Postural abnormalities (PA) negatively affecting the axial system are part of the symptoms of Parkinson's disease (PD). They occur in more than 20% of patients with PD especially in more advanced stages of the disease, contribute significantly to patient disability, affect respiratory functions, and reduce quality of life. Eighty-five percent of patients with forward trunk flexion (FTF) reported difficulties with swallowing (dysphagia), shortness of breath, and drooling. Previous studies in patients with PD also identified cough disorders (dystussia). Since cough and properly functioning swallowing are key mechanisms for airway protection, impairments in these functions lead to a higher risk of aspiration. The seriousness of this problem is clearly confirmed by the fact that aspiration pneumonia is the leading cause of death in patients with PD.
Among non-pharmacological interventions for airway protection, expiratory muscle strength training (EMST) has been shown to be beneficial in patients with PD. Recent randomized controlled studies demonstrated a significant effect of EMST on dysphagia, dystussia, drooling, and dysarthria in patients with PD.
However, the literature lacks data on the effect of EMST on dystussia in patients with PD and FTF, who, according to previous research, are also affected by restrictive ventilatory impairment, which negatively affects respiratory capacity and, in particular, cough strength.
The aim of this study is to evaluate the effect of EMST on cough, swallowing, respiratory muscle strength, and drooling in patients with PD and forward trunk flexion.
Diagnosis of Parkinson' s disease
Age ≥ 18 years
MoCA score (Montreal Cognitive Assessment) ≥ 19
Score II-IV during the "ON" phase under regular antiparkinsonian medication according to the Modified Hoehn and Yahr Scale
Change in antiparkinsonian medication within the last 3 months prior to study enrollment
Other neurological, orthopedic, cardiovascular, or respiratory comorbidities
Inability to cooperate due to neuropsychological dysfunction
Current smoking history
Parallel
Expiratory muscle strength training
DeviceParticipants will perform a 4-week Expiratory Muscle Strength Training (EMST) program using the EMST150™ device. EMST therapy sessions will be completed at home on 5 days per week, at the participant's convenience, performing five sets of five forceful exhalations through the device. The resistance of the device will be set to 75% of the patient's individual maximum expiratory pressure (MEP). The daily training will take approximately 15 minutes. Device resistance will be recalibrated at visits in weeks 0, 2, and 4 to ensure correct training and settings.
Voluntary peak cough flow
Assessments will be performed in accordance with American Thoracic Society/European Thoracic Society guidelines.
Assessment of Swallowing
Swallowing will be assessed using a flexible endoscopic evaluation of swallowing (FEES). This is a standardized examination of the swallowing process, which involves transnasal insertion of a flexible endoscope into the pharynx, followed by evaluation of food passage. The assessment will be performed according to established protocols for patients with Parkinson's disease. All FEES examinations will be video-recorded, anonymized, and subsequently independently evaluated by blinded raters in a randomized order.
Assessment of Drooling
Drooling will be assessed using a questionnaire consisting of seven items evaluating the presence and severity of uncontrolled saliva leakage from the mouth in various aspects of daily life in patients with Parkinson's disease.
Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP)
Assessments will be performed in accordance with American Thoracic Society/European Thoracic Society guidelines.
Forced vital capacity (FVC)
Assessments will be performed in accordance with American Thoracic Society/European Thoracic Society guidelines.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
