- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07932561
Expiratory Muscle Strength Training for People With Parkinson's Disease
Evaluation of Expiratory Muscle Strength Training in Parkinson's Disease - A Randomized Controlled Trial
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.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Jenny Tegnevi, Doctoral Candidate
- Номер телефона: +46 8 123 563 10
- Электронная почта: jenny.tegnevi@ki.se
Места учебы
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Stockholm County
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Stockholm, Stockholm County, Швеция, 171 77
- Рекрутинг
- Department of Speech and Language Therapy, Danderyd Hospital
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Контакт:
- Jenny Tegnevi, BSc, Doctoral Candidate
- Номер телефона: +46 8 123 563 10
- Электронная почта: jenny.tegnevi@ki.se
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Главный следователь:
- Liza Bergström, Associate Professor, PhD
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Arm A) Intervention; Expiratory Muscle Strength Training (EMST)
Participants will perform Expiratory Muscle Strength Training (EMST) using a CE-marked, calibrated handheld threshold device routinely used in clinical practice. The training protocol consists of 5 sets of 5 breaths per day, 5 days per week, for 5 weeks. Training resistance will be individually adjusted on a weekly basis according to participant performance and established EMST training recommendations. |
Expiratory Muscle Strength Training (EMST) will be performed using a CE-marked, calibrated handheld threshold device that provides a fixed expiratory resistance. Participants will complete 5 sets of 5 forceful expiratory breaths per day, 5 days per week, for 5 weeks. The training load will be individually calibrated and adjusted weekly based on each participant's performance to maintain an appropriate training intensity. The intervention is designed to strengthen expiratory and submental muscles involved in respiration, phonation, speech, and swallowing. |
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Без вмешательства: Arm B) Passive Control Group
Participants assigned to the passive control group will not receive the EMST intervention during the study period. No sham intervention will be provided. Following completion of all study assessments, including the 3-month follow-up, participants will be offered the opportunity to receive the EMST intervention. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Sound Pressure Level/SPL
Временное ограничение: Assessment Time-points: (i) Baseline (two baseline measurements obtained 5 weeks apart), (ii) immediately post-intervention, and (iii) 3-month follow-up.
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Sound pressure level (SPL) will be assessed from audio recordings obtained in a sound-treated studio using calibrated recording equipment. Recordings will be made with a head-mounted omnidirectional microphone positioned at a fixed distance from the mouth. Speech samples will be collected using a Speech Range Profile (SRP), a two-dimensional graphical representation of vocal performance, with fundamental frequency (Hz) on the x-axis and vocal intensity (dB) on the y-axis. Participants will read a standardized text and produce spontaneous speech based on a standardized picture-sequence task. Data will be collected both at habitual speaking loudness and during exposure to white noise (70 dB) presented via headphones. SPL will be quantified in decibels [dB] and analyzed on an interval scale (minimum, maximum, and equivalent continuous sound level [Leq SPL]). Higher SPL values indicate greater vocal intensity. |
Assessment Time-points: (i) Baseline (two baseline measurements obtained 5 weeks apart), (ii) immediately post-intervention, and (iii) 3-month follow-up.
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Maximum Phonation Time (MPT)
Временное ограничение: Assessment Time-p.oints: (i) Baseline (two baseline measurements obtained 5 weeks apart), (ii) immediately post-intervention, and (iii) 3-month follow-up.
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Maximum phonation time (MPT) will be assessed from audio recordings obtained in a sound-treated studio using calibrated recording equipment and a head-mounted omnidirectional microphone positioned at a fixed distance from the mouth. Participants will sustain the vowel /a/ for as long as possible following a maximal inhalation. Three trials will be performed with approximately 15-second intervals between attempts. Data will be collected both at habitual speaking loudness and during exposure to white noise (70 dB) presented via headphones. MPT will be quantified in seconds [s] and analyzed on a ratio scale. The highest value obtained under each condition will be used for analysis. Higher MPT values indicate better phonatory performance, reflecting more efficient respiratory support and vocal fold function, whereas lower values may indicate reduced respiratory support and impaired vocal fold function. |
Assessment Time-p.oints: (i) Baseline (two baseline measurements obtained 5 weeks apart), (ii) immediately post-intervention, and (iii) 3-month follow-up.
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Speech Range
Временное ограничение: Assessment Time-points: (i) Baseline (two baseline measurements obtained 5 weeks apart), (ii) immediately post-intervention, and (iii) 3-month follow-up.
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Speech range (fundamental frequency, F0) will be assessed using a Speech Range Profile (SRP), a two-dimensional graphical representation of vocal performance, with fundamental frequency [Hz] on the x-axis and vocal intensity [dB] on the y-axis. Participants will read a standardized text and produce spontaneous speech based on a standardized picture-sequence task. Data will be collected both at habitual speaking loudness and during exposure to white noise (70 dB) presented via headphones. Speech range will be quantified in Hertz [Hz] and analyzed on a ratio scale (minimum, maximum, mean, modal frequency, and range in semitones). A reduced speech range indicates limited pitch variation and reduced prosodic variation during connected speech. |
Assessment Time-points: (i) Baseline (two baseline measurements obtained 5 weeks apart), (ii) immediately post-intervention, and (iii) 3-month follow-up.
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Phrase length
Временное ограничение: Assessment Time-points: (i) Baseline (two baseline measurements obtained 5 weeks apart), (ii) immediately post-intervention, and (iii) 3-month follow-up.
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Phrase length will be assessed from audio recordings obtained in a sound-treated studio using calibrated recording equipment and a head-mounted omnidirectional microphone positioned at a fixed distance from the mouth. Participants will read a standardized text. Data will be collected both at habitual speaking loudness and during exposure to white noise (70 dB) presented via headphones. Phrase length will be quantified as the mean number of syllables per breath group and analyzed on a ratio scale (mean). Higher values indicate more efficient speech breathing, whereas lower values may indicate reduced speech breathing efficiency. |
Assessment Time-points: (i) Baseline (two baseline measurements obtained 5 weeks apart), (ii) immediately post-intervention, and (iii) 3-month follow-up.
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Maximum Expiratory Pressure (MEP)
Временное ограничение: Assessment Time-points: (i) Baseline (two baseline measurements obtained 5 weeks apart), (ii) immediately post-intervention, and (iii) 3-month follow-up.
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Maximal expiratory pressure (MEP) will be obtained using the MicroRPM respiratory pressure meter. Following a maximal inhalation, participants will exhale as forcefully as possible into the device mouthpiece. To ensure reliable measurements, the procedure will be repeated until three values within 10% of each other have been recorded. MEP will be quantified in cmH₂O and analyzed on a ratio scale. The highest value will be used for analysis. Lower MEP values indicate reduced expiratory muscle strength and impaired respiratory function, whereas higher MEP values indicate greater expiratory muscle strength and better respiratory function. |
Assessment Time-points: (i) Baseline (two baseline measurements obtained 5 weeks apart), (ii) immediately post-intervention, and (iii) 3-month follow-up.
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Swallowing Capacity
Временное ограничение: Assessment Time-points: (i) Baseline (two baseline measurements obtained 5 weeks apart), (ii) immediately post-intervention, and (iii) 3-month follow-up.
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Swallowing capacity will be assessed using the Timed Water Swallow Test. Participants are instructed to drink a glass of still water as quickly and safely as possible without interruption. The time in seconds [s] from initial contact of the water with the lips to completion of the final swallow is recorded. To ensure accurate measurement, participants' mouth and neck regions are video-recorded during the assessment. Swallowing capacity is calculated by subtracting any residual volume from the initial volume and dividing the resulting volume by the recorded time. Swallowing capacity will be quantified in milliliters per second [mL/s] and analyzed on a ratio scale. Lower swallowing capacity values indicate reduced swallowing efficiency and poorer swallowing performance, whereas higher values indicate greater swallowing efficiency and better swallowing performance. |
Assessment Time-points: (i) Baseline (two baseline measurements obtained 5 weeks apart), (ii) immediately post-intervention, and (iii) 3-month follow-up.
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Patient Reported Outcome; Respiratory Functioning
Временное ограничение: Assessment Time-points: (i) Baseline (two baseline measurements obtained 5 weeks apart), (ii) immediately post-intervention, and (iii) 3-month follow-up.
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To assess participants' perceived respiratory functioning and breathing-related disability, the Dyspnea Index (DI) will be used. DI is a patient-reported outcome measure (PROM) designed to assess the severity of upper airway-related dyspnea. It consists of 10 items, each rated on a 5-point Likert scale (0-4), yielding a total score ranging from 0 to 40. Higher scores indicate more severe dyspnea symptoms and a greater impact on daily functioning and quality of life. |
Assessment Time-points: (i) Baseline (two baseline measurements obtained 5 weeks apart), (ii) immediately post-intervention, and (iii) 3-month follow-up.
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Patient Reported Outcome; Voice Functioning
Временное ограничение: Assessment Time-points: (i) Baseline (two baseline measurements obtained 5 weeks apart), (ii) immediately post-intervention, and (iii) 3-month follow-up.
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To assess participants' perceived voice functioning and the impact of voice problems on daily life, the Voice Handicap Index (VHI) will be administered. The VHI is a patient-reported outcome measure that evaluates the functional, physical, and emotional consequences of voice disorders. Higher scores indicate a greater perceived voice-related handicap and poorer voice functioning. |
Assessment Time-points: (i) Baseline (two baseline measurements obtained 5 weeks apart), (ii) immediately post-intervention, and (iii) 3-month follow-up.
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Patient Reported Outcome; Speech and Communication Functioning
Временное ограничение: Assessment Time-points: (i) Baseline (two baseline measurements obtained 5 weeks apart), (ii) immediately post-intervention, and (iii) 3-month follow-up.
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To assess participants' perceived speech functioning and communication-related difficulties, the Self-report Questionnaire on Acquired Speech Difficulties (SOFT) will be administered. The SOFT is a patient-reported outcome measure consisting of items rated on a 4-point Likert scale, yielding a mean score ranging from 0 to 3. Higher scores indicate a greater perceived impact of speech and communication difficulties on daily life. |
Assessment Time-points: (i) Baseline (two baseline measurements obtained 5 weeks apart), (ii) immediately post-intervention, and (iii) 3-month follow-up.
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Patient Reported Outcome; Swallowing Functioning
Временное ограничение: Assessment Time-points: (i) Baseline (two baseline measurements obtained 5 weeks apart), (ii) immediately post-intervention, and (iii) 3-month follow-up.
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To assess participants' perceived swallowing functioning and the impact of swallowing difficulties on daily life, the Sydney Swallow Questionnaire (SSQ) will be administered. The SSQ is a patient-reported outcome measure that assesses self-perceived swallowing difficulties using visual analogue scales, yielding a total score ranging from 0 to 1700. Higher scores indicate greater perceived swallowing impairment and swallowing-related disability. |
Assessment Time-points: (i) Baseline (two baseline measurements obtained 5 weeks apart), (ii) immediately post-intervention, and (iii) 3-month follow-up.
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Dysarthria severity
Временное ограничение: Assessment Time-points: (i) Baseline (two baseline measurements obtained 5 weeks apart), (ii) immediately post-intervention, and (iii) 3-month follow-up.
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The participant's level of functioning will be evaluated within the framework of the International Classification of Functioning, Disability and Health (ICF) using validated Therapy Outcome Measures (TOM). Likert scale, score range 0-5. Higher scores indicate better functioning, participation, and well-being, as well as reduced disability related to dysarthria. |
Assessment Time-points: (i) Baseline (two baseline measurements obtained 5 weeks apart), (ii) immediately post-intervention, and (iii) 3-month follow-up.
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Dysphagia severity
Временное ограничение: Assessment Time-points: (i) Baseline (two baseline measurements obtained 5 weeks apart), (ii) immediately post-intervention, and (iii) 3-month follow-up.
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The participant's level of functioning will be evaluated within the framework of the International Classification of Functioning, Disability and Health (ICF) using validated Therapy Outcome Measures (TOM). The participant's level of functioning will be evaluated within the framework of the International Classification of Functioning, Disability and Health (ICF) using validated Therapy Outcome Measures (TOM). Likert scale, score range 0-5. Higher scores indicate better functioning, participation, and well-being, as well as reduced disability related to dysphagia. |
Assessment Time-points: (i) Baseline (two baseline measurements obtained 5 weeks apart), (ii) immediately post-intervention, and (iii) 3-month follow-up.
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Functional oral intake
Временное ограничение: Assessment Time-points: (i) Baseline (two baseline measurements obtained 5 weeks apart), (ii) immediately post-intervention, and (iii) 3-month follow-up.
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Measured using the International Dysphagia Diet Standardisation Initiative Functional Diet Scale (IDDSI-FDS). Ordinal scale, score range 0-7. Higher scores indicate better swallowing-related dietary function and fewer dietary restrictions. |
Assessment Time-points: (i) Baseline (two baseline measurements obtained 5 weeks apart), (ii) immediately post-intervention, and (iii) 3-month follow-up.
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Соавторы и исследователи
Спонсор
Соавторы
Следователи
- Главный следователь: Liza Bergström, Associate Professor, PhD, Karolinska Institutet Danderyd Hospital
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Синуклеинопатии
- Неврологические проявления
- Заболевания головного мозга
- Заболевания центральной нервной системы
- Заболевания нервной системы
- Патологические процессы
- Заболевания дыхательных путей
- Заболевания пищеварительной системы
- Желудочно-кишечные заболевания
- Нейроповеденческие проявления
- Нарушения дыхания
- Нейродегенеративные заболевания
- Заболевания пищевода
- Оториноларингологические заболевания
- Двигательные расстройства
- Заболевания глотки
- Паркинсонические расстройства
- Заболевания базальных ганглиев
- Коммуникативные расстройства
- Языковые расстройства
- Расстройства речи
- Расстройства артикуляции
- Патологические состояния, признаки и симптомы
- Признаки и симптомы
- Респираторная аспирация
- Болезнь Паркинсона
- Расстройства глотания
- Дизартрия
Другие идентификационные номера исследования
- 2023-04536-01
- 2023 (Грант/контракт NIH США)
- Approval Number 2023-04536-01 (Другой идентификатор: Swedish Ethical Review Authority)
- Approval Number 5.1-2024-16540 (Другой идентификатор: Swedish Medical Products Agency)
Планирование данных отдельных участников (IPD)
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Описание плана IPD
The datasets generated and/or analysed during the current study will not be stored on an external site, however will be available from the corresponding author upon reasonable request.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .