Home-based Empowerment Through Physical Exercise Assisted by Technology for Frail Patients

NCT ID: NCT07118761

Last Updated: 2025-08-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-15
• Study Completion Date: 2028-07-14

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.

Conditions

Frailty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Home-based technology-assisted Exercise

Patients enrolled in this group will undergo an exercise-based intervention at home guided by the ARTIDE app. Each exercise session will encompass 8 walking minutes at home at a fixed slow speed to be repeated twice per day. Every week the speed will be slightly increased to maintain an adequate training stimulus.

Group Type: EXPERIMENTAL

Home-based walking training

Intervention Type: BEHAVIORAL

Patients enrolled in the experimental group will undergo an exercise-based intervention at home guided by a smartphone application. Each exercise session will encompass 8 walking minutes at home at a fixed slow speed to be repeated twice per day. Every week the speed will be slightly increased to maintain an adequate training stimulus.

Control

Patients enrolled in this group will receive usual care, including traditional home rehabilitation, if needed.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Home-based walking training

Patients enrolled in the experimental group will undergo an exercise-based intervention at home guided by a smartphone application. Each exercise session will encompass 8 walking minutes at home at a fixed slow speed to be repeated twice per day. Every week the speed will be slightly increased to maintain an adequate training stimulus.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Università degli Studi di Ferrara

OTHER

Sponsor Role: collaborator

University Hospital of Ferrara

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital of Ferrara

Ferrara, , Italy

Hospital Universitario Reina Sofia

Córdoba, , Spain

Countries

Italy; Spain

Central Contacts

Nicola Lamberti, PhD

Role: CONTACT

nicola.lamberti@unife.it

00390532236187

Facility Contacts

Nicola Lamberti

Role: primary

nicola.lamberti@unife.it

00390532236187

Pablo Jesus Lopez-Soto, PhD

Role: primary

n82losop@uco.es

0034957212013

Other Identifiers

189/2024/Sper/AOUFe

Identifier Type: -

Identifier Source: org_study_id