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Набор скоро начнётся NCT07504120

The Effect of Remotely Delivered Pilates on Physical , and Psychological Outcomes in Individuals With Multiple Sclerosis

Без фазы С лечением Multiple Sclerosis Pilates Exercise Walking Balance

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: Pilates.
Кому может быть актуально
Состояния в реестре: Multiple Sclerosis, Pilates Exercise, Walking, Balance. Базовые параметры: от 18 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

Does Remotely Delivered Pilates Influence Physical and Psychological Outcomes in Individuals With Multiple Sclerosis?

Обзор

Objectives Objective 1: To determine the effects of a 16-week remotely delivered Pilates intervention on walking endurance, walking speed, balance, fatigue, and pain compared to a waitlist control group in individuals with MS. Objective 2: To examine the impact of a 16-week remotely delivered Pilates intervention on depression \& anxiety, cognitive function, and QOL compared to a waitlist control group in individuals with MS. Aim Aim 1: To assess whether the 16-week remotely delivered Pilates intervention significantly improves walking endurance, walking speed, balance, fatigue, and pain compared to a waitlist control group in individuals with MS Aim 2: To investigate whether the 16-week remotely delivered Pilates intervention significantly improves depression \& anxiety, cognitive function, and QOL compared to a waitlist control group in individuals with MS. Hypothesis Hypothesis 1: The 16-week remotely delivered Pilates intervention will significantly improve walking endurance, walking speed, balance, fatigue, and pain compared to a waitlist control group in individuals with MS. Hypothesis 2: Participants receiving the 16-week remotely delivered Pilates intervention will demonstrate significantly greater improvements in depression \& anxiety, cognitive function, and QOL compared to a waitlist control group in individuals with MS.

Подробное описание

The current study will determine the feasibility and efficacy of a 16-week remotely delivered Pilates intervention for improving physical and psychological outcomes, and QOL, compared with a control condition, in individuals with MS. This represents a significant step forward in examining Pilates as an accessible, complementary therapy in MS.

Вмешательства

  • Поведенческое Pilates
    REMOTLY PILATES EXERCISE

Первичные конечные точки

  • Change from baseline in walking endurance (Six-Minute Walk Test distance) [Срок оценки: Baseline and 16 weeks (end of treatment)]
  • Change from baseline in walking speed (Timed 25-Foot Walk) [Срок оценки: Baseline and 16 weeks (end of treatment)]
  • Change from baseline in balance (Berg Balance Scale) [Срок оценки: Baseline and 16 weeks (end of treatment)]
  • Change from baseline in fatigue (Fatigue Severity Scale) [Срок оценки: Baseline and 16 weeks (end of treatment)]
  • Change from baseline in pain (Short-form McGill Pain Questionnaire) [Срок оценки: Baseline and 16 weeks (end of treatment)]
Вторичные конечные точки (6)
  • Change from baseline in cognitive processing speed (Symbol Digit Modalities Test) [Срок оценки: Baseline and 16 weeks (end of treatment)]
  • Change from baseline in verbal learning and memory (California Verbal Learning Test-II) [Срок оценки: Baseline and 16 weeks (end of treatment)]
  • Change from baseline in visuospatial learning and memory (Brief Visuospatial Memory Test-Revised) [Срок оценки: Baseline and 16 weeks (end of treatment)]
  • Change from baseline in depression symptoms [Срок оценки: Baseline and 16 weeks (end of treatment)]
  • Change from baseline in anxiety symptoms [Срок оценки: Baseline and 16 weeks (end of treatment)]
  • Change from baseline in health-related quality of life [Срок оценки: Baseline and 16 weeks (end of treatment)]

Критерии участия

Критерии включения

  • Age 18 years or older
  • Self-reported diagnosis of multiple sclerosis by a neurologist
  • Relapse-free for the past 30 days before screening
  • Able to speak and read English as the primary language
  • Access to the internet and e-mail,
  • Ability to use Zoom, and willingness to complete testing sessions and questionnaires
  • Ambulatory without an assistive device (for example, cane)
  • Low to moderate disability, defined as a score of 0-4 on the Patient-Determined Disease Steps (PDDS)
  • Insufficiently active, defined as a score < 14 on the Godin Leisure-Time Exercise Questionnaire-Health Contribution Score (GLTEQ-HCS)
  • Adequate visual ability and literacy to read materials printed in 14-point font
  • Currently treated with a disease-modifying therapy

Критерии исключения

  • Pregnant
  • Elevated risk for strenuous or maximal exercise, defined as more than one "Yes" response on the Physical Activity Readiness Questionnaire (PAR-Q) during screening

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
Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07504120 · STUDY2025-0648-MOD001 · MB-2110-38597

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗