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

Official title

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

Overview

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.

Interventions

• Behavioral 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.

Primary outcome measures

• Short Physical Performance Battery [Time frame: From enrollment to the end of treatment at 3 months]

Secondary outcome measures (6)

• Barthel Index [Time frame: From enrollment to the end of treatment at 3 months]
• 2-minute walking test [Time frame: From enrollment to the end of treatment at 3 months]
• Quality of life through EQ-5D-5L questionnaire [Time frame: From enrollment to the end of treatment at 3 months]
• Number of falls [Time frame: From enrollment to 12 months]
• All-cause hospitalizations [Time frame: From enrollment to 12 months]
• Survival rate [Time frame: From enrollment to 12 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Italy · 1 center

• University Hospital of Ferrara — Ferrara

Spain · 1 center

• Hospital Universitario Reina Sofia — Córdoba

Identifiers

NCT: NCT07118761 · 189/2024/Sper/AOUFe

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗