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

University Hospital of Ferrara

Status: Not yet enrolling

Conditions: Frailty

Treatments: Behavioral: Home-based walking training

Study type: Interventional

Funder types: Other

Identifiers

NCT07118761

189/2024/Sper/AOUFe

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Home-based technology-assisted Exercise

Experimental group

Description:

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.

Treatment:

Behavioral: Home-based walking training

Control

No Intervention group

Description:

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