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

Not Applicable

Recruiting

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Device: PEP Buddy; Other: aerobic exercise

• Registration Number: NCT06290245
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study First Submitted: 2024-02-21
• Study First Submitted QC: 2024-02-29
• Study First Posted: 2024-03-04
• Study Start: 2024-03-23
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-08
• Last Update Posted: 2024-07-09
• Primary Completion: 2024-10
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study group	aerobic exercise	the participants will receive combined PEP Buddy plus the same exercise protocol as in the control group three times per week for eight weeks
study group	PEP Buddy	the 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	aerobic exercise	the participants will perform an aerobic exercise in the form of cycling three times per week for eight weeks

Primary Outcome Measures

Name	Time	Method
dyspnea	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

Secondary Outcome Measures

Name	Time	Method
exercise capacity	baseline and after 8 weeks	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
Sleep quality	baseline and after 8 weeks	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
pulmonary function	baseline and after 8 weeks	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
Health-related quality of life (HRQoL)	baseline and after 8 weeks	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.

Trial Locations

Locations (1)

Faculty of Physical Therapy; 🇪🇬 Giza, Dokki, Egypt