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Not yet recruiting NCT07183241

Hospital-to-Home Rehabilitation Through Exercise and Cognitive Training

No phase Interventional Acute Hospitalization

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Physical exercise and cognitive exercises.
Who it may be relevant to
Registry conditions: Acute Hospitalization. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Behavioral 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.

Primary outcome measures

  • Physical function [Time frame: 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 [Time frame: 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 [Time frame: During hospital stay or during home-base hospitalization .]
  • Sedentarism [Time frame: During hospital stay or during home-based hospitalization.]
Secondary outcome measures (12)
  • Health-related quality of life (HRQOL) [Time frame: Pre-intervention baseline and immediately after the intervention.]
  • Heart rate variability [Time frame: During hospital stay or during home-based hospitalization.]
  • Handgrip strength [Time frame: 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 [Time frame: During hospital stay or during home-based hospitalization.]
  • Sleep quality [Time frame: During hospital stay or during home-based hospitalization.]
  • Energy expenditure [Time frame: 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 [Time frame: 3 months, 6 months, and 12 months post-discharge.]
  • Rate of falls [Time frame: 3 months, 6 months, and 12 months post-discharge.]
  • Incidence of mortality [Time frame: 3 months, 6 months, and 12 months post-discharge.]
  • Rate of emergency visits [Time frame: 3 moths, 6 months, and 12 months post-discharge.]
  • Prescribed pharmacologic treatment [Time frame: 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 [Time frame: At pre-intervention baseline, at 3 months post-discharge, at 6 months post-discharge, and at 12 months post-discharge.]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07183241 · PI_2025/34

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗