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

November 25, 2025 updated by: Kateřina Dvořáková, General University Hospital, Prague

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Martin Srp, PhD.
  • Phone Number: +420 224 965 513

Study Locations

  • Czechia
      • Prague, Czechia, 12000
        • General University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week -1, week 0, week 4, week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week -1, week 4, week 8
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.
Week -1, week 4, week 8
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.
Week -1, week 0, week 4, week 8
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.
Week -1, week 0, week 4, week 8
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.
Week -1, week 0, week 4, week 8
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.
Week -1, week 0, week 4, week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

General University Hospital, Prague

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2025

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

November 25, 2025

First Submitted That Met QC Criteria

November 25, 2025

First Posted (Actual)

December 8, 2025

Study Record Updates

Last Update Posted (Actual)

December 8, 2025

Last Update Submitted That Met QC Criteria

November 25, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 45-25 S-IV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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