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NCT Number: NCT07268703

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

General University Hospital

Prague, 12000, Czechia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Expiratory muscle strength training

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.

Primary outcomes

  1. Voluntary peak cough flow

    Time frame: Week -1, week 0, week 4, week 8

    Assessments will be performed in accordance with American Thoracic Society/European Thoracic Society guidelines.

Secondary outcomes

  1. Assessment of Swallowing

    Time frame: Week -1, week 4, week 8

    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.

  2. Assessment of Drooling

    Time frame: Week -1, week 4, week 8

    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.

  3. Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP)

    Time frame: Week -1, week 0, week 4, week 8

    Assessments will be performed in accordance with American Thoracic Society/European Thoracic Society guidelines.

  4. Forced vital capacity (FVC)

    Time frame: Week -1, week 0, week 4, week 8

    Assessments will be performed in accordance with American Thoracic Society/European Thoracic Society guidelines.

  5. Forced expiratory volume (FEV1)

    Time frame: Week -1, week 0, week 4, week 8

    Assessments will be performed in accordance with American Thoracic Society/European Thoracic Society guidelines.

  6. Peak expiratory flow (PEF)

    Time frame: Week -1, week 0, week 4, week 8

    Assessments will be performed in accordance with American Thoracic Society/European Thoracic Society guidelines.

Study contacts

Contact information is provided by the study sponsor or research team.

Kateřina Dvořáková, MSc.

CONTACT

[email protected]

+420 224 965 513

Martin Srp, PhD.

CONTACT

+420 224 965 513

Sponsors and collaborators

Lead sponsor

General University Hospital, Prague

Other

Registry information

Official study title

Effect of Expiratory Muscle Strength Training in Patients With Parkinson's Disease and Forward Trunk Flexion: A Pilot Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 8, 2025
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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