Ireland
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Recruiting Observational

The Effect of Bottle PEP Exercise on Expiratory Muscle Thickness, Strength, and Balance Parameters in Parkinson's Disease Patients

NCT07680725 · tracked via the Priya Life Science Turkey tracker
Phase
Observational
Started
2025-10-01
Last updated
2026-07-02

Condition(s) studied

Parkinson Disease (PD)

Study summary

Parkinson's disease (PD) is a progressive neurodegenerative disorder characterized by rigidity, tremor, postural instability, bradykinesia, and autonomic dysfunction. It is a common movement disorder worldwide. Motor impairments in PD patients are not limited to the muscles of the extremities; the neck, upper respiratory tract, and respiratory muscles are also affected. The resulting pulmonary dysfunction is one of the main factors contributing to morbidity and mortality in PD patients.

Respiratory muscle exercise programs have been used to improve lung and swallowing function in patients with Parkinson's disease and other similar neurodegenerative disorders. Studies of inspiratory muscle exercise in Parkinson's patients have reported improvements in inspiratory muscle strength and endurance. Similarly, expiratory muscle exercise protocols have been shown to increase maximum expiratory pressure (MEP) and cough effectiveness. However, studies on expiratory muscle strengthening are lacking in the literature.

Positive expiratory pressure (PEP) devices are used to clear airway secretions and feature a resistance that provides resistance during exhalation. This creates a positive pressure that stabilizes the airways during exhalation and prevents airway collapse. Although there are many PEP devices available on the market, the bottle-PEP, a therapist-made device, is used because it can be produced easily and at low cost. The bottle-PEP device consists of a bottle filled with at least 10 cm of water and a tube placed inside the bottle. Although information on strengthening expiratory muscles is traditionally found in the literature, there is no data in the literature on the effect of bottle-PEP use on expiratory muscle strength, especially in Parkinson's patients. A review of the literature shows that the effect of expiratory strengthening on balance has not been studied before.

This study aimed to demonstrate the effects of the bottle-PEP device, used in addition to expiratory muscle strengthening, on expiratory muscle thickness, strength, and balance.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * Patients with a confirmed Parkinson's diagnosis who are being monitored * Those aged 18-75 * Patients who are ambulatory Exclusion Criteria: * Patients with acquired primary motor neuron disease (ischemic/hemorrhagic stroke, intracranial mass) and additional neurological diagnoses * Patients with hearing and cognitive impairments that prevent them from understanding or performing the exercise program * Presence of concomitant acute or chronic lung disease * History of thoracic or abdominal surgery * Severe heart disease * Active cancer * Mini-Mental State Examination (MMSE) score ≤ 24 * Active smoking

Primary outcome measure(s)

  • Diaphragm and intercostal muscle thickness — Will be performed using an ultrasound device before treatment, at the end of treatment (8th week), and 8 weeks after the completion of treatment (16th week)
    In this study, ultrasonography will be used to measure muscle thickness at the end of inspiration and expiration. The thickness of the diaphragm and intercostal muscles will be measured in millimeters.

Trial sites (1)

FacilityCityRegionStatus
Marmara University Medical Faculty Istanbul Maltepe Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07680725 on ClinicalTrials.gov ↗ ← All trials in Turkey