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

NCT ID: NCT06955377

Last Updated: 2025-05-02

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

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-18

Study Completion Date

2029-02-28

Brief Summary

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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.

Detailed Description

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The primary aim of the study will be to verify the potential relationship between forward trunk flexion, respiratory muscle strength, and the strength of voluntary cough.

Hypotheses:

1. Forward trunk flexion in patients with Parkinson's disease (PD) will negatively affect respiratory muscle strength and the strength of voluntary cough.
2. Respiratory muscle strength and the strength of voluntary cough will deteriorate more rapidly over a three-year period in patients with PD and forward trunk flexion than in patients with PD without forward trunk flexion.

The secondary aim will be to correlate respiratory muscle strength and the strength of voluntary cough with handgrip strength and the pulmonary dysfunction index as potential screening methods.

Hypothesis:

1\. Handgrip strength and the pulmonary dysfunction index will correlate with respiratory muscle strength and the strength of voluntary cough.

Conditions

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Parkinson Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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General University Hospital, Prague

OTHER

Sponsor Role lead

Responsible Party

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Kateřina Dvořáková

Physiotherapist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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General University Hospital

Prague, , Czechia

Site Status RECRUITING

Countries

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Czechia

Central Contacts

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Kateřina Dvořáková, MSc.

Role: CONTACT

+420 224 965 513

Martin Srp, PhD.

Role: CONTACT

+420224965513

Facility Contacts

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Kateřina Dvořáková, MSc.

Role: primary

+420 224 965 513

References

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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.

Reference Type BACKGROUND
PMID: 30830153 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30363363 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31538092 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33650729 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36345090 (View on PubMed)

Other Identifiers

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16/25 S-IV

Identifier Type: -

Identifier Source: org_study_id

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