Clinical trial NCT06290245: PEP Buddy Impact on Breathing, Exercise, and Sleep Quality in COPD Patients
Official title: Effect of PEP Buddy During Aerobic Training on Breathing, Exercise, and Sleep Quality in COPD Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: chronic obstructive pulmonary disease
quality of life
sleep quality
positive expiratory pressure
exercise
dyspnea
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-03-04
Enrollment: 90
Sex: ALL
Minimum age (years): 55
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: dyspnea
timeFrame: baseline and after 8 weeks
Secondary outcomes:
measure: pulmonary function
timeFrame: baseline and after 8 weeks
measure: exercise capacity
timeFrame: baseline and after 8 weeks
measure: Sleep quality
timeFrame: baseline and after 8 weeks
measure: Health-related quality of life (HRQoL)
timeFrame: baseline and after 8 weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy
state: Dokki
Study officials:
References: