FrailtyARTIDENCT07118761
Home-based Empowerment Through Physical Exercise Assisted by Technology for Frail Patients
A study testing Home-based walking training in people with Frailty, run by University Hospital of Ferrara at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frailty
- What is being tested?
- Home-based walking training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 15 Aug 2025to 14 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Italy1 site
University Hospital of Ferrara
Ferrara, 44124
Nicola Lamberti, 00390532236187, nicola.lamberti@unife.it
Fabio Manfredini, MD, PhD
Spain1 site
Hospital Universitario Reina Sofia
Córdoba, 14004
Pablo Jesus Lopez-Soto, PhD, 0034957212013, n82losop@uco.es
Pablo Jesus Lopez-Soto, PhD
About this study
Official title: Frailty Status in Hospitalized Persons: Artificial Intelligence-based Detection and Technology-assisted Home-based Empowerment (ART.I.DE.)
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
- Being tested
- Home-based walking training
- Keywords
- Exercise, Technology, Home-based training, Elderly, Frailty
- Medical subject headings
- Frailty, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based walking trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Home-based walking training |
| Control | No intervention | Patients enrolled in this group will receive usual care, including traditional home rehabilitation, if needed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 3 months
Secondary outcomes (6)
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).
Measured: From enrollment to the end of treatment at 3 months
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
Measured: From enrollment to the end of treatment at 3 months
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.
Measured: From enrollment to the end of treatment at 3 months
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
Measured: From enrollment to 12 months
All-cause hospitalizations
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
Measured: From enrollment to 12 months
Survival rate
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
Measured: From enrollment to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start15 Aug 2025 (estimated)
- Primary completion14 Jun 2027 (estimated)
- Study completion14 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of Ferrara
- Sponsor type
- University, hospital or other
- Collaborators
- Università degli Studi di Ferrara
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07118761
- Sponsor's protocol ID
- 189/2024/Sper/AOUFe
- Acronym
- ARTIDE
- Status last verified
- May 2025
- First submitted
- 5 Aug 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The dataset generated from the study will be publicly available in a web repository
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frailty Status in Hospitalized Persons: Artificial Intelligence-based Detection and Technology-assisted Home-based Empowerment (ART.I.DE.)
- ClinicalTrials.gov ID
- NCT07118761
- Acronym / sponsor ID
- ARTIDE / 189/2024/Sper/AOUFe
- Conditions
- Frailty
- Keywords
- Exercise, Technology, Home-based training, Elderly, Frailty
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital of FerraraUniversity, hospital or other
- Collaborators
- Università degli Studi di Ferrara
- Study start
- 15 Aug 2025 (estimated)
- Primary completion
- 14 Jun 2027 (estimated)
- Study completion
- 14 Jul 2028 (estimated)
- First posted
- 12 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home-based technology-assisted Exercise | Experimental | Behavioral: Home-based walking trainingPatients 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. |
| Control | No intervention | –Patients enrolled in this group will receive usual care, including traditional home rehabilitation, if needed. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-based walking trainingPatients 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. | Behavioural | Home-based technology-assisted Exercise |
Primary outcome
Short Physical Performance Battery
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.
6 secondary outcomes
Barthel Index
Time frame: From enrollment to the end of treatment at 3 months
2-minute walking test
Time frame: From enrollment to the end of treatment at 3 months
Quality of life through EQ-5D-5L questionnaire
Time frame: From enrollment to the end of treatment at 3 months
Number of falls
Time frame: From enrollment to 12 months
All-cause hospitalizations
Time frame: From enrollment to 12 months
Survival rate
Time frame: From enrollment to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Individual participant dataSharing planned: Yes. The dataset generated from the study will be publicly available in a web repository
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-based walking training in people with Frailty, run by University Hospital of Ferrara at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicola Lamberti, PhD (00390532236187, nicola.lamberti@unife.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Physical Performance Battery (time frame: From enrollment to the end of treatment at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.