An interventional study of Expiratory muscle strength training in Parkinson's Disease, sponsored by General University Hospital, Prague. Not yet recruiting at 1 site in Czechia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-08.
Sponsored by General University Hospital, Prague · Not applicable, Interventional, and Treatment
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.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's planned enrollment of 28 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →General University Hospital, Prague is the lead sponsor of 37 studies on the registry; 23 are open to participants now.
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Exclusion Criteria:
Participants in this arm have Parkinson's disease and forward trunk flexion, defined as thoracic flexion ≥25° or lumbar flexion ≥15° while standing and walking, which completely disappears when lying down. They will follow the study schedule including all assessments and the 4-week EMST program. Outcomes will include voluntary peak cough flow, respiratory muscle strength, swallowing function (FEES), drooling, and posture assessment using standardized photographs.
Device: Expiratory muscle strength training
Participants in this arm have Parkinson's disease without forward trunk flexion (no postural abnormalities). They will follow the same study schedule including all assessments and the 4-week EMST program as the experimental group.
Device: Expiratory muscle strength training
Participants 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.
Time frame: Week -1, week 0, week 4, week 8
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.
Time frame: Week -1, week 4, week 8
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.
Time frame: Week -1, week 4, week 8
Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP)
Assessments will be performed in accordance with American Thoracic Society/European Thoracic Society guidelines.
Time frame: Week -1, week 0, week 4, week 8
Forced vital capacity (FVC)
Assessments will be performed in accordance with American Thoracic Society/European Thoracic Society guidelines.
Time frame: Week -1, week 0, week 4, week 8
Forced expiratory volume (FEV1)
Assessments will be performed in accordance with American Thoracic Society/European Thoracic Society guidelines.
Time frame: Week -1, week 0, week 4, week 8
Peak expiratory flow (PEF)
Assessments will be performed in accordance with American Thoracic Society/European Thoracic Society guidelines.
Time frame: Week -1, week 0, week 4, week 8
Plan to share: Undecided
This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
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General University Hospital, Prague