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

NCT07680725 | Recruiting

• 1 other identifier: MarmaraU-FTR-SS-01
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease (PD)

Keywords

Parkinson; Parkinson disease; diaphragm thickness; inspiratory muscle; respiratory exercises; bottle-PEP; balance

Outcome Measures

Primary Outcomes (1)

• Diaphragm and intercostal muscle thickness

  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.

  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)

Secondary Outcomes (4)

• Pulmonary Function Tests

  Will be measured using spirometry before treatment, at the end of treatment (8th week), and 8 weeks after the completion of treatment (16th week)

• Berg Balance Scale

  Will be evaluated before treatment, at the end of treatment (8th week), and 8 weeks after the completion of treatment (16th week).

• Maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) measurements

  Will be evaluated before treatment, at the end of treatment (8th week), and 8 weeks after the completion of treatment (16th week).]

• Parkinson's Disease Quality of Life Questionnaire (PDQ-39)

  Will be evaluated before treatment, at the end of treatment (8th week), and 8 weeks after the completion of treatment (16th week).]

Study Arms (2)

Bottle- PEP

Neurological rehabilitation program + bottle-PEP

Expiratory exercise

Neurological rehabilitation program + expiratory strengthening exercises

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 18-75 with a diagnosis of Parkinson's disease who are ambulatory

You may qualify if:

• Patients with a confirmed Parkinson's diagnosis who are being monitored
• Those aged 18-75
• Patients who are ambulatory

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University Medical Faculty

Istanbul, Maltepe, 34854, Turkey (Türkiye)

RECRUITING

Related Publications (7)

• Santos, Mary & Milross, Maree & Alison, J.. (2016). Therapist-Made Bubble-Positive Expiratory Pressure: A Survey of Physiotherapists in Australia. Cardiopulmonary Physical Therapy Journal. 27. 3-10.

  BACKGROUND

• Oberwaldner B, Evans JC, Zach MS. Forced expirations against a variable resistance: a new chest physiotherapy method in cystic fibrosis. Pediatr Pulmonol. 1986 Nov-Dec;2(6):358-67. doi: 10.1002/ppul.1950020608.

  PMID: 3543830 BACKGROUND

• Pitts T, Bolser D, Rosenbek J, Troche M, Okun MS, Sapienza C. Impact of expiratory muscle strength training on voluntary cough and swallow function in Parkinson disease. Chest. 2009 May;135(5):1301-1308. doi: 10.1378/chest.08-1389. Epub 2008 Nov 24.

  PMID: 19029430 BACKGROUND

• Inzelberg R, Peleg N, Nisipeanu P, Magadle R, Carasso RL, Weiner P. Inspiratory muscle training and the perception of dyspnea in Parkinson's disease. Can J Neurol Sci. 2005 May;32(2):213-7. doi: 10.1017/s0317167100003991.

  PMID: 16018157 BACKGROUND

• Troche MS, Huebner I, Rosenbek JC, Okun MS, Sapienza CM. Respiratory-swallowing coordination and swallowing safety in patients with Parkinson's disease. Dysphagia. 2011 Sep;26(3):218-24. doi: 10.1007/s00455-010-9289-x. Epub 2010 Jul 11.

  PMID: 20623304 BACKGROUND

• Torsney KM, Forsyth D. Respiratory dysfunction in Parkinson's disease. J R Coll Physicians Edinb. 2017 Mar;47(1):35-39. doi: 10.4997/JRCPE.2017.108.

  PMID: 28569280 BACKGROUND

• Brown LK. Respiratory dysfunction in Parkinson's disease. Clin Chest Med. 1994 Dec;15(4):715-27.

  PMID: 7867286 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Ozge Kenis Coskun, Professor

  Marmara University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sevim Sensoy, Resident Doctor

CONTACT

905436990767; sensoysevim@gmail.com

Ozge Kenis Coskun, Professor

CONTACT

ozgekenis@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: July 2, 2026
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: July 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)