Effect of Trunk Flexion on Airway Defense in Parkinson's Disease

NCT06955377 | Recruiting

• 1 other identifier: 16/25 S-IV
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The main mechanisms of airway protection include a properly functioning swallowing process and a cough. Studies focusing on patients with Parkinson's disease (PD) have previously demonstrated impairments in both swallowing (dysphagia) and coughing (dystussia). Aspiration pneumonia is the leading cause of death in individuals with PD. Swallowing function is directly related to body posture. Postural abnormalities (PA) are a common symptom of PD and significantly contribute to patient disability, affect respiratory function, and reduce quality of life. Previous research has shown that more than 20% of PD patients suffer from some form of PA. Most PD patients with a forward trunk flexion angle greater than 30 degrees report specific difficulties, such as dysphagia. A link has previously been demonstrated between postural abnormalities associated with flexed posture and restrictive ventilatory impairment. It can be assumed that this restrictive ventilatory impairment, which reduces the amount of air the patient can inhale into the lungs and subsequently exhale, negatively affects the strength of voluntary cough. However, this hypothesis has not yet been verified in the mentioned patient group. The primary aim of the study will be to examine the effect of forward trunk flexion (FTF) in Parkinson's disease on the airway defense system.

Conditions

Parkinson Disease

Keywords

Parkinson Disease; Postural abnormalities; Airway defense system

Outcome Measures

Primary Outcomes (5)

• Voluntary peak cough flow

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

  baseline, 12months, 24months, 36months

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

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

  baseline, 12months, 24months, 36months

• Forced vital capacity (FVC)

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

  baseline, 12months, 24months, 36months

• Forced expiratory volume (FEV1)

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

  baseline, 12months, 24months, 36months

• Peak expiratory flow (PEF)

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

  baseline, 12months, 24months, 36months

Secondary Outcomes (2)

• Hand grip strength

  baseline, 12months, 24months, 36months

• Index of Pulmonary Dysfunction (IPD)

  baseline, 12months, 24months, 36months

Study Arms (2)

Patients with Parkinson's disease

Participants of both groups will attend a total of five visits. During each visit, the participants will undergo a complete assessment including respiratory muscle strength, cough strength, dynamic spirometry, grip strength via a digital hand dynamometer, and evaluation of pulmonary dysfunction using the Index of Pulmonary Dysfunction (IPD) questionnaire. Each examination will last approximately 20 minutes, with no specific training or additional procedures required between visits.

Patients with Parkinson's disease and forward trunk flexion

Patients with pathological forward trunk flexion defined as thoracic (≥25°) or lumbar flexion (\>15°) in standing and walking, which completely disappears in the supine position. Participants of both groups will attend a total of five visits. During each visit, the participants will undergo a complete assessment including respiratory muscle strength, cough strength, dynamic spirometry, grip strength via a digital hand dynamometer, and evaluation of pulmonary dysfunction using the Index of Pulmonary Dysfunction (IPD) questionnaire. Each examination will last approximately 20 minutes, with no specific training or additional procedures required between visits.

Eligibility Criteria

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

Study Population

For this study, participants will be selected from patients with Parkinson's Disease who are being monitored at the Extrapyramidal Center of the Neurology Clinic and the Center for Clinical Neuroscience at the First Faculty of Medicine, Charles University, and the General University Hospital in Prague.

You may qualify if:

• Diagnosis of Parkinson' s disease
• Age ≥ 18 years

You may not qualify if:

• Unreliable performance of MIP, MEP, or grip strength measurements, for example, due to cognitive deficits (assessed by the researcher)
• Inadequate lip seal
• Significant deformities of the dominant hand that could affect the accuracy of grip strength measurements
• Other severe neurological diseases apart from PD
• History of unstable cardiovascular disease
• Severe pulmonary disease

Sponsors & Collaborators

• General University Hospital, Prague: lead

Study Sites (1)

General University Hospital

Prague, 12000, Czechia

RECRUITING

Related Publications (5)

• 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

• 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

• 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

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

+420224965513

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: May 2, 2025
• Study Start: February 18, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: May 2, 2025

Record last verified: 2025-04

Locations

CZ (1)