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Идёт набор NCT07492745

Effect of Using a Reminder to Encourage Patients to be Active During Their Hospital Stay.

Без фазы С лечением Inpatients Frail

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: Vibrating reminder, Control group.
Кому может быть актуально
Состояния в реестре: Inpatients, Frail. Базовые параметры: от 50 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
Бельгия, Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Effect of Using a Reminder to Encourage Patients to be Active During Their Hospital Stay : a Multicenter Randomised Controlled Double Blind Study.

Обзор

Around 30% of patients aged 65 and over experience functional decline due to hospitalization. Physical inactivity, often without medical justification, is common during hospital stays.This immobility leads to loss of autonomy, muscle strength, and increases post-discharge risks. Slow walking for 25-40 minutes daily significantly improves functional capacity. However, it could be difficult to reach this time of walking due to a lack of physiotherapist in hospital. A vibrating watch may encourage patients to walk or perform strengthening exercises. This simple intervention aims to improve function without requiring additional staff or resources

Подробное описание

30% of patients aged 65 or older will experience a decline in functional capacity as a result of hospitalization.

Illness and hospitalization increase sedentary behavior in patients. It is common for patients to spend long periods of time resting in bed, regardless of their primary reason for admission. During hospitalization, nearly 60% of episodes of bed rest have no documented medical indications. Low physical activity during hospitalization can lead to impaired independence, loss of muscle strength, and decreased functional capacity. These losses in frail individuals are associated with increased disability and lead to a critical 30-day period after hospital discharge that exacerbates deconditioning. This period of increasing functional vulnerability can lead to readmission to hospital, disability, institutionalization, morbidity, and early mortality.

The results of a meta-analysis show that walking slowly for about 25-40 minutes per day is sufficient to improve patients' functional capacity during hospitalization. The organization of care to promote patient mobility must be reviewed to make patients more involved in their care and more independent.

It has been demonstrated for some time that the use of a reminder system (e.g., alarm) is a factor that promotes increased patient adherence to their treatments. The advantage of a vibrating reminder is that it is simple to use, very inexpensive, easy to implement in all hospital wards, and does not require additional human resources.

The main hypothesis of this study is that the use of a vibrating watch set to 6 reminders per day to prompt patients to perform muscle strengthening exercises or walk a distance determined by the rehabilitation professional will increase patients' functional capacity.

Вмешательства

  • Устройство Vibrating reminder
    The exercises will be prescribed according to the patient's physical abilities and environmental constraints. A vibrating reminder will be given to the patient, set to go off six times a day.
  • Устройство Control group
    The exercises will be prescribed according to the patient's physical abilities and environmental constraints. A vibrating reminder will be given to the patient, set to go off once time a day.

Первичные конечные точки

  • SPPB [Срок оценки: Within 24 hours of admission and within 48 hours prior to discharge from hospital.]
Вторичные конечные точки (7)
  • Volume and intensity of physical activity [Срок оценки: Within 24 hours of admission and within 48 hours prior to discharge from hospital.]
  • functional independancy [Срок оценки: Within 24 hours of admission and within 48 hours prior to discharge from hospital.]
  • Patient compliance to the prescribed exercises [Срок оценки: Within 24 hours of baseline and within 48 hours prior to discharge from hospital]
  • falls [Срок оценки: Within 24 hours of baseline and within 48 hours prior to discharge from hospital ; and at 3 months after discharge.]
  • Volume and type of rehabilitation in-hospital [Срок оценки: Within 24 hours of baseline and within 48 hours prior to discharge from hospital]
  • The volume and location of rehabilitation [Срок оценки: at 3 months after discharge]
  • Health-related Quality of life [Срок оценки: 24 hours after admission, 48 hours before discharge, and 3 months after hospitalization]

Критерии участия

Критерии включения

  • Patients aged 50 or over with a score of 4 or above on the Clinical Frailty Scale (vulnerable but not dependent patients, symptoms limiting activities, patients who are slower/more fatigued).
  • Must be able to get up from a chair without assistance.
  • Patients must be able to communicate with staff, understand instructions, give consent, and cooperate with staff.

Критерии исключения

  • Patients with an estimated hospital stay of less than 5 days.
  • Contraindications to physical activity determined by the medical team (e.g., cardiovascular instability, orthopedic contraindications, etc.).
  • Terminal illness.
  • Patients scheduled for surgery.
  • Pregnant women.
  • People who do not understand French.
  • People protected under the law.

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
Тройное слепое
Основная цель
Профилактика

Центры проведения

Франция · 3 центра
  • Groupe Hospitalier du Havre — Le Havre
  • Centre hospitalier de Chartres — Le Coudray
  • centre hospitalier de Valence — Valence
Бельгия · 1 центр
  • Hôpital Erasme Route de Lennick 808 — Brussels

Идентификаторы

NCT: NCT07492745 · 25.01855.000458 · PHRIP-23-0006

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗