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Hospital-to-Home Rehabilitation Through Exercise and Cognitive Training

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07183241
Acronym
H-REACT
Enrollment
200
Registered
2025-09-19
Start date
2025-10-31
Completion date
2027-06-30
Last updated
2025-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Hospitalization

Keywords

acute hospitalization, older adults, exercise, hospital at home, cognitive

Brief summary

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

BEHAVIORALPhysical 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.

Sponsors

Universidad Pública de Navarra
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

This research project is structured in two phases: an initial observational phase comparing hospital admission and hospital at home, and a subsequent randomized controlled trial phase assessing the efficacy of a multicomponent post-hospitalization intervention.

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Physical functionWithin 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.
Cognitive functionWithin 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.
Physical activityDuring hospital stay or during home-base hospitalization .Physical activity will be assessed with a Firstbeat device (format: hh:mm:ss).
SedentarismDuring hospital stay or during home-based hospitalization.Sedentarism will be assessed with a Firstbeat device (format: hh:mm:ss).

Secondary

MeasureTime frameDescription
Sleep qualityDuring hospital stay or during home-based hospitalization.The heart rate variability parameter RMSSD (measured in ms) will be assessed during sleep.
Energy expenditureWithin 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.
Rate of hospital readmissions3 months, 6 months, and 12 months post-discharge.Number of readmissions of each patient will be registered using the information from the medical records.
Rate of falls3 months, 6 months, and 12 months post-discharge.The number of falls for each patient will be recorded through follow-up phone calls.
Health-related quality of life (HRQOL)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.
Rate of emergency visits3 moths, 6 months, and 12 months post-discharge.Number of emergency visits will be registered using the information from the medical records.
Prescribed pharmacologic treatmentWithin 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.
Cost-effectivenessAt 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.
Incidence of mortality3 months, 6 months, and 12 months post-discharge.Number of deaths will be registered using the information from the medical records.
Heart rate variabilityDuring hospital stay or during home-based hospitalization.Heart rate variability will be assessed usign a Firstbeat device.
Handgrip strengthWithin 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.
Sleep quantityDuring hospital stay or during home-based hospitalization.Sleep duration will be recorded (format: hh:mm:ss).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026