STEPWISE Parkinson: A Smartphone Based Exercise Solution for Patients With Parkinson's Disease
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: Step count increase with the use of a motivational smartphone application.
- Кому может быть актуально
- Состояния в реестре: Movement Disorders, Parkinson Disease. 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
- Нидерланды
- 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
STEPWISE Parkinson: A Smartphone Based, Titrated Exercise Solution for Patients With Parkinson's Disease in Daily Life
Обзор
The aim of this study is to investigate whether a smartphone app can increase physical activity in patients with Parkinson's Disease in daily life for a long period of time (12 months).
Подробное описание
Rationale: Exercise affords health benefits for people with Parkinson's disease (PD), but implementing exercise in daily life remains challenging. Moreover, many training programs are not very scalable. The investigators take an important step forward by developing and studying an innovative and fully decentralized smartphone-based program to increase long-term physical activity in people with PD in daily life.
Objective: The aim of this study is to investigate whether a smartphone app can increase physical activity in PD patients for a long period of time (12 months). The secondary aim is to test the potential group effect on physical fitness, motor- and non-motor symptoms. Thirdly, we aim to investigate whether there is a dose-response relationship between amount of physical activity and physical fitness, motor- and non-motor functioning.
Study design: Double-blind randomized controlled trial.
Study population: A total of 452 Dutch patients with PD who have no other medical conditions that markedly hamper mobility other than PD, no cognitive impairments that make it difficult to use a game on the smartphone and possess a suitable smartphone, will be recruited.
Intervention: Participants will be randomized to a group that will be motivated to increase their physical activity level to a small, medium, large or very large degree with respect to their own baseline level.
Вмешательства
- Поведенческое Step count increase with the use of a motivational smartphone application
All participants will be given access to an application installed on the participants' own smartphone: the STEPWISE app. The STEPWISE app will encourage participants to increase their long-term physical activity (1 year). Different treatment arms will receive different physical activity goals. Participants will get feedback and support via the smartphone app, that stimulates them to reach their individual physical activity goal (i.e. target percentage increase in stepcount).
Первичные конечные точки
- Mean change in step count per day [Срок оценки: Week -4 until 0 and week 49 until 52]
Вторичные конечные точки (12)
- Change in physical fitness (6MWT) [Срок оценки: Week 0 (baseline) and week 53 (follow-up)]
- Change in motor- and non-motor aspects of daily living [Срок оценки: Week 0 (baseline) and week 53 (follow-up)]
- Change in physical fitness (VO2max) [Срок оценки: Week 0 (baseline) and week 53 (follow-up)]
- Change in Parkinson's Disease symptoms (MDS-UPDRS) [Срок оценки: Week 0 (baseline) and week 53 (follow-up)]
- Change in ambulatory capacity (MDS-UPDRS) [Срок оценки: Week 0 (baseline) and week 53 (follow-up)]
- Change in mobility (TUG) [Срок оценки: Week 0 (baseline) and week 53 (follow-up)]
- Change in balance (Mini-BestTest) [Срок оценки: Week 0 (baseline) and week 53 (follow-up)]
- Change in gait speed (10MWT) [Срок оценки: Week 0 (baseline) and week 53 (follow-up)]
- Change in fear of falling (FES-I) [Срок оценки: Week 0 (baseline) and week 53 (follow-up)]
- Number of falls and near-falls (monthly fall diary) [Срок оценки: Every four weeks after start of the intervention (at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 weeks).]
- Change in handgrip strength [Срок оценки: Week 0 (baseline) and week 53 (follow-up)]
- Change in self-reported physical activity level (LAPAQ) [Срок оценки: Week -4 (screening), week 0 (baseline) and week 53 (follow-up)]
Критерии участия
Критерии включения
- idiopathic PD
- Hoehn and Yahr 1-3
- able to understand the Dutch language
- able to walk independently
- equal to or less than 120 minutes of sports/outdoor activities per day (question 5-28 LASA Physical Activity Questionnaire (LAPAQ))
- less than 7,000 steps/day during 1-month baseline (week -4 until 0)
Критерии исключения
- weekly falls in the previous 3 months
- medical conditions that hamper mobility other than PD
- living in a nursing home
- cognitive impairments that hamper use of the motivational app (subjective evaluation by the assessor)
- not in the possession of a suitable smartphone (Iphone 5S or newer with iOS 10 or higher or Android 4.1 or newer)
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
- Четверное слепое
- Основная цель
- Лечение
Центры проведения
Нидерланды · 1 центр
- Radboud university medical center — Nijmegen
Публикации
- Schootemeijer S, de Vries NM, Macklin EA, Roes KCB, Joosten H, Omberg L, Ascherio A, Schwarzschild MA, Bloem BR. The STEPWISE study: study protocol for a smartphone-based exercise solution for people with Parkinson's Disease (randomized controlled trial). BMC Neurol. 2023 Sep 12;23(1):323. doi: 10.1186/s12883-023-03355-8. PMID 37700241
Идентификаторы
NCT: NCT04848077 · NL75501.091.20