Hospital-to-Home Rehabilitation Through Exercise and Cognitive Training

NCT07183241 | Not Yet Recruiting DMC

• 1 other identifier: PI_2025/34
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Hospitalization

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Physical function

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

  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.

  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).

  During hospital stay or during home-base hospitalization .

• Sedentarism

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

  During hospital stay or during home-based hospitalization.

Secondary Outcomes (12)

• Health-related quality of life (HRQOL)

  Pre-intervention baseline and immediately after the intervention.

• Heart rate variability

  During hospital stay or during home-based hospitalization.

• 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.

• Sleep quantity

  During hospital stay or during home-based hospitalization.

• Sleep quality

  During hospital stay or during home-based hospitalization.

Study Arms (2)

Multicomponent intervention

EXPERIMENTAL

Physical exercise and cognitive exercises

Behavioral: Physical exercise and cognitive exercises

Usual care

NO INTERVENTION

Interventions

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.

Multicomponent intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Pública de Navarra: lead

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: September 19, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 19, 2025

Record last verified: 2025-06