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Идёт набор NCT06270641

Increasing Physical Activity for Adults With Multiple Sclerosis (MS)

Без фазы С лечением Multiple Sclerosis (MS) Fatigue Physical Inactivity

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: ExerciseRx intervention.
Кому может быть актуально
Состояния в реестре: Multiple Sclerosis (MS), Fatigue, Physical Inactivity. 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
США
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

Increasing Physical Activity Via Provider Prescription and Engagement: Efficacy of ExerciseRx for Adults With Multiple Sclerosis (MS)

Обзор

This study aims to advance the scientific understanding and potential future implementation of physical activity promotion by testing the efficacy of a phone-based app for increasing activity in insufficiently active patients with multiple sclerosis (MS).

Подробное описание

This study aims to test the efficacy of ExerciseRx, a free software platform designed to increase physical activity in people with multiple sclerosis (PwMS). Exercise is crucial for managing MS symptoms and overall health, but approximately 80% of PwMS do not get enough physical activity due to barriers like physical limitations, common MS symptoms, and lack of community exercise facilities. ExerciseRx translates clinically relevant activity data collected by personal smart devices into actionable metrics on a dashboard within the Epic electronic health record, allowing healthcare providers to prescribe and monitor tailored physical activity solutions for their patients. This study will test the effects of ExerciseRx in a sample of inactive PwMS.

Вмешательства

  • Другое ExerciseRx intervention
    ExerciseRx is a cloud-based, HIPPA-compliant free software platform created for healthcare providers to prescribe and monitor physical activity as part of routine care. ExerciseRx translates clinically relevant activity data collected by the patient's existing personal smart devices (Android or iOS phone) into actionable metrics on a dashboard within the Epic electronic health record. Providers then use the platform to prescribe physical activity tailored to patients' ability levels and preferen

Первичные конечные точки

  • Physical activity: daily average step count [Срок оценки: Baseline and week 13]
Вторичные конечные точки (10)
  • Activity volume [Срок оценки: Baseline, weeks 13 and 26]
  • Minutes/week of moderate intensity aerobic activity [Срок оценки: Baseline, weeks 13 and 26]
  • Fatigue - PROMIS Fatigue-MS Short Form 8a [Срок оценки: Baseline, weeks 13 and 26]
  • Pain intensity - PROMIS Pain Intensity Short Form 3a [Срок оценки: Baseline, weeks 13 and 26]
  • Depressive symptom severity - PROMIS Depression Short Form 8a [Срок оценки: Baseline, weeks 13 and 26]
  • Sleep disturbance - PROMIS Sleep Disturbance Short Form 6a [Срок оценки: Baseline, weeks 13 and 26]
  • Physical functioning - PROMIS Physical Function 10a [Срок оценки: Baseline, weeks 13 and 26]
  • Pain interference - PROMIS Pain Interference Scale Short Form 6a [Срок оценки: Baseline, weeks 13 and 26]
  • Social participation - PROMIS Satisfaction with Social Roles and Activities Short Form 8a [Срок оценки: Baseline, weeks 13 and 26]
  • Social participation - PROMIS Ability to Participate in Social Roles and Activities Short Form 8a [Срок оценки: Baseline, weeks 13 and 26]

Критерии участия

Критерии включения

  • Provider-confirmed diagnosis of MS using revised 2017 McDonald criteria
  • > 18+ years of age
  • Patient determined disease steps (PDDS) score < 3, indicating the potential for some gait disability although typically ambulates without an assistive device
  • Insufficiently active, defined as < 150 minutes of physical activity per week, assessed using the PAVS in the EHR in clinics as part of the routine patient intake process
  • Use of an iPhone with software version iOS13+ or an Android phone 4.1+
  • Agree to install and use the ExerciseRx app for the entire study period and keep their phone on them during the daytime (e.g., pocket, bags, hands)

Критерии исключения

  • Recent (past 4 weeks) or planned surgery during the study period which may impact engaging in step counts
  • MS relapse within the last 30 days
  • Plans to travel internationally during the study period, which could interfere with server uploads of mobile phone data
  • Those at a higher risk of falling or injury from falls or unable to safely exercise due to other medical conditions (e.g. heart conditions, diabetes or conditions made worse by walking or physical activity)

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • UW Medicine — Seattle

Публикации

  • Ehde DM, Simmons SB, Alschuler KN, Herring TE, Humbert AT, Robles SR, Ioseliani O, Landis K, Kavanagh LB, Lin CY. Increasing Physical Activity via Provider Support and Engagement Using a Digital Health Platform in Adults With Multiple Sclerosis: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Nov 21;14:e72213. doi: 10.2196/72213. PMID 41268963

Идентификаторы

NCT: NCT06270641 · STUDY00018628

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗