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

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.

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Device: PEP Buddy; Other: aerobic exercise

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 Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dokki
    • Giza, Dokki, Egypt, 11432
      • Recruiting
      • Faculty of physical therapy
      • Contact: Ebtesam N Nagy; Phone Number: +201278141946; Email: Dr.EbtesamNagy2@outlook.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: 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; Other: 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).
Active Comparator: control group; the participants will perform an aerobic exercise in the form of cycling three times per week for eight weeks	Other: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
dyspnea	it will be evaluated by Shortness of Breath Questionnaire which is a 24-item patient-completed survey that evaluates the severity of dyspnea during common activities. Each question is scored from 0 ("not at all") to 5 ("unable to do because of breathlessness"), with the sum of all scores representing the overall severity of the breathlessness on a scale of 0-120.	baseline and after 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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.	baseline and after 8 weeks

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: February 21, 2024
• First Submitted That Met QC Criteria: February 29, 2024
• First Posted (Estimated): March 4, 2024

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: positive expiratory pressure; exercise; quality of life; sleep quality; dyspnea; chronic obstructive pulmonary disease
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Lung Diseases, Obstructive; Chronic Disease; Lung Diseases; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: P.T.REC/012/005045

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No