Effect of Trunk Flexion on Airway Defense in Parkinson's Disease
ConditionParkinson Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGeneral University Hospital, Prague
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of Parkinson' s disease
Age ≥ 18 years
Disqualifiers
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
Trial 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.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 2 trial groupsGroup A: Patients with Parkinson's disease
Group B: Patients with Parkinson's disease and forward trunk flexion
Trial outcomes
Primary outcomes
1
Voluntary peak cough flow
Assessments will be performed in accordance with American Thoracic Society/European Thoracic Society guidelines.
Time frame
baseline, 12months, 24months, 36months2
Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP)
Assessments will be performed in accordance with American Thoracic Society/European Thoracic Society guidelines.
Time frame
baseline, 12months, 24months, 36months3
Forced vital capacity (FVC)
Assessments will be performed in accordance with American Thoracic Society/European Thoracic Society guidelines.
Time frame
baseline, 12months, 24months, 36months4
Forced expiratory volume (FEV1)
Assessments will be performed in accordance with American Thoracic Society/European Thoracic Society guidelines.
Time frame
baseline, 12months, 24months, 36monthsSecondary outcomes
1
Hand grip strength
The 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.
Time frame
baseline, 12months, 24months, 36months2
Index of Pulmonary Dysfunction (IPD)
The 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.
Time frame
baseline, 12months, 24months, 36monthsSponsors and contacts
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Source ClinicalTrials.gov