Frailty
Conditions
Keywords
Exercise, Technology, Home-based training, Elderly, Frailty
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.
Interventions
BEHAVIORALHome-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.
Sponsors
Università degli Studi di Ferrara
University Hospital of Ferrara
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Barthel Index | 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). |
| 2-minute walking test | 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 |
| Quality of life through EQ-5D-5L questionnaire | 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. |
| Number of falls | 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 |
| All-cause hospitalizations | 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 |
| Survival rate | 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 |
Countries
Italy, Spain
Contacts
Primary ContactNicola Lamberti, PhD
Outcome results
None listed