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

G

General University Hospital, Prague

Status

Enrolling

Conditions

Parkinson Disease

Study type

Observational

Funder types

Other

Identifiers

NCT06955377
16/25 S-IV

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

Patients with Parkinson's disease
Description:
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
Description:
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.

Trial contacts and locations

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Central trial contact

Kateřina Dvořáková, MSc.; Martin Srp, PhD.

Data sourced from clinicaltrials.gov

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