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

NCT07118761 | Not Yet Recruiting

• 1 other identifier: 189/2024/Sper/AOUFe
• Study Type: interventional
• Target: 120
• Locations: 2 countries
• Sites: 2

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

Keywords

Exercise; Technology; Home-based training; Elderly; Frailty

Outcome Measures

Primary Outcomes (1)

• Short Physical Performance Battery

  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.

  From enrollment to the end of treatment at 3 months

Secondary Outcomes (6)

• Barthel Index

  From enrollment to the end of treatment at 3 months

• 2-minute walking test

  From enrollment to the end of treatment at 3 months

• Quality of life through EQ-5D-5L questionnaire

  From enrollment to the end of treatment at 3 months

• Number of falls

  From enrollment to 12 months

• All-cause hospitalizations

  From enrollment to 12 months

Study Arms (2)

Home-based technology-assisted Exercise

EXPERIMENTAL

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.

Behavioral: Home-based walking training

Control

NO INTERVENTION

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

Interventions

Home-based walking training 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.

Home-based technology-assisted Exercise

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital of Ferrara: lead
• Università degli Studi di Ferrara: collaborator

Study Sites (2)

University Hospital of Ferrara

Ferrara, 44124, Italy

Location

Hospital Universitario Reina Sofia

Córdoba, 14004, Spain

Location

MeSH Terms

Conditions

Frailty; Motor Activity

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Central Study Contacts

Nicola Lamberti, PhD

CONTACT

00390532236187; nicola.lamberti@unife.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 12, 2025
• Study Start: August 15, 2025
• Primary Completion (Estimated): June 14, 2027
• Study Completion (Estimated): July 14, 2028
• Last Updated: August 12, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Start date: January 2026 End date: December 2028

Locations

IT (1); ES (1)