Hospital-to-Home Rehabilitation Through Exercise and Cognitive Training

Not Applicable

Not yet recruiting

• Conditions: Acute Hospitalization

• Registration Number: NCT07183241
• Lead Sponsor: Universidad Pública de Navarra

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-10
• Study First Submitted QC: 2025-09-17
• Last Update Submitted: 2025-09-17
• Study First Posted: 2025-09-19
• Last Update Posted: 2025-09-19
• Study Start: 2025-10-01
• Primary Completion: 2026-12
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Physical function	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	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	During hospital stay or during home-base hospitalization .	Physical activity will be assessed with a Firstbeat device (format: hh:mm:ss).
Sedentarism	During hospital stay or during home-based hospitalization.	Sedentarism will be assessed with a Firstbeat device (format: hh:mm:ss).

Secondary Outcome Measures

Name	Time	Method
Cost-effectiveness	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.
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.
Heart rate variability	During hospital stay or during home-based hospitalization.	Heart rate variability will be assessed usign a Firstbeat device.
Handgrip strength	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.
Sleep quantity	During hospital stay or during home-based hospitalization.	Sleep duration will be recorded (format: hh:mm:ss).
Sleep quality	During hospital stay or during home-based hospitalization.	The heart rate variability parameter RMSSD (measured in ms) will be assessed during sleep.
Energy expenditure	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.
Rate of hospital readmissions	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.
Rate of falls	3 months, 6 months, and 12 months post-discharge.	The number of falls for each patient will be recorded through follow-up phone calls.
Incidence of mortality	3 months, 6 months, and 12 months post-discharge.	Number of deaths will be registered using the information from the medical records.
Rate of emergency visits	3 moths, 6 months, and 12 months post-discharge.	Number of emergency visits will be registered using the information from the medical records.
Prescribed pharmacologic treatment	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.