Acute HospitalizationH-REACTNCT07183241
Hospital-to-Home Rehabilitation Through Exercise and Cognitive Training
A study testing Physical exercise and cognitive exercises in people with Acute Hospitalization, run by Universidad Pública de Navarra at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Acute Hospitalization
- What is being tested?
- Physical exercise and cognitive exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSpain
- Study dates
- 22 Oct 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Navarrabiomed, Hospital Universitario de Navarra (HUN) - Universidad Pública de Navarra (UPNA), Pamplona, Spain
Pamplona, Navarre, 31015
Mikel Izquierdo, Professor, +34 948131495, mikel.izquierdo@gmail.com
About this study
Official title: Comparación Entre Ingreso Hospitalario y Hospitalización Domiciliaria y Análisis de Una Intervención Multicomponente en Adultos Mayores: Ensayo Clínico Aleatorizado
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?
Read more
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.
- Conditions
- Acute Hospitalization
- Being tested
- Physical exercise and cognitive exercises
- Keywords
- acute hospitalization, older adults, exercise, hospital at home, cognitive
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical exercise and cognitive exercisesBehavioural
The intervention will be based on the Vivifrail program, which is a multicomponent physical exercise program designed specifically for older adults.
| Study group | Role | What they receive |
|---|---|---|
| Multicomponent intervention | Experimental | Physical exercise and cognitive exercises Receives: Behavioral: Physical exercise and cognitive exercises |
| Usual care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical function
Short Physical Performance Battery (SPPB): scores range from 0 to 12, with higher scores indicating better physicalfunction.
Measured: 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
Mini-Mental State Examination (MMSE): scores range from 0 to 30, with higher scores indicating better cognitive function.
Measured: 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
Physical activity will be assessed with a Firstbeat device (format: hh:mm:ss).
Measured: During hospital stay or during home-base hospitalization .
Sedentarism
Sedentarism will be assessed with a Firstbeat device (format: hh:mm:ss).
Measured: During hospital stay or during home-based hospitalization.
Secondary outcomes (12)
Health-related quality of life (HRQOL)
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.
Measured: Pre-intervention baseline and immediately after the intervention.
Heart rate variability
Heart rate variability will be assessed usign a Firstbeat device.
Measured: During hospital stay or during home-based hospitalization.
Handgrip strength
Handgrip strength will be measured using a handgrip dynamometer.
Measured: 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
Sleep duration will be recorded (format: hh:mm:ss).
Measured: During hospital stay or during home-based hospitalization.
Sleep quality
The heart rate variability parameter RMSSD (measured in ms) will be assessed during sleep.
Measured: During hospital stay or during home-based hospitalization.
Energy expenditure
Energy expenditure (kcal) will be assessed in with a Firstbeat device.
Measured: 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
Number of readmissions of each patient will be registered using the information from the medical records.
Measured: 3 months, 6 months, and 12 months post-discharge.
Rate of falls
The number of falls for each patient will be recorded through follow-up phone calls.
Measured: 3 months, 6 months, and 12 months post-discharge.
Incidence of mortality
Number of deaths will be registered using the information from the medical records.
Measured: 3 months, 6 months, and 12 months post-discharge.
Rate of emergency visits
Number of emergency visits will be registered using the information from the medical records.
Measured: 3 moths, 6 months, and 12 months post-discharge.
Prescribed pharmacologic treatment
All medications prescribed to each patient will be recorded using the information from the medical records.
Measured: 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
Cost-effectiveness will be assessed by calculating the cost per Quality-Adjusted Life Year (QALY) gained.
Measured: At pre-intervention baseline, at 3 months post-discharge, at 6 months post-discharge, and at 12 months post-discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start22 Oct 2026
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute HospitalizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Pública de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07183241
- Sponsor's protocol ID
- PI_2025/34
- Acronym
- H-REACT
- Status last verified
- Oct 2025
- First submitted
- 10 Jun 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparación Entre Ingreso Hospitalario y Hospitalización Domiciliaria y Análisis de Una Intervención Multicomponente en Adultos Mayores: Ensayo Clínico Aleatorizado
- ClinicalTrials.gov ID
- NCT07183241
- Acronym / sponsor ID
- H-REACT / PI_2025/34
- Conditions
- Acute Hospitalization
- Keywords
- acute hospitalization, older adults, exercise, hospital at home, cognitive
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Universidad Pública de NavarraUniversity, hospital or other
- Study start
- 22 Oct 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 19 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Multicomponent intervention | Experimental | Behavioral: Physical exercise and cognitive exercisesPhysical exercise and cognitive exercises |
| Usual care | No intervention | – |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical exercise and cognitive exercisesThe intervention will be based on the Vivifrail program, which is a multicomponent physical exercise program designed specifically for older adults. | Behavioural | Multicomponent intervention |
Primary outcome
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.
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.
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).
Sedentarism
Time frame: During hospital stay or during home-based hospitalization.
Sedentarism will be assessed with a Firstbeat device (format: hh:mm:ss).
12 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical exercise and cognitive exercises in people with Acute Hospitalization, run by Universidad Pública de Navarra at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mikel Izquierdo, Professor (+34 948417876, mikel.izquierdo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.