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

NCT07268703 | Not Yet Recruiting

• 1 other identifier: 45-25 S-IV
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson's Disease

Keywords

Parkinson's Disease; Expiratory Muscle Strength Training; Forward Trunk Flexion

Outcome Measures

Primary Outcomes (1)

• Voluntary peak cough flow

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

  Week -1, week 0, week 4, week 8

Secondary Outcomes (6)

• Assessment of Swallowing

  Week -1, week 4, week 8

• Assessment of Drooling

  Week -1, week 4, week 8

• Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP)

  Week -1, week 0, week 4, week 8

• Forced vital capacity (FVC)

  Week -1, week 0, week 4, week 8

• Forced expiratory volume (FEV1)

  Week -1, week 0, week 4, week 8

Study Arms (2)

PD with Forward Trunk Flexion

EXPERIMENTAL

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

PD without Forward Trunk Flexion

ACTIVE COMPARATOR

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

Interventions

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.

PD with Forward Trunk Flexion; PD without Forward Trunk Flexion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• General University Hospital, Prague: lead

Study Sites (1)

General University Hospital

Prague, 12000, Czechia

Location

Related Publications (9)

• Laveneziana P, Albuquerque A, Aliverti A, Babb T, Barreiro E, Dres M, Dube BP, Fauroux B, Gea J, Guenette JA, Hudson AL, Kabitz HJ, Laghi F, Langer D, Luo YM, Neder JA, O'Donnell D, Polkey MI, Rabinovich RA, Rossi A, Series F, Similowski T, Spengler CM, Vogiatzis I, Verges S. ERS statement on respiratory muscle testing at rest and during exercise. Eur Respir J. 2019 Jun 13;53(6):1801214. doi: 10.1183/13993003.01214-2018. Print 2019 Jun.

  PMID: 30956204 BACKGROUND

• Tinazzi M, Geroin C, Bhidayasiri R, Bloem BR, Capato T, Djaldetti R, Doherty K, Fasano A, Tibar H, Lopiano L, Margraf NG, Merello M, Moreau C, Ugawa Y, Artusi CA; International Parkinson and Movement Disorders Society Task Force on Postural Abnormalities. Task Force Consensus on Nosology and Cut-Off Values for Axial Postural Abnormalities in Parkinsonism. Mov Disord Clin Pract. 2022 May 9;9(5):594-603. doi: 10.1002/mdc3.13460. eCollection 2022 Jul.

  PMID: 35844289 BACKGROUND

• Forsyth AL, Joshi RY, Canning CG, Allen NE, Paul SS. Flexed Posture in Parkinson Disease: Associations With Nonmotor Impairments and Activity Limitations. Phys Ther. 2019 Jul 1;99(7):893-903. doi: 10.1093/ptj/pzz033.

  PMID: 30830153 BACKGROUND

• Troche MS, Rosenbek JC, Okun MS, Sapienza CM. Detraining outcomes with expiratory muscle strength training in Parkinson disease. J Rehabil Res Dev. 2014;51(2):305-10. doi: 10.1682/JRRD.2013.05.0101.

  PMID: 24933728 BACKGROUND

• Cocks N, Rafols J, Embley E, Hill K. Expiratory Muscle Strength Training for Drooling in Adults with Parkinson's Disease. Dysphagia. 2022 Dec;37(6):1525-1531. doi: 10.1007/s00455-022-10408-6. Epub 2022 Feb 16.

  PMID: 35171321 BACKGROUND

• Claus I, Muhle P, Czechowski J, Ahring S, Labeit B, Suntrup-Krueger S, Wiendl H, Dziewas R, Warnecke T. Expiratory Muscle Strength Training for Therapy of Pharyngeal Dysphagia in Parkinson's Disease. Mov Disord. 2021 Aug;36(8):1815-1824. doi: 10.1002/mds.28552. Epub 2021 Mar 2.

  PMID: 33650729 BACKGROUND

• Troche MS, Curtis JA, Sevitz JS, Dakin AE, Perry SE, Borders JC, Grande AA, Mou Y, Vanegas-Arroyave N, Hegland KW. Rehabilitating Cough Dysfunction in Parkinson's Disease: A Randomized Controlled Trial. Mov Disord. 2023 Feb;38(2):201-211. doi: 10.1002/mds.29268. Epub 2022 Nov 7.

  PMID: 36345090 BACKGROUND

• Margraf NG, Granert O, Hampel J, Wrede A, Schulz-Schaeffer WJ, Deuschl G. Clinical Definition of Camptocormia in Parkinson's Disease. Mov Disord Clin Pract. 2016 Oct 11;4(3):349-357. doi: 10.1002/mdc3.12437. eCollection 2017 May-Jun.

  PMID: 30363363 BACKGROUND

• Tinazzi M, Gandolfi M, Ceravolo R, Capecci M, Andrenelli E, Ceravolo MG, Bonanni L, Onofrj M, Vitale M, Catalan M, Polverino P, Bertolotti C, Mazzucchi S, Giannoni S, Smania N, Tamburin S, Vacca L, Stocchi F, Radicati FG, Artusi CA, Zibetti M, Lopiano L, Fasano A, Geroin C. Postural Abnormalities in Parkinson's Disease: An Epidemiological and Clinical Multicenter Study. Mov Disord Clin Pract. 2019 Jun 29;6(7):576-585. doi: 10.1002/mdc3.12810. eCollection 2019 Sep.

  PMID: 31538092 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Central Study Contacts

Kateřina Dvořáková, MSc.

CONTACT

+420 224 965 513; katerina.dvorakova@vfn.cz

Martin Srp, PhD.

CONTACT

+420 224 965 513

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 8, 2025
• Study Start: December 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: May 1, 2026
• Last Updated: December 8, 2025

Record last verified: 2025-11

Locations

CZ (1)