NCT Number: NCT07118761
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.
Trial opening soon.
Get Notified65 year and older
All sexes
Interventional
Not applicable
University Hospital of Ferrara, Ferrara, Italy
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: From enrollment to the end of treatment at 3 months
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).
Time frame: From enrollment to the end of treatment at 3 months
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
Time frame: From enrollment to the end of treatment at 3 months
The questionnaire includes five Likert-scale multiple choice questions and a visual analog scale to measure the current perception of quality of life.
Time frame: From enrollment to 12 months
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
Time frame: From enrollment to 12 months
Number and rate of all-cause hospitalizations at 12 months. For each patient enrolled we will periodically analyzed the regional dataset to check for any recurrent hospitalization. In case of positive findings, the days elapsed from enrollment to the event will be recorded for additional analyses, as well as the reasons and the diagnoses
Time frame: From enrollment to 12 months
Number and rate of mortality at 12 months. For each patient enrolled we will periodically analyzed the regional dataset to check for any recurrent hospitalization. In case of positive findings, the days elapsed from enrollment to the event will be recorded for additional analyses, as well as the reasons and the diagnoses
Contact information is provided by the study sponsor or research team.
University Hospital of Ferrara
Other
Frailty Status in Hospitalized Persons: Artificial Intelligence-based Detection and Technology-assisted Home-based Empowerment (ART.I.DE.)
Acronym: ARTIDE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07738393
Adherence Interventions, Behavior
Puerto Real, Cádiz, Spain
View Trial DetailsNCT07663955
Acute Exacerbation Chronic Pulmonary Disease, Atrophy
L'Hospitalet de Llobregat, Barcelona, Spain
View Trial DetailsNCT06536985
Behavior, Frailty
Hangzhou, Zhejiang, China
View Trial DetailsNCT07723339
Aging, Behavior
Pamplona, Navarre, Spain
View Trial Details