About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
terminal illness;
life-threatening conditions;
absolute contraindications to exercise training (e.g. fracture);
severe cognitive decline identified by a Mini-mental status examination < 18;
Trial design
Parallel
Treatments tested in this trial
Home-based walking training
BehavioralPatients 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Barthel Index
Assess the functional independence in activities of daily living. This ordinal scale includes 10 items and provides a score ranging from 0 (total dependence) to 100 (total independence).
2-minute walking test
Patients will be instructed to walk on a 20-meter corridor aiming at covering as much distance as possible in two minutes. Patients will be allowed to slow down the pace and/or stop in case of fatigue and symptoms. The total distance covered will be collected, as well the 0-10 rate of perceived exertion
Quality of life through EQ-5D-5L questionnaire
The questionnaire includes five Likert-scale multiple choice questions and a visual analog scale to measure the current perception of quality of life.
Number of falls
Rate of falls will be collected by giving to the patients' caregiver (when possible) or directly to the patient a small diary to report the total number of falls experienced
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital of Ferrara
Lead sponsor
Università degli Studi di Ferrara
Collaborator
This trial is not recruiting at the moment. You can still explore other options: