Overview
This study is a Post-Market Clinical Follow-up (PMCF) randomized controlled trial of a CE-marked device used in routine clinical practice. The goal of this study is to investigate whether Expiratory Muscle Strength Training (EMST) improves voice, speech, breathing, and swallowing function in people with Parkinson's disease.
The research questions are:
Does EMST improve voice, speech, breathing, and swallowing in people with Parkinson's disease, as measured by clinical tests, immediately after the training period and three months later? Does EMST lead to meaningful improvements in voice, speech, breathing, and swallowing problems as reported by people with Parkinson's disease immediately after the training period and three months later? Do the effects of EMST differ according to disease severity?
Researchers will compare participants who receive EMST with participants in a passive control group to determine whether EMST improves voice, speech, breathing, and swallowing function.
Participants will:
Be randomly assigned to either an EMST group or a passive control group. Complete a structured EMST training program, if assigned to the intervention group.
Attend study visits for assessments of voice, speech, breathing, and swallowing function.
Undergo clinical tests and complete study-related evaluations throughout the study.
Be monitored for any device-related or study-related adverse events.
Description
Parkinson's disease (PD) is associated with impairments in respiratory, phonatory, speech, and swallowing functions that can negatively affect communication, nutritional status, and quality of life. Expiratory Muscle Strength Training (EMST) is a device-based intervention that targets expiratory and submental muscle strength and has shown potential benefits for respiratory function, swallowing safety, and vocal performance in individuals with PD.
This study is designed as a prospective, single-blind, randomized controlled trial with two parallel study arms: (A) an intervention group receiving EMST and (B) a passive control group. The aim of the study is to investigate the effects of EMST on respiratory, phonatory, speech, and swallowing functions in individuals with PD. Participants assigned to the intervention group will complete a 5-week EMST training program. Assessments will be conducted at baseline, immediately following the training period, and after a 3-month detraining period to evaluate both short- and long-term effects of the intervention.
Note: This study was registered retrospectively due to an administrative oversight. The Clinical Investigation Plan (CIP), including all intervention procedures and outcome measures, was finalized and locked prior to participant enrollment. The CIP was approved by the Swedish Medical Products Agency on 2024-02-18 (CIV-ID; CIV-23-12-045455, approval number 5.1-2024-16540) and has remained unchanged since study initiation.
Eligibility
Inclusion Criteria:
- Confirmed diagnosis of Parkinson's disease
- Stable medication
- Cognitive function corresponding to a score of ≥23 on the Mini-Mental State Examination (MMSE)
Exclusion Criteria:
- Untreated hypertension
- Untreated gastroesophageal reflux disease
- Asthma, chronic obstructive pulmonary disease (COPD), or other pulmonary disease.
- Current smoking or smoking within the past 12 months prior to enrollment
