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Набор скоро начнётся NCT06983574

Effectiveness of an mHealth Application to Promote Home-Based Exercise in Adults Aged 65 and Older

Без фазы С лечением Healthy

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: MIA.
Кому может быть актуально
Состояния в реестре: Healthy. 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
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

Evaluating the Effectiveness of an mHealth Application to Promote Home-Based Exercise in Adults Aged 65 and Older: A Randomized Controlled Trial

Обзор

The goal of this clinical trial is to learn if drug ABC works to evaluate the effectiveness of an mHealth application to promote home-based exercise in adults aged 65 and older. The objectives are: Primary objective: • To evaluate the effect of the mHealth application on increasing moderate-to-vigorous physical activity levels. Secondary objectives: * To assess the impact of the mHealth application on physical fitness measures (e.g., functional capacity, strength, balance, fall risk, flexibility) * To assess the impact of the mHealth application on physical activity (e.g., daily steps, self-reported physical activity) * To examine the impact of the mHealth application on wellbeing * To explore the impact of the mHealth application on cognitive functioning * To measure user adherence and engagement with the mHealth application * To evaluate participant satisfaction with the mHealth application Researchers will compare a group using an mHealth application to a group not using the application to determine whether it effectively increases physical activity. Participants will: * Use the mHealth application or not for 8 weeks * Visit the labo 3 times in total for assessements * Use a wearable during the study period

Вмешательства

  • Другое MIA
    Through a collaborative co-creation process, MIA, a mHealth app was developed and refined over multiple iterations with the goal of promoting physical activity and fostering a lifestyle centred around an active and healthy approach. Content and design were derived from both the co-creative workshops and based on the theoretical framework of the intervention functions of the BCW. The final mHealth app is composed by five major features: * Tailor-made tips * Literacy aiming to improve awareness a

Первичные конечные точки

  • MVPA [Срок оценки: From enrollment to 3 months post-intervention]
Вторичные конечные точки (12)
  • Gait speed [Срок оценки: From enrollment to the end of intervention at 8 weeks]
  • Quadriceps force [Срок оценки: From enrollment to the end of intervention at 8 weeks]
  • Handgrip strength [Срок оценки: From enrollment to the end of intervention at 8 weeks]
  • Balance [Срок оценки: From enrollment to the end of intervention at 8 weeks]
  • Fall risk [Срок оценки: From enrollment to the end of intervention at 8 weeks]
  • Flexibility [Срок оценки: From enrollment to the end of intervention at 8 weeks]
  • Muscle power [Срок оценки: From enrollment to the end of intervention at 8 weeks]
  • Daily steps [Срок оценки: From enrollment to 3 months post-intervention]
  • IPAQ-SF [Срок оценки: From enrollment to the end of intervention at 8 weeks]
  • ESES [Срок оценки: From enrollment to the end of intervention at 8 weeks]
  • BREQ [Срок оценки: From enrollment to the end of intervention at 8 weeks]
  • PACES [Срок оценки: From enrollment to the end of intervention at 8 weeks]

Критерии участия

Критерии включения

  • 65 years or older
  • Medically stable Any existing chronic illnesses (e.g., hypertension, diabetes, or arthritis) are being effectively managed with medications or lifestyle interventions.

The participant is not experiencing any recent or ongoing acute medical conditions, such as infections, recent surgeries, or injuries, that could interfere with participation in the study.

  • No significant cognitive, mental or physical impairment that would prevent safe use of the mHealth application or performance of the exercises.
  • Understanding and speaking Dutch
  • Access to a smartphone and computer.

Критерии исключения

  • The presence of an active lifestyle.
  • Enrolment in other exercise programs or clinical trials that might interfere with study participation or outcomes.
  • Any condition or circumstance deemed by a healthcare professional to pose a risk to the participant's safety or the validity of the study.

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
Открытое
Основная цель
Фундаментальное исследование

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

  • Quadflieg K, Robijns J, Daniels K. Evaluating the effectiveness of an mHealth application to promote home-based exercise in adults aged 65 years and older: protocol for a randomised controlled trial. BMJ Open. 2025 Nov 4;15(11):e106629. doi: 10.1136/bmjopen-2025-106629. PMID 41193218

Идентификаторы

NCT: NCT06983574 · HOME-FIT

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗