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Идёт набор NCT06893055

Strength-Endurance Circuit Training in Parkinson's Disease

Без фазы С лечением Parkinson Disease, Idiopathic

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: Strength-Endurance Training, Endurance Training.
Кому может быть актуально
Состояния в реестре: Parkinson Disease, Idiopathic. Базовые параметры: 18 лет — 75 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
Чехия
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

Strength-Endurance Circuit Training in Parkinson's Disease: Effects on Disease Severity, Physical Performance, Blood Biomarkers and Quality of Life.

Обзор

The goal of this clinical trial is to determine whether adding strength training to aerobic training has a comparable or greater effect on the clinical status of Parkinson's disease patients than a standalone aerobic training. \- Does combined strength-endurance circuit training provide added benefits to physical performance, disease severity, blood biomarkers, and quality of life in PD patients compared to standalone aerobic training? Participants will: * undergo outcome measurements before and after the 12-week intervention and a 3-month follow-up measurement, * visit the clinic twice a week for 1-hour training sessions. * selected patients will be given a smartwatch with a pedometer that will count their average number of steps before, during and after the training period

Вмешательства

  • Другое Strength-Endurance Training
    The intervention for the experimental Strength-Endurance group includes warm-up, three laps of strength and endurance exercises and cool-down. The training program lasts 3 months and includes two 1-hour training sessions per week, for a total of 24 sessions.
  • Другое Endurance Training
    The intervention for the control Endurance training group includes warm-up, three laps of endurance exercises and cool-down. The training program lasts 3 months and includes two 1-hour training sessions per week, for a total of 24 sessions.

Первичные конечные точки

  • Movement Disorders Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II. and III. [Срок оценки: From enrollment to the end of treatment at 12 weeks and 12 weeks after the end of treatment (Follow-up)]
Вторичные конечные точки (8)
  • One Repetition Maximum (1RM) [Срок оценки: From enrollment to the end of treatment at 12 weeks and 12 weeks after the end of treatment (Follow-up)]
  • Timed Up and Go Test (TUG) [Срок оценки: From enrollment to the end of treatment at 12 weeks and 12 weeks after the end of treatment (Follow-up)]
  • Blood irisin levels [Срок оценки: From enrollment to the end of treatment at 12 weeks and 12 weeks after the end of treatment (Follow-up)]
  • Cardiopulmonary Exercise Testing [Срок оценки: From enrollment to the end of treatment at 12 weeks and 12 weeks after the end of treatment (Follow-up)]
  • The Parkinson's Disease Questionnaire (PDQ-39) [Срок оценки: From enrollment to the end of treatment at 12 weeks and 12 weeks after the end of treatment (Follow-up)]
  • Blood brain-derived neurotrophic factor levels [Срок оценки: From enrollment to the end of treatment at 12 weeks and 12 weeks after the end of treatment (Follow-up)]
  • Blood cytokine levels [Срок оценки: From enrollment to the end of treatment at 12 weeks and 12 weeks after the end of treatment (Follow-up)]
  • Average number of steps [Срок оценки: Average number of steps in the period before training (6 months), during the training period (3 months), period after training (3 months).]

Критерии участия

Критерии включения

  • age ≥18 years
  • diagnosis of idiopathic Parkinson´s disease
  • Hoehn-Yahr Scale ≤ 2,5
  • stable dopaminergic medication

Критерии исключения

  • age ≥75 years
  • Hoehn-Yahr Scale ≥ 2,5
  • deep brain stimulation
  • presence of freezing
  • Camptocormia
  • inability to walk without support
  • inability to perform study procedures
  • limiting co-morbidities
  • attendance at training sessions below 70%

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
Простое слепое
Основная цель
Лечение

Центры проведения

Чехия · 1 центр
  • Department of Neurology and Centre of Clinical Neuroscience First Faculty of Medicine, Cha — Prague

Публикации

  • Corcos DM, Robichaud JA, David FJ, Leurgans SE, Vaillancourt DE, Poon C, Rafferty MR, Kohrt WM, Comella CL. A two-year randomized controlled trial of progressive resistance exercise for Parkinson's disease. Mov Disord. 2013 Aug;28(9):1230-40. doi: 10.1002/mds.25380. Epub 2013 Mar 27. PMID 23536417
  • Kam TI, Park H, Chou SC, Van Vranken JG, Mittenbuhler MJ, Kim H, A M, Choi YR, Biswas D, Wang J, Shin Y, Loder A, Karuppagounder SS, Wrann CD, Dawson VL, Spiegelman BM, Dawson TM. Amelioration of pathologic alpha-synuclein-induced Parkinson's disease by irisin. Proc Natl Acad Sci U S A. 2022 Sep 6;119(36):e2204835119. doi: 10.1073/pnas.2204835119. Epub 2022 Aug 31. PMID 36044549
  • Shi X, Gu Q, Fu C, Ma J, Li D, Zheng J, Chen S, She Z, Qi X, Li X, Wu S, Wang L. Relationship of irisin with disease severity and dopamine uptake in Parkinson's disease patients. Neuroimage Clin. 2024;41:103555. doi: 10.1016/j.nicl.2023.103555. Epub 2023 Dec 15. PMID 38134742
  • Gamborg M, Hvid LG, Dalgas U, Langeskov-Christensen M. Parkinson's disease and intensive exercise therapy - An updated systematic review and meta-analysis. Acta Neurol Scand. 2022 May;145(5):504-528. doi: 10.1111/ane.13579. Epub 2022 Jan 8. PMID 34997759

Идентификаторы

NCT: NCT06893055 · 56125

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗