CClinicalTrials.gg
Not yet recruitingNCT07183241H-REACTUpdated Sep 19, 2025

Hospital-to-Home Rehabilitation Through Exercise and Cognitive Training

An interventional study of Physical exercise and cognitive exercises in Acute Hospitalization, sponsored by Universidad Pública de Navarra. Not yet recruiting. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-09-19.

Sponsored by Universidad Pública de Navarra · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Acute Hospitalization

Browse trials for

Keywords

  • acute hospitalization
  • older adults
  • exercise
  • hospital at home
  • cognitive
03

In context

Motor Activity

2,426 studies on the registry are indexed under Motor Activity; 1,161 are open to participants now.

This study's planned enrollment of 200 is above the median of 60 across 2,118 interventional studies indexed under Motor Activity.

Browse Motor Activity studies →

Lead sponsor

Universidad Pública de Navarra is the lead sponsor of 13 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Multicomponent intervention

    Physical exercise and cognitive exercises

    Behavioral: Physical exercise and cognitive exercises

  • No intervention
    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.

06

What researchers measure

Primary outcomes

  1. Physical function

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

    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.

  2. Cognitive function

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

  3. Physical activity

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

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

  4. Sedentarism

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

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

Secondary outcomes

  1. 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.

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

  2. Heart rate variability

    Heart rate variability will be assessed usign a Firstbeat device.

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

  3. Handgrip strength

    Handgrip strength will be measured using a handgrip dynamometer.

    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.

  4. Sleep quantity

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

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

  5. Sleep quality

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

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

  6. Energy expenditure

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

    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.

  7. Rate of hospital readmissions

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

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

  8. Rate of falls

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

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

  9. Incidence of mortality

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

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

  10. Rate of emergency visits

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

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

  11. Prescribed pharmacologic treatment

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

    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.

  12. Cost-effectiveness

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

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07183241
Lead sponsor
Universidad Pública de Navarra
Responsible party
Sponsor
First posted
Sep 19, 2025
Start date
Oct 2025 (estimated)
Primary completion
Dec 2026 (estimated)
Completion
Jun 2027 (estimated)
Last update
Sep 19, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion