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NCT Number: NCT06955377

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

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

General University Hospital

Prague, 12000, Czechia

Location status: Recruiting

Location contact

Kateřina Dvořáková, MSc.

CONTACT

[email protected]

+420 224 965 513

About this study

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:

  • Forward trunk flexion in patients with Parkinson's disease (PD) will negatively affect respiratory muscle strength and the strength of voluntary cough.
  • 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:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Voluntary peak cough flow

    Time frame: baseline, 12months, 24months, 36months

    Assessments will be performed in accordance with American Thoracic Society/European Thoracic Society guidelines.

  2. Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP)

    Time frame: baseline, 12months, 24months, 36months

    Assessments will be performed in accordance with American Thoracic Society/European Thoracic Society guidelines.

  3. Forced vital capacity (FVC)

    Time frame: baseline, 12months, 24months, 36months

    Assessments will be performed in accordance with American Thoracic Society/European Thoracic Society guidelines.

  4. Forced expiratory volume (FEV1)

    Time frame: baseline, 12months, 24months, 36months

    Assessments will be performed in accordance with American Thoracic Society/European Thoracic Society guidelines.

  5. Peak expiratory flow (PEF)

    Time frame: baseline, 12months, 24months, 36months

    Assessments will be performed in accordance with American Thoracic Society/European Thoracic Society guidelines.

Secondary outcomes

  1. Hand grip strength

    Time frame: baseline, 12months, 24months, 36months

    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.

  2. Index of Pulmonary Dysfunction (IPD)

    Time frame: baseline, 12months, 24months, 36months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kateřina Dvořáková, MSc.

CONTACT

[email protected]

+420 224 965 513

Martin Srp, PhD.

CONTACT

+420224965513

Sponsors and collaborators

Lead sponsor

General University Hospital, Prague

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
May 2, 2025
Registry last updated
May 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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