Impact of PEP Buddy on Breathing, Exercise, and Sleep in COPD Patients
Effect of PEP Buddy During Aerobic Training on Breathing, Exercise, and Sleep Quality in COPD Patients
This study is testing whether using the PEP Buddy device during exercise can help people with COPD breathe better, exercise more easily, and sleep well.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 55 Years to 65 Years |
| Sex | All |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Giza, Dokki) |
| Trial ID | NCT06290245 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of the PEP Buddy device in improving breathing, exercise tolerance, and sleep quality among patients with chronic obstructive pulmonary disease (COPD). It focuses on patients aged 55-65 with moderate to severe COPD, utilizing positive expiratory pressure (PEP) during aerobic exercise to enhance self-management and reduce dyspnea. The study aims to demonstrate that PEP can lead to significant improvements in quality of life by addressing common symptoms associated with COPD. Participants will engage in a structured exercise program while using the PEP Buddy device to maximize benefits.
Who should consider this trial
Good fit: Ideal candidates for this study are COPD patients aged 55-65 with moderate to severe disease and a BMI indicating class II obesity.
Not a fit: Patients with very severe COPD, lung cancer, or other significant comorbidities that interfere with exercise or device use may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance the quality of life for COPD patients by improving their breathing, exercise capacity, and sleep quality.
How similar studies have performed: Previous studies have shown that PEP devices can improve symptoms in over 70% of COPD patients, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Giza, Dokki
- Faculty of Physical Therapy — Giza, Dokki, Egypt (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.