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

ConditionFrailty
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversity Hospital of Ferrara

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Home-based technology-assisted ExerciseExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

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.

Time frame
From enrollment to the end of treatment at 3 months

Secondary outcomes

1

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).

Time frame
From enrollment to the end of treatment at 3 months
2

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

Time frame
From enrollment to the end of treatment at 3 months
3

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.

Time frame
From enrollment to the end of treatment at 3 months
4

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

Time frame
From enrollment to 12 months

Other outcomes

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: