Multicomponent Exercise and Virtual Reality for Older Adults
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: Multicomponent Exercise plus Non-Immersive Virtual Reality, Non-Immersive Virtual Reality.
- Кому может быть актуально
- Состояния в реестре: Frailty, Aging, Functional Impairment. Базовые параметры: от 65 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
- Испания
- 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
Effects of a Combined Multicomponent Exercise and Non-Immersive Virtual Reality Program on Functionality, Balance, Cognition, and Occupational Participation in Older Adults: A Mixed-Methods Pilot Study With a Control Group
Обзор
Population aging is associated with an increased risk of frailty, falls, and loss of autonomy. This pilot study aims to evaluate the effects of a program that combines multicomponent exercise and non-immersive virtual reality (MCE+VR-NI), compared with virtual reality alone (VR-NI) and usual treatment. The primary objective is to determine the program's impact on physical function, balance, cognition, and occupational participation in community-dwelling adults aged over 65 years.
Подробное описание
This is a mixed-methods pilot study consisting of a two-arm randomized controlled trial and a non-randomized parallel cohort for the control group. Participants will be allocated in a 1:1:1 ratio to the intervention or control groups. The intervention period will last 8 weeks. Quantitative outcomes (SPPB, FRAIL Scale, TUG, MoCA, COPM, WHODAS 2.0) will be assessed at baseline and post-intervention. In addition, qualitative interviews will be conducted to explore participants' subjective experiences and motivation.
Вмешательства
- Поведенческое Multicomponent Exercise plus Non-Immersive Virtual Reality
Participants will undergo an 8-week multicomponent exercise program combined with non-immersive virtual reality (VR). Sessions will be conducted twice weekly (60 minutes each) and will include strength, balance, coordination, and functional mobility training, along with VR-based motor and cognitive stimulation using a non-immersive system. The intervention will be delivered in a supervised group setting. - Поведенческое Non-Immersive Virtual Reality
Participants will receive non-immersive virtual reality training for 8 weeks, with two supervised sessions per week (60 minutes each), focused on motor and cognitive stimulation.
Первичные конечные точки
- Change in physical function (SPPB score) [Срок оценки: Baseline and 8 weeks]
Вторичные конечные точки (6)
- Change in mobility (Timed Up and Go test) [Срок оценки: Baseline and 8 weeks]
- Change in handgrip strength [Срок оценки: Baseline and 8 weeks]
- Change in cognitive function (MoCA score) [Срок оценки: Baseline and 8 weeks]
- Change in frailty status (FRAIL Scale) [Срок оценки: Baseline and 8 weeks]
- Change in occupational performance and satisfaction (COPM) [Срок оценки: Baseline and 8 weeks]
- Change in disability and participation (WHODAS 2.0) [Срок оценки: Baseline and 8 weeks]
Критерии участия
Критерии включения
- Participants must be aged 65 years or older.
- A score of ≥23 points on the Montreal Cognitive Assessment (MoCA) score
- Functional independence or minimal dependence in activities of daily living (A score of >90 on the Barthel Index).
- Participants must be able to understand instructions and provide written informed consent.
Критерии исключения
- Conditions that prevent walking or safe participation in a group intervention.
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
- Простое слепое
- Основная цель
- Лечение
Центры проведения
Испания · 1 центр
- INNOVEAS Innovation Center, Spanish Red Cross (Valladolid), Spain — Valladolid
Публикации
- Sherrington C, Fairhall NJ, Wallbank GK, Tiedemann A, Michaleff ZA, Howard K, Clemson L, Hopewell S, Lamb SE. Exercise for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2019 Jan 31;1(1):CD012424. doi: 10.1002/14651858.CD012424.pub2. PMID 30703272
- Izquierdo M, Merchant RA, Morley JE, Anker SD, Aprahamian I, Arai H, Aubertin-Leheudre M, Bernabei R, Cadore EL, Cesari M, Chen LK, de Souto Barreto P, Duque G, Ferrucci L, Fielding RA, Garcia-Hermoso A, Gutierrez-Robledo LM, Harridge SDR, Kirk B, Kritchevsky S, Landi F, Lazarus N, Martin FC, Marzetti E, Pahor M, Ramirez-Velez R, Rodriguez-Manas L, Rolland Y, Ruiz JG, Theou O, Villareal DT, Waters PMID 34409961
- Gine-Garriga M, Roque-Figuls M, Coll-Planas L, Sitja-Rabert M, Salva A. Physical exercise interventions for improving performance-based measures of physical function in community-dwelling, frail older adults: a systematic review and meta-analysis. Arch Phys Med Rehabil. 2014 Apr;95(4):753-769.e3. doi: 10.1016/j.apmr.2013.11.007. Epub 2013 Nov 27. PMID 24291597
Идентификаторы
NCT: NCT07529743 · Line1-MOVE ON. 090120260362026 · Line 1- MOVE ON