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ClinicalTrials.gov ID

NCT07118761

Lead Sponsor

University Hospital of FerraraOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

120Estimated

Last Update Posted

Aug 12, 2025Actual

Start Date

Aug 15, 2025Estimated

Primary Completion Date

Jun 14, 2027Estimated

Completion Date

Jul 14, 2028Estimated

Official Title

Frailty Status in Hospitalized Persons: Artificial Intelligence-based Detection and Technology-assisted Home-based Empowerment (ART.I.DE.)

Brief Summary

This project, that lays in Health Ageing mission promoted by European Commission, aims to address the issue of frailty, a condition that poses the elderlies to increased vulnerability, deconditioning, and, ultimately, loss of independence. Frail people are exposed to a significant increase in mortality, hospitalizations and falls, with high burden for families and for the National Health Service (NHS). Nowadays, the detection of frailty is performed with more than 75 validated measures including questionnaires, scales and technologies. Moreover, frailty is usually not properly addressed, due to the limited resources in terms of personnel and programs in the NHS, and the frail patient is at high risk to be institutionalized and to definitely lose his functional independence. The project here proposed aims to address these topics, by combining clinical, rehabilitation, and engineering expertise in a unique team.

Indeed, the projects aims to empower the frail people with an home-based app-guided rehabilitation program. In order to easily develop a largely tested home-based walking program, we aim to design and develop an application, compatible with any device, that will enable each person to easily exercise at home just few minutes per day. Through a randomized-controlled clinical trial, we will verify the effectiveness of the rehabilitation program on frailty status, in promoting patients' independence, quality of life and ARTIDE score.

• Frailty

• Home-based walking training

Ages Eligible for Study

Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• Frail condition as determined by a Fried Frailty Score equal or more than 2,
• Barthel Index > 60
• Ability to ambulate also with assistance
• Ability to communicate with the research team
• Ability to use a smartphone or a tablet.

Exclusion Criteria:

• terminal illness;
• life-threatening conditions;
• absolute contraindications to exercise training (e.g. fracture);
• severe cognitive decline identified by a Mini-mental status examination < 18;
• incapability or unwillingness to provide informed consent.

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Single

Lead Sponsor

University Hospital of FerraraOTHER

Collaborators

Università degli Studi di FerraraOTHER

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