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Набор скоро начнётся NCT06473428

Investigating Muscle Training's Respiratory Outcomes and Voice Enhancement in Parkinson's Disease

Без фазы С лечением Parkinson Disease Pulmonary Disease Voice Disorders

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: respiratory muscle training, Expiratory Muscle Training, Placebo-Controlled Expiratory Muscle Training.
Кому может быть актуально
Состояния в реестре: Parkinson Disease, Pulmonary Disease, Voice Disorders. Базовые параметры: 30 лет — 85 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

The Association of Pulmonary Function, Diaphragm Thickness and Excursion, and Phonatory Measures in Parkinson's Disease

Обзор

This study aims to investigate the effects of different types of respiratory muscle training on lung function, diaphragm movement, and voice quality in patients with Parkinson's disease (PD). PD often leads to breathing difficulties and voice abnormalities due to weakened respiratory muscles and reduced diaphragm mobility. The study will involve 45 participants with PD, randomly assigned to three groups: one group will perform inspiratory muscle training, the second group will perform both inspiratory and expiratory muscle training, and the third group will receive placebo-controlled expiratory muscle training. The hypothesis is that targeted respiratory muscle training will significantly improve pulmonary function, diaphragm excursion, and phonatory measures compared to the placebo group. The findings aim to develop effective rehabilitation strategies to enhance the quality of life and communication abilities in individuals with PD.

Подробное описание

This study aims to investigate the effects of respiratory muscle training on pulmonary function, diaphragm excursion, and phonatory measures in patients with Parkinson's disease (PD). PD often leads to weakened respiratory muscles, reduced diaphragm movement, and voice abnormalities, impacting breathing and communication. The study will recruit 45 patients with PD, who will be randomly assigned to three groups: an inspiratory muscle training group, a combined inspiratory and expiratory muscle training group, and a placebo-controlled expiratory muscle training group. Over eight weeks, participants will perform daily training sessions, with the intensity of the exercises adjusted periodically. Assessments will include pulmonary function tests, ultrasound measurements of diaphragm thickness and movement, and various phonatory evaluations. The hypothesis is that respiratory muscle training will significantly improve respiratory and phonatory functions in PD patients compared to placebo, providing insights into effective rehabilitation strategies for enhancing their quality of life and communication abilities.

Вмешательства

  • Поведенческое respiratory muscle training
    Inspiratory muscle training with two sessions per day, five repetitions per session, six days a week for eight weeks.
  • Поведенческое Expiratory Muscle Training
    Expiratory muscle training with two sessions per day, five repetitions per session, six days a week for eight weeks.
  • Поведенческое Placebo-Controlled Expiratory Muscle Training
    Placebo-controlled expiratory muscle training with two sessions per day, five repetitions per session, six days a week for eight weeks.

Первичные конечные точки

  • Forced Vital Capacity (FVC) [Срок оценки: Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).]
  • Forced Expiratory Volume in One Second (FEV1) [Срок оценки: Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).]
  • Maximal Inspiratory Pressure (MIP) [Срок оценки: Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).]
  • Maximal Expiratory Pressure (MEP) [Срок оценки: Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).]
  • Peak Expiratory Flow Rate (PEFR) [Срок оценки: Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).]
  • Maximum Phonation Time [Срок оценки: Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).]
  • Voice Intensity [Срок оценки: Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).]
  • Speech Rate [Срок оценки: Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).]
  • Speech Pauses [Срок оценки: Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).]
  • Voice Loudness [Срок оценки: Assessments will be conducted at baseline (week 0) and after the intervention period (week 8).]
Вторичные конечные точки (2)
  • Diaphragm Thickness [Срок оценки: Measurements will be taken at baseline (week 0) and after the intervention period (week 8).]
  • Diaphragm Excursion [Срок оценки: Measurements will be taken at baseline (week 0) and after the intervention period (week 8).]

Критерии участия

Критерии включения

  • Patients with Parkinson's disease (Hoehn \& Yahr stage I-III),
  • Patients aged 30-85
  • Patients with stable medical condition, regular medication adherence, and ability to follow instructions.

Критерии исключения

  • Patients with cognitive impairment
  • Patients with respiratory or other neurological diseases
  • Patients with smoking history
  • Patients with respiratory complications
  • Patients with recent chest/abdominal surgery
  • Patients with clinical instability
  • Patients who are unable to perform pulmonary function tests correctly

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

  • Dashtipour K, Tafreshi A, Lee J, Crawley B. Speech disorders in Parkinson's disease: pathophysiology, medical management and surgical approaches. Neurodegener Dis Manag. 2018 Oct;8(5):337-348. doi: 10.2217/nmt-2018-0021. Epub 2018 Sep 18. PMID 30223711
  • Santos RBD, Fraga AS, Coriolano MDGWS, Tiburtino BF, Lins OG, Esteves ACF, Asano NMJ. Respiratory muscle strength and lung function in the stages of Parkinson's disease. J Bras Pneumol. 2019 Sep 30;45(6):e20180148. doi: 10.1590/1806-3713/e20180148. eCollection 2019. PMID 31576908
  • Castillo A, Castillo J, Reyes A. Association Between Subglottic Pressure and Pulmonary Function in Individuals With Parkinson's Disease. J Voice. 2020 Sep;34(5):732-737. doi: 10.1016/j.jvoice.2019.03.001. Epub 2019 Apr 16. PMID 31000398
  • Reyes A, Castillo A, Castillo J, Cornejo I. The effects of respiratory muscle training on peak cough flow in patients with Parkinson's disease: a randomized controlled study. Clin Rehabil. 2018 Oct;32(10):1317-1327. doi: 10.1177/0269215518774832. Epub 2018 May 13. PMID 29756459
  • Reyes A, Castillo A, Castillo J, Cornejo I, Cruickshank T. The Effects of Respiratory Muscle Training on Phonatory Measures in Individuals with Parkinson's Disease. J Voice. 2020 Nov;34(6):894-902. doi: 10.1016/j.jvoice.2019.05.001. Epub 2019 May 31. PMID 31155431

Идентификаторы

NCT: NCT06473428 · 202306013RINA

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗