Expiratory Muscle Training in Parkinson's Disease With Forward Trunk Flexion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2026-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Parkinson's Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PD with Forward Trunk Flexion

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.

Group Type EXPERIMENTAL

Expiratory muscle strength training

Intervention Type DEVICE

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.

PD without Forward Trunk Flexion

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.

Group Type ACTIVE_COMPARATOR

Expiratory muscle strength training

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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
* Pathological forward trunk flexion defined as thoracic (≥ 25°) or lumbar flexion (\> 15°) during standing and walking, which completely disappears in the supine position (for the experimental group only)

Exclusion Criteria

* 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
* Inadequate lip seal

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No