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NCT Number: NCT07183241

Hospital-to-Home Rehabilitation Through Exercise and Cognitive Training

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.

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Key information

Conditions

Acute Hospitalization Behavior Motor Activity

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Physical exercise and cognitive exercises

Behavioral

The intervention will be based on the Vivifrail program, which is a multicomponent physical exercise program designed specifically for older adults.

Primary outcomes

  1. 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.

    Short Physical Performance Battery (SPPB): scores range from 0 to 12, with higher scores indicating better physicalfunction.

  2. 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.

    Mini-Mental State Examination (MMSE): scores range from 0 to 30, with higher scores indicating better cognitive function.

  3. Physical activity

    Time frame: During hospital stay or during home-base hospitalization .

    Physical activity will be assessed with a Firstbeat device (format: hh:mm:ss).

  4. Sedentarism

    Time frame: During hospital stay or during home-based hospitalization.

    Sedentarism will be assessed with a Firstbeat device (format: hh:mm:ss).

Secondary outcomes

  1. Health-related quality of life (HRQOL)

    Time frame: Pre-intervention baseline and immediately after the intervention.

    EQ-5D-5L provides a health profile that is converted to a utility index, in which 0 is equivalent to death and 1 indicates perfect health. Additionally, the EQ-VAS ranges from 0 to 100, with higher scores indicating better health.

  2. Heart rate variability

    Time frame: During hospital stay or during home-based hospitalization.

    Heart rate variability will be assessed usign a Firstbeat device.

  3. 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.

    Handgrip strength will be measured using a handgrip dynamometer.

  4. Sleep quantity

    Time frame: During hospital stay or during home-based hospitalization.

    Sleep duration will be recorded (format: hh:mm:ss).

  5. Sleep quality

    Time frame: During hospital stay or during home-based hospitalization.

    The heart rate variability parameter RMSSD (measured in ms) will be assessed during sleep.

  6. 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.

    Energy expenditure (kcal) will be assessed in with a Firstbeat device.

  7. Rate of hospital readmissions

    Time frame: 3 months, 6 months, and 12 months post-discharge.

    Number of readmissions of each patient will be registered using the information from the medical records.

  8. Rate of falls

    Time frame: 3 months, 6 months, and 12 months post-discharge.

    The number of falls for each patient will be recorded through follow-up phone calls.

  9. Incidence of mortality

    Time frame: 3 months, 6 months, and 12 months post-discharge.

    Number of deaths will be registered using the information from the medical records.

  10. Rate of emergency visits

    Time frame: 3 moths, 6 months, and 12 months post-discharge.

    Number of emergency visits will be registered using the information from the medical records.

  11. 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.

    All medications prescribed to each patient will be recorded using the information from the medical records.

  12. Cost-effectiveness

    Time frame: At pre-intervention baseline, at 3 months post-discharge, at 6 months post-discharge, and at 12 months post-discharge.

    Cost-effectiveness will be assessed by calculating the cost per Quality-Adjusted Life Year (QALY) gained.

Sponsors and collaborators

Lead sponsor

Universidad Pública de Navarra

Other

Registry information

Official study title

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

Acronym: H-REACT

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Sep 19, 2025
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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