Hospital-to-Home Rehabilitation Through Exercise and Cognitive Training

Официальное название

Comparación Entre Ingreso Hospitalario y Hospitalización Domiciliaria y Análisis de Una Intervención Multicomponente en Adultos Mayores: Ensayo Clínico Aleatorizado

Обзор

This research project is structured in two phases: an initial observational phase and a subsequent randomized controlled trial (RCT) phase. The goal of the observational phase is to compare hospital admission and Hospital at Home (HaH). The objective of the RCT is to assess the effectiveness of a multicomponent intervention following acute hospitalization in older adults. The main questions it aims to answer are: * What are the differences between hospital admission and HaH in sedentary and physical activity levels? * What are the effects of a multicomponent intervention following acute hospitalization in older adults? Researchers will compare a post-discharge multicomponent intervention to usual care to see the effects on physical and cognitive function. Participants will receive a home-based cognitive and physical exercise intervention or usual care.

Вмешательства

• Поведенческое Physical exercise and cognitive exercises
  The intervention will be based on the Vivifrail program, which is a multicomponent physical exercise program designed specifically for older adults.

Первичные конечные точки

• Physical function [Срок оценки: Within the first 24-48 hours of acute care admission (in hospital or home hospitalization), pre-intervention baseline, and immediately after the intervention.]
• Cognitive function [Срок оценки: Within the first 24-48 hours of acute care admission (in hospital or home hospitalization), pre-intervention baseline, and immediately after the intervention.]
• Physical activity [Срок оценки: During hospital stay or during home-base hospitalization .]
• Sedentarism [Срок оценки: During hospital stay or during home-based hospitalization.]

Вторичные конечные точки (12)

• Health-related quality of life (HRQOL) [Срок оценки: Pre-intervention baseline and immediately after the intervention.]
• Heart rate variability [Срок оценки: During hospital stay or during home-based hospitalization.]
• Handgrip strength [Срок оценки: Within the first 24-48 hours of acute care admission (in hospital or home hospitalization), pre-intervention baseline, and immediately after the intervention.]
• Sleep quantity [Срок оценки: During hospital stay or during home-based hospitalization.]
• Sleep quality [Срок оценки: During hospital stay or during home-based hospitalization.]
• Energy expenditure [Срок оценки: Within the first 24-48 hours of acute care admission (in hospital or home hospitalization), pre-intervention baseline, and immediately after the intervention.]
• Rate of hospital readmissions [Срок оценки: 3 months, 6 months, and 12 months post-discharge.]
• Rate of falls [Срок оценки: 3 months, 6 months, and 12 months post-discharge.]
• Incidence of mortality [Срок оценки: 3 months, 6 months, and 12 months post-discharge.]
• Rate of emergency visits [Срок оценки: 3 moths, 6 months, and 12 months post-discharge.]
• Prescribed pharmacologic treatment [Срок оценки: Within the first 24-48 hours of acute care admission (in hospital or home hospitalization), pre-intervention baseline, and immediately after the intervention.]
• Cost-effectiveness [Срок оценки: At pre-intervention baseline, at 3 months post-discharge, at 6 months post-discharge, and at 12 months post-discharge.]

Критерии участия

Критерии включения

• Older adults admitted to the hospital or Hospital at Home (HaH) due to an acute illness.
• Residents of Navarre.
• Willingness to participate on a voluntary basis.
• Ability to ambulate with or without assistance.
• Ability to communicate and collaborate with the research staff.

Критерии исключения

• Acute illness that does not allow the assessment and practice of physical exercise during the study.
• Medical contraindication for the practice of physical exercise.
• Severe dementia.
• Refusal to sign the informed consent form by the patient, accompanying person, or legal guardian.

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

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07183241 · PI_2025/34

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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