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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorMarmara University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with a confirmed Parkinson's diagnosis who are being monitored

Those aged 18-75

Patients who are ambulatory

Disqualifiers

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

Trial population

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

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

42 Participants
are grouped into 2 trial groups
Group A: Bottle- PEP
Group B: Expiratory exercise

Trial outcomes

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.

Time frame
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

1

Pulmonary Function Tests

Forced Vital Capacity (FVC), FEV1 (Forced Expiratory Volume in 1 second). Values will be measured in liters.

Time frame
Will be measured using spirometry before treatment, at the end of treatment (8th week), and 8 weeks after the completion of treatment (16th week)
2

Berg Balance Scale

The Berg Balance Test is an assessment comprising 14 tests that evaluate the ability to maintain balance in different positions, during changes in posture and whilst in motion. It is scored out of a total of 56 points, with a higher score indicating better balance.

Time frame
Will be evaluated before treatment, at the end of treatment (8th week), and 8 weeks after the completion of treatment (16th week).
3

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

MIP: Measures the strength of the muscles used to inhale (mainly the diaphragm and other inspiratory muscles). It is the maximum pressure a person can generate while trying to inhale forcefully against a blocked airway. MEP: Measures the strength of the muscles used to exhale (mostly abdominal and intercostal muscles). It is the maximum pressure generated during a forceful exhalation against a blocked airway.

Time frame
Will be evaluated before treatment, at the end of treatment (8th week), and 8 weeks after the completion of treatment (16th week).]
4

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

Parkinson's Disease Quality of Life Questionnaire (PDQ-39), used to assess patients' quality of life, consists of 39 multiple-choice items covering eight factors (mobility, activities of daily living, emotional well-being, stigma, social support, cognitive functions, communication, and physical discomfort). Both the sub-scale scores and the total score are calculated out of 100 using a formula. Higher scores indicate a lower quality of life.

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

Other outcomes

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