiratory pressure (PEP), which less costly devices could offer, could reduce DH.
A positive expiratory pressure device improved COPD-related symptoms in more than 70% of patients with COPD.
PEP buddy is an adjunct to current COPD therapies, such as inhalers and pulmonary rehabilitation. It provides a tool for self-management and breathing re-training, reducing dyspnea and improving quality of life.
PEP devices have been wildly used to reduce breathing frequency and expiratory flow limitation, change breathing patterns, improve gas exchange, as well as result in less airway collapse and air-trapping in patients with COPD.
Increasing COPD disease severity promotes a negative impact on exercise tolerance and magnifies the level of disability. Physical activity programs appear to safely ameliorate these COPD consequences, conferring beneficial effects on dyspnea and health-related quality of life.
The combination of PEP during aerobic exercise helps to get the most benefits from the exercise for a longer time and little dyspnea and fatigue.
4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.
This study's enrollment of 60 is below the median of 70 across 2,926 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
All gender COPD patients
Exclusion Criteria:
Very severe COPD - Lung cancer
the participants will receive combined PEP Buddy plus the same exercise protocol as in the control group three times per week for eight weeks
Device: PEP Buddy · Other: aerobic exercise
the participants will perform an aerobic exercise in the form of cycling three times per week for eight weeks
Other: aerobic exercise
It is a hands-free, oral PEP device (PEP buddy) which held by the patient's lips like a whistle and is attached to a necklace/lanyard. Different grades of PEP-buddy generate expiratory pressures of 5-17cm H2O
Exercise training will start and finish with a 5-minute warm-up and cool-down on the cycle ergometers at (40% of PHR). The cycling active phase will last for 30 min. at 70% of HRmax (moderate-intensity continuous exercise).
dyspnea
it will be evaluated by mMRC dyspnea scale. it is a self-rating tool to measure the degree of disability that breathlessness poses on day-to-day activities on a scale from 0 to 4: 0, no breathlessness except on strenuous exercise; 1, shortness of breath when hurrying on the level or walking up a slight hill; 2, walks slower than people of same age on the level because of breathlessness or has to stop to catch breath when walking at their own pace on the level; 3, stops for breath after walking ∼100 m or after few minutes on the level; and 4, too breathless to leave the house, or breathless when dressing or undressing
Time frame: baseline and after 8 weeks
pulmonary function
by using spirometer, forced expiratory volume in the first second (FEV1), forced vital capacity (FVC), the ratio of forced expiratory volume in the first second and forced vital capacity (FEV1/FVC) will be measured
Time frame: baseline and after 8 weeks
exercise capacity
six-minute walk test is a sub-maximal exercise test that will be used to assess aerobic capacity. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity
Time frame: baseline and after 8 weeks
Sleep quality
Sleep Quality NRS is a single-item measure that instructs the patient to "select the number that best describes the quality of his sleep during the past 24 hours," where 0 is best possible sleep and 10 is worst possible sleep
Time frame: baseline and after 8 weeks
Health-related quality of life (HRQoL)
St. George Respiratory Questionnaire is Disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. it includes 50 items of 3 components (Part 1 : Symptoms component (frequency \& severity) with a 1, 3 or 12-month recall (best performance with 3- and 12-month recall); Part 2: Activities that cause or are limited by breathlessness; Impact components (social functioning, psychological disturbances resulting from airways disease) refer to current state as the recall). Scores range from 0 to 100, with higher scores indicating more limitations.
Time frame: baseline and after 8 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive→
Cairo University