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Expiratory Muscle Training in Parkinson's Disease With Forward Trunk Flexion

G

General University Hospital, Prague

Status

Not yet enrolling

Conditions

Parkinson's Disease

Treatments

Device: Expiratory muscle strength training

Study type

Interventional

Funder types

Other

Identifiers

NCT07268703
45-25 S-IV

Details and patient eligibility

About

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.

Enrollment

28 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

28 participants in 2 patient groups

PD with Forward Trunk Flexion
Experimental group
Description:
Participants in this arm have Parkinson's disease and forward trunk flexion, defined as thoracic flexion ≥25° or lumbar flexion ≥15° while standing and walking, which completely disappears when lying down. They will follow the study schedule including all assessments and the 4-week EMST program. Outcomes will include voluntary peak cough flow, respiratory muscle strength, swallowing function (FEES), drooling, and posture assessment using standardized photographs.
Treatment:
Device: Expiratory muscle strength training
PD without Forward Trunk Flexion
Active Comparator group
Description:
Participants in this arm have Parkinson's disease without forward trunk flexion (no postural abnormalities). They will follow the same study schedule including all assessments and the 4-week EMST program as the experimental group.
Treatment:
Device: Expiratory muscle strength training

Trial contacts and locations

1

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Central trial contact

Martin Srp, PhD.; Kateřina Dvořáková, MSc.

Data sourced from clinicaltrials.gov

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