Clinical trial NCT06955377: Effect of Trunk Flexion on Airway Defense in Parkinson's Disease
Official title: Effect of Forward Trunk Flexion in Patients With Parkinson's Disease on the Airway Defense System
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parkinson Disease
Keywords: Parkinson Disease
Postural abnormalities
Airway defense system
Lead sponsor: General University Hospital, Prague
Sponsor class: OTHER
First posted: 2025-05-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Voluntary peak cough flow
timeFrame: baseline, 12months, 24months, 36months
measure: Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP)
timeFrame: baseline, 12months, 24months, 36months
measure: Forced vital capacity (FVC)
timeFrame: baseline, 12months, 24months, 36months
measure: Forced expiratory volume (FEV1)
timeFrame: baseline, 12months, 24months, 36months
measure: Peak expiratory flow (PEF)
timeFrame: baseline, 12months, 24months, 36months
Secondary outcomes:
measure: Hand grip strength
timeFrame: baseline, 12months, 24months, 36months
measure: Index of Pulmonary Dysfunction (IPD)
timeFrame: baseline, 12months, 24months, 36months
Other outcomes:
Locations:
city: Prague
country: Czech Republic
facility: General University Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.