Ignite Creation Date:
2025-12-24 @ 1:09 PM
Ignite Modification Date:
2025-12-29 @ 3:56 PM
Study NCT ID:
NCT07118761
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-12
First Post:
2025-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Home-based Empowerment Through Physical Exercise Assisted by Technology for Frail Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073496', 'term': 'Frailty'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2028-07-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-05', 'studyFirstSubmitDate': '2025-08-05', 'studyFirstSubmitQcDate': '2025-08-05', 'lastUpdatePostDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Short Physical Performance Battery', 'timeFrame': 'From enrollment to the end of treatment at 3 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Barthel Index', 'timeFrame': 'From enrollment to the end of treatment at 3 months', 'description': '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).'}, {'measure': '2-minute walking test', 'timeFrame': 'From enrollment to the end of treatment at 3 months', 'description': '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'}, {'measure': 'Quality of life through EQ-5D-5L questionnaire', 'timeFrame': 'From enrollment to the end of treatment at 3 months', 'description': 'The questionnaire includes five Likert-scale multiple choice questions and a visual analog scale to measure the current perception of quality of life.'}, {'measure': 'Number of falls', 'timeFrame': 'From enrollment to 12 months', 'description': "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"}, {'measure': 'All-cause hospitalizations', 'timeFrame': 'From enrollment to 12 months', 'description': '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'}, {'measure': 'Survival rate', 'timeFrame': 'From enrollment to 12 months', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Exercise', 'Technology', 'Home-based training', 'Elderly', 'Frailty'], 'conditions': ['Frailty']}, 'descriptionModule': {'briefSummary': "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.\n\nIndeed, 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Frail condition as determined by a Fried Frailty Score equal or more than 2,\n* Barthel Index \\> 60\n* Ability to ambulate also with assistance\n* Ability to communicate with the research team\n* Ability to use a smartphone or a tablet.\n\nExclusion Criteria:\n\n* terminal illness;\n* life-threatening conditions;\n* absolute contraindications to exercise training (e.g. fracture);\n* severe cognitive decline identified by a Mini-mental status examination \\< 18;\n* incapability or unwillingness to provide informed consent.'}, 'identificationModule': {'nctId': 'NCT07118761', 'acronym': 'ARTIDE', 'briefTitle': 'Home-based Empowerment Through Physical Exercise Assisted by Technology for Frail Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital of Ferrara'}, 'officialTitle': 'Frailty Status in Hospitalized Persons: Artificial Intelligence-based Detection and Technology-assisted Home-based Empowerment (ART.I.DE.)', 'orgStudyIdInfo': {'id': '189/2024/Sper/AOUFe'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Home-based technology-assisted Exercise', 'description': '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.', 'interventionNames': ['Behavioral: Home-based walking training']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Patients enrolled in this group will receive usual care, including traditional home rehabilitation, if needed.'}], 'interventions': [{'name': 'Home-based walking training', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Home-based technology-assisted Exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44124', 'city': 'Ferrara', 'country': 'Italy', 'contacts': [{'name': 'Nicola Lamberti', 'role': 'CONTACT', 'email': 'nicola.lamberti@unife.it', 'phone': '00390532236187'}, {'name': 'Fabio Manfredini, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Gianluca Colussi, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Elisabetta Pettenuzzo, MSc', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University Hospital of Ferrara', 'geoPoint': {'lat': 44.83804, 'lon': 11.62057}}, {'zip': '14004', 'city': 'Córdoba', 'country': 'Spain', 'contacts': [{'name': 'Pablo Jesus Lopez-Soto, PhD', 'role': 'CONTACT', 'email': 'n82losop@uco.es', 'phone': '0034957212013'}, {'name': 'Pablo Jesus Lopez-Soto, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario Reina Sofia', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}], 'centralContacts': [{'name': 'Nicola Lamberti, PhD', 'role': 'CONTACT', 'email': 'nicola.lamberti@unife.it', 'phone': '00390532236187'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Start date: January 2026 End date: December 2028', 'ipdSharing': 'YES', 'description': 'The dataset generated from the study will be publicly available in a web repository'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital of Ferrara', 'class': 'OTHER'}, 'collaborators': [{'name': 'Università degli Studi di Ferrara', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}