PEP Buddy Impact on Breathing, Exercise, and Sleep Quality in COPD Patients

NCT ID: NCT06290245

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-23
• Study Completion Date: 2025-08-01

Brief 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). 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.

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

study group

the participants will receive combined PEP Buddy plus the same exercise protocol as in the control group three times per week for eight weeks

Group Type: EXPERIMENTAL

PEP Buddy

Intervention Type: DEVICE

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 exercise

Intervention Type: OTHER

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).

control group

the participants will perform an aerobic exercise in the form of cycling three times per week for eight weeks

Group Type: ACTIVE_COMPARATOR

aerobic exercise

Intervention Type: OTHER

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).

Interventions

PEP Buddy

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

Intervention Type: DEVICE

aerobic exercise

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).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• • 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

Exclusion Criteria

• • 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
• 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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ebtesam Nabil

lecturer at Physical Therapy Department for Cardiovascular/Respiratory Disorder and Geriartics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Physical Therapy

Giza, Dokki, Egypt

Countries

Egypt

Other Identifiers

P.T.REC/012/005045

Identifier Type: -

Identifier Source: org_study_id