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

NCT06290245 | Completed

• 1 other identifier: P.T.REC/012/005045
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

chronic obstructive pulmonary disease; quality of life; sleep quality; positive expiratory pressure; exercise; dyspnea

Outcome Measures

Primary Outcomes (1)

• dyspnea

  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

  baseline and after 8 weeks

Secondary Outcomes (4)

• pulmonary function

  baseline and after 8 weeks

• exercise capacity

  baseline and after 8 weeks

• Sleep quality

  baseline and after 8 weeks

• Health-related quality of life (HRQoL)

  baseline and after 8 weeks

Study Arms (2)

study group

EXPERIMENTAL

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; Other: aerobic exercise

control group

ACTIVE COMPARATOR

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

Other: aerobic exercise

Interventions

PEP Buddy 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

study group

aerobic exercise 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; study group

Eligibility Criteria

• Age: 55 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy

Giza, Dokki, 11432, Egypt

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Sleep Initiation and Maintenance Disorders; Motor Activity; Dyspnea

Interventions

Exercise

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavior; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer at Physical Therapy Department for Cardiovascular/Respiratory Disorder and Geriartics

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: March 4, 2024
• Study Start: March 23, 2024
• Primary Completion: May 25, 2025
• Study Completion: August 1, 2025
• Last Updated: August 22, 2025

Record last verified: 2025-08

Locations

EG (1)