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临床试验/NCT06955377
NCT06955377招募中不适用

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

General University Hospital, Prague1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年2月18日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Voluntary peak cough flow

研究概览

简要总结

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.

详细描述

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:

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Diagnosis of Parkinson' s disease
  • •Age ≥ 18 years

排除标准

  • •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

结局指标

主要结局

Voluntary peak cough flow

时间窗: baseline, 12months, 24months, 36months

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

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

时间窗: baseline, 12months, 24months, 36months

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

Forced vital capacity (FVC)

时间窗: baseline, 12months, 24months, 36months

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

Forced expiratory volume (FEV1)

时间窗: baseline, 12months, 24months, 36months

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

Peak expiratory flow (PEF)

时间窗: baseline, 12months, 24months, 36months

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

次要结局

  • Hand grip strength(baseline, 12months, 24months, 36months)
  • Index of Pulmonary Dysfunction (IPD)(baseline, 12months, 24months, 36months)

研究者

发起方
General University Hospital, Prague
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kateřina Dvořáková

Physiotherapist

General University Hospital, Prague

研究点 (1)

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