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临床试验/NCT07268703
NCT07268703尚未招募不适用

Effect of Expiratory Muscle Strength Training in Patients With Parkinson's Disease and Forward Trunk Flexion: A Pilot Study

General University Hospital, Prague2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2025年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
28
试验地点
2
主要终点
Voluntary peak cough flow

研究概览

简要总结

Postural abnormalities (PA) negatively affecting the axial system are part of the symptoms of Parkinson's disease (PD). They occur in more than 20% of patients with PD especially in more advanced stages of the disease, contribute significantly to patient disability, affect respiratory functions, and reduce quality of life. Eighty-five percent of patients with forward trunk flexion (FTF) reported difficulties with swallowing (dysphagia), shortness of breath, and drooling. Previous studies in patients with PD also identified cough disorders (dystussia). Since cough and properly functioning swallowing are key mechanisms for airway protection, impairments in these functions lead to a higher risk of aspiration. The seriousness of this problem is clearly confirmed by the fact that aspiration pneumonia is the leading cause of death in patients with PD.

Among non-pharmacological interventions for airway protection, expiratory muscle strength training (EMST) has been shown to be beneficial in patients with PD. Recent randomized controlled studies demonstrated a significant effect of EMST on dysphagia, dystussia, drooling, and dysarthria in patients with PD.

However, the literature lacks data on the effect of EMST on dystussia in patients with PD and FTF, who, according to previous research, are also affected by restrictive ventilatory impairment, which negatively affects respiratory capacity and, in particular, cough strength.

The aim of this study is to evaluate the effect of EMST on cough, swallowing, respiratory muscle strength, and drooling in patients with PD and forward trunk flexion.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Diagnosis of Parkinson' s disease
  • Age ≥ 18 years
  • MoCA score (Montreal Cognitive Assessment) ≥ 19
  • Score II-IV during the "ON" phase under regular antiparkinsonian medication according to the Modified Hoehn and Yahr Scale
  • Pathological forward trunk flexion defined as thoracic (≥ 25°) or lumbar flexion (> 15°) during standing and walking, which completely disappears in the supine position (for the experimental group only)

排除标准

  • Change in antiparkinsonian medication within the last 3 months prior to study enrollment
  • Other neurological, orthopedic, cardiovascular, or respiratory comorbidities
  • Inability to cooperate due to neuropsychological dysfunction
  • Current smoking history
  • Inadequate lip seal

结局指标

主要结局

Voluntary peak cough flow

时间窗: Week -1, week 0, week 4, week 8

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

次要结局

  • Assessment of Drooling(Week -1, week 4, week 8)
  • Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP)(Week -1, week 0, week 4, week 8)
  • Forced expiratory volume (FEV1)(Week -1, week 0, week 4, week 8)
  • Forced vital capacity (FVC)(Week -1, week 0, week 4, week 8)
  • Peak expiratory flow (PEF)(Week -1, week 0, week 4, week 8)
  • Assessment of Swallowing(Week -1, week 4, week 8)

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 (2)

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