Ireland
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Starting soon Not applicable

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

NCT07118761 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2025-08-15
Last updated
2025-08-12

Condition(s) studied

Frailty

Investigational drug(s) / intervention(s)

Home-based walking training

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.

Study 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.

Eligibility

Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)

  • Short Physical Performance Battery — From enrollment to the end of treatment at 3 months
    This battery includes three different tests focusing on balance (side-by-side, semi-tandem and tandem position), gait speed (4-meter test) and lower-limb strength (5-time sit-to-stand test). The scale score ranges from 0 (lowest) to 12 (higher) by summing the points obtained in the three tests.

Trial sites (2)

FacilityCityRegionStatus
University Hospital of Ferrara Ferrara Italy
Hospital Universitario Reina Sofia Córdoba Spain
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07118761 on ClinicalTrials.gov ↗ ← All trials in Italy