Pulmonary Disease, Chronic ObstructiveNCT06290245
PEP Buddy Impact on Breathing, Exercise, and Sleep Quality in COPD Patients
A study testing PEP Buddy and aerobic exercise in people with Pulmonary Disease, Chronic Obstructive, run by Cairo University at 1 site in Egypt.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 55 to 65 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- PEP Buddy and aerobic exercise
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Mar 2024to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • All gender COPD patients
- Age will be 55-65 years.
- Moderate to severe COPD patients
- emphysema on CT scan (HU ≥ - 900)
- Their FEV1 will be less than 80% predicted
- Class II obesity (BMI of 35 to < 40)
- Medically stable
- greater than 10 pack-year smoking history
Who cannot join
- • Very severe COPD - Lung cancer
- Lung resection - Lung fibrosis
- Heart failure - Cognitive disorders that affect the device application
- Musculoskeletal or neurological disorders that interfere with an exercise program
- requiring invasive or non-invasive positive pressure ventilation
- inability to speak in complete sentences due to breathlessness
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- suspected elevated intracranial pressure - hemodynamic instability
- recent facial, oral, or skull surgery
- active hemoptysis (more than two tablespoons of frank blood per day)
- pneumothorax - failure to comply with the research protocol.
- uncontrolled hypertension, or other concomitant respiratory diseases
- participate in any research or pulmonary rehabilitation program during the period of this study.
- imaging changes of lung disease such as occupancy, exudation, and interstitial changes on CT scan
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of PEP Buddy During Aerobic Training on Breathing, Exercise, and Sleep Quality in COPD Patients
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.
Read the detailed description
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.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- PEP Buddy, aerobic exercise
- Keywords
- chronic obstructive pulmonary disease, quality of life, sleep quality, positive expiratory pressure, exercise, dyspnea
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Sleep Initiation and Maintenance Disorders, Motor Activity, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEP BuddyDevice
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
aerobic exerciseOther
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).
| Study group | Role | What they receive |
|---|---|---|
| study group | Experimental | the participants will receive combined PEP Buddy plus the same exercise protocol as in the control group three times per week for eight weeks Receives: Device: PEP Buddy; Other: aerobic exercise |
| control group | Active comparator | the participants will perform an aerobic exercise in the form of cycling three times per week for eight weeks Receives: Other: aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline and after 8 weeks
Secondary outcomes (4)
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
Measured: 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
Measured: 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
Measured: 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.
Measured: baseline and after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start23 Mar 2024
- Primary completion25 May 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebtesam Nabil, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06290245
- Sponsor's protocol ID
- P.T.REC/012/005045
- Status last verified
- Aug 2025
- First submitted
- 21 Feb 2024
- Last updated
- 22 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of PEP Buddy During Aerobic Training on Breathing, Exercise, and Sleep Quality in COPD Patients
- ClinicalTrials.gov ID
- NCT06290245
- Acronym / sponsor ID
- P.T.REC/012/005045
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- chronic obstructive pulmonary disease, quality of life, sleep quality, positive expiratory pressure, exercise, dyspnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 23 Mar 2024 (actual)
- Primary completion
- 25 May 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Experimental | Device: PEP Buddy, Other: aerobic exercisethe participants will receive combined PEP Buddy plus the same exercise protocol as in the control group three times per week for eight weeks |
| control group | Active comparator | Other: aerobic exercisethe participants will perform an aerobic exercise in the form of cycling three times per week for eight weeks |
Who may qualify
- Ages
- 55 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- • All gender COPD patients
Key exclusion criteria (13 listed)
- • Very severe COPD - Lung cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEP BuddyIt 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 | Device | study group |
| aerobic exerciseExercise 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). | Other | control group, study group |
Primary outcome
dyspnea
Time frame: baseline and after 8 weeks
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
4 secondary outcomes
pulmonary function
Time frame: baseline and after 8 weeks
exercise capacity
Time frame: baseline and after 8 weeks
Sleep quality
Time frame: baseline and after 8 weeks
Health-related quality of life (HRQoL)
Time frame: baseline and after 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEP Buddy and aerobic exercise in people with Pulmonary Disease, Chronic Obstructive, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dyspnea (time frame: baseline and after 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025; AzTrials last refreshed its copy on 6 Nov 2026.