Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2026-03-29 @ 5:56 PM
Study NCT ID:
NCT06473168
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mobility Assessment in Multi-morbidity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D001249', 'term': 'Asthma'}, {'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D001987', 'term': 'Bronchiectasis'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002546', 'term': 'Ischemic Attack, Transient'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D002545', 'term': 'Brain Ischemia'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 55}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-18', 'studyFirstSubmitDate': '2024-06-07', 'studyFirstSubmitQcDate': '2024-06-18', 'lastUpdatePostDateStruct': {'date': '2024-06-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cadence', 'timeFrame': '7-day real world assessment', 'description': 'Walking cadence measured in the real world obtained from the Inertial Measurement Units placed on the lower back and the wrist measured in steps/minute.'}, {'measure': 'Stride length', 'timeFrame': '7-day real world assessment', 'description': 'Stride length measured in the real world obtained from the Inertial Measurement Units placed on the lower back and the wrist measured in meters.'}, {'measure': 'Walking speed', 'timeFrame': '7-day real world assessment', 'description': 'Walking speed measured in the real world obtained from the Inertial Measurement Units placed on the lower back and the wrist measured in m/s.'}, {'measure': 'Stride duration', 'timeFrame': '7-day real world assessment', 'description': 'Stride duration measured in the real world obtained from the Inertial Measurement Units placed on the lower back and the wrist measured in sec.'}], 'secondaryOutcomes': [{'measure': 'Turning angle', 'timeFrame': '7-day real world assessment', 'description': 'Measured in the real world obtained from the Inertial Measurement Unit placed on the lower back and the wrist expressed in deg/s.'}, {'measure': 'Daily steps', 'timeFrame': '7-day real world assessment', 'description': 'Measured in the real world obtained from the Inertial Measurement Unit placed on the lower back and the wrist expressed in steps/day.'}, {'measure': 'Sedentarism', 'timeFrame': '7-day real world assessment', 'description': 'Measured in the real world obtained from the Inertial Measurement Unit placed on the lower back and the wrist indicating time spent in different types of activities such as sitting down, lying, and walking expressed in minutes per day.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Arthritis', 'Asthma', 'Atrial Fibrillation', 'Bronchiectasis', 'Cancer', 'Chronic Kidney Diseases', 'Chronic Obstructive Pulmonary Disease', 'Coronary Heart Disease', 'Anxiety', 'Depression', 'Diabetes Mellitus', 'Heart Failure', 'Hypertension', 'Osteoporosis', 'Parkinson Disease', 'Peripheral Vascular Disease', 'Stroke', 'Transient Ischemic Attack']}, 'descriptionModule': {'briefSummary': "Multimorbidity (the presence of two or more coexisting long-term conditions) is a significant challenge facing the NHS, especially given UK's ageing population and the association with high levels of illness burden and healthcare costs. Over 50% of adults \\>65 years have multiple long-term conditions (MLTCs).\n\nOur group has validated a broad range of algorithms applied to single wearable sensors that have the potential to capture walking-related mobility outcomes (such as walking cadence and walking speed) accurately and reliably during activities of daily living across five single long-term conditions. These algorithms, however, cannot be readily applied to people with MLTCs because the effect of multimorbidity on mobility is amplified compared to single long-term conditions secondary to a greater number of complications and sequelae. Accordingly, the aim of this study is to validate algorithms that would allow robust estimation of walking-related mobility outcomes during daily life activities in MLTCs.\n\nTo meet our objectives, the investigators will perform: i) laboratory-based technical validation of existing and newly developed algorithms for walking-related mobility outcome detection; ii) unsupervised real-life validation of selected algorithms; and iii) examination of how well the validated walking-related mobility outcomes reflect global and disease specific characteristics in older adults with multimorbidity. The investigators will adopt an integrated patient-centric approach where patients with MLTCs will be engaged early in the project to provide input of their perception and concerns regarding mobility limitation in daily life activities.\n\nThe investigators aim to recruit 55 older adults (\\>65 years), men and women, with multiple long-term conditions with the following inclusion criteria: having two or more of the following conditions including osteoarthritis, rheumatoid arthritis, osteoporosis, type 2 diabetes, depression and/or anxiety, hypertension, coronary heart disease, heart failure, atrial fibrillation, chronic obstructive pulmonary disease, asthma, bronchiectasis, chronic kidney disease, cancer, or stroke within the last 5 years."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients will be recruited from outpatient clinics within the Newcastle upon Tyne Hospitals NHS Foundation Trust.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults ≥65 years old\n* Able and willing to provide informed consent\n* Able to read and write in English\n* To be mobile (including the use of walking aids)\n* Two or more of the following long terms conditions: Arthritis, Asthma, Atrial fibrillation, Bronchiectasis, Cancer, Chronic kidney disease, Chronic obstructive pulmonary disease, Coronary heart disease, Anxiety, Depression, Diabetes mellitus, Heart failure, Hypertension, Osteoporosis, Parkinson's disease, Peripheral vascular disease, Stroke or transient ischaemic attack\n\nExclusion Criteria:\n\n* Unable to give consent for the study\n* Severe mental health problems\n* Active malignancy (on chemotherapy/radiotherapy/planned urgent surgery)"}, 'identificationModule': {'nctId': 'NCT06473168', 'acronym': 'Multi-mobility', 'briefTitle': 'Mobility Assessment in Multi-morbidity', 'organization': {'class': 'OTHER', 'fullName': 'Northumbria University'}, 'officialTitle': 'Walking-related Mobility Assessment in Older People With Multimorbidity', 'orgStudyIdInfo': {'id': '700448'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ioannis Vogiatzis, PhD', 'role': 'CONTACT', 'email': 'ioannis.vogiatzis@northumbria.ac.uk', 'phone': '+44 (0)191 349 5446'}], 'overallOfficials': [{'name': 'Laura Hutchinson, BSc', 'role': 'STUDY_CHAIR', 'affiliation': 'Northumbria University Newcastle'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northumbria University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Newcastle University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Rehabilitation Sciences', 'investigatorFullName': 'Ioannis Vogiatzis', 'investigatorAffiliation': 'Northumbria University'}}}}