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

Effect of Forward Trunk Flexion in Patients With Parkinson's Disease on the Airway Defense System

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06955377
Enrollment
100
Registered
2025-05-02
Start date
2025-02-18
Completion date
2029-02-28
Last updated
2025-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Keywords

Parkinson Disease, Postural abnormalities, Airway defense system

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.

Interventions

None listed

Sponsors

General University Hospital, Prague
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Peak expiratory flow (PEF)baseline, 12months, 24months, 36monthsAssessments will be performed in accordance with American Thoracic Society/European Thoracic Society guidelines.
Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP)baseline, 12months, 24months, 36monthsAssessments will be performed in accordance with American Thoracic Society/European Thoracic Society guidelines.
Forced vital capacity (FVC)baseline, 12months, 24months, 36monthsAssessments will be performed in accordance with American Thoracic Society/European Thoracic Society guidelines.
Forced expiratory volume (FEV1)baseline, 12months, 24months, 36monthsAssessments will be performed in accordance with American Thoracic Society/European Thoracic Society guidelines.
Voluntary peak cough flowbaseline, 12months, 24months, 36monthsAssessments will be performed in accordance with American Thoracic Society/European Thoracic Society guidelines.

Secondary

MeasureTime frameDescription
Index of Pulmonary Dysfunction (IPD)baseline, 12months, 24months, 36monthsThe screening assessment using the IPD questionnaire will involve the evaluation of four clinical indicators. The first two are direct questions asked to the patient regarding mucus management and cough strength. The third item is the strength of the voluntarily induced cough, subjectively assessed by the examiner. The fourth item tests the patient's ability to count out loud for as long as possible after a maximum inspiratory effort.
Hand grip strengthbaseline, 12months, 24months, 36monthsThe assessment of hand grip strength will be conducted according to the recommendations of the American Society of Hand Therapists. A digital hand dynamometer will be used.

Countries

Czechia

Contacts

Primary ContactKateřina Dvořáková, MSc.
katerina.dvorakova@vfn.cz+420 224 965 513
Backup ContactMartin Srp, PhD.
+420224965513

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026