- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06473168
Mobility Assessment in Multi-morbidity (Multi-mobility)
Walking-related Mobility Assessment in Older People With Multimorbidity
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).
Our 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.
To 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.
The 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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ioannis Vogiatzis, PhD
- Phone Number: +44 (0)191 349 5446
- Email: ioannis.vogiatzis@northumbria.ac.uk
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adults ≥65 years old
- Able and willing to provide informed consent
- Able to read and write in English
- To be mobile (including the use of walking aids)
- 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
Exclusion Criteria:
- Unable to give consent for the study
- Severe mental health problems
- Active malignancy (on chemotherapy/radiotherapy/planned urgent surgery)
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cadence
Time Frame: 7-day real world assessment
|
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.
|
7-day real world assessment
|
|
Stride length
Time Frame: 7-day real world assessment
|
Stride length measured in the real world obtained from the Inertial Measurement Units placed on the lower back and the wrist measured in meters.
|
7-day real world assessment
|
|
Walking speed
Time Frame: 7-day real world assessment
|
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.
|
7-day real world assessment
|
|
Stride duration
Time Frame: 7-day real world assessment
|
Stride duration measured in the real world obtained from the Inertial Measurement Units placed on the lower back and the wrist measured in sec.
|
7-day real world assessment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Turning angle
Time Frame: 7-day real world assessment
|
Measured in the real world obtained from the Inertial Measurement Unit placed on the lower back and the wrist expressed in deg/s.
|
7-day real world assessment
|
|
Daily steps
Time Frame: 7-day real world assessment
|
Measured in the real world obtained from the Inertial Measurement Unit placed on the lower back and the wrist expressed in steps/day.
|
7-day real world assessment
|
|
Sedentarism
Time Frame: 7-day real world assessment
|
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.
|
7-day real world assessment
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Laura Hutchinson, BSc, Northumbria University Newcastle
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Metabolic Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Respiratory Tract Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Lung Diseases
- Urologic Diseases
- Disease Attributes
- Bronchial Diseases
- Renal Insufficiency
- Musculoskeletal Diseases
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Atherosclerosis
- Arrhythmias, Cardiac
- Brain Ischemia
- Bone Diseases
- Bone Diseases, Metabolic
- Chronic Disease
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Coronary Disease
- Bronchiectasis
- Kidney Diseases
- Renal Insufficiency, Chronic
- Lung Diseases, Obstructive
- Pulmonary Disease, Chronic Obstructive
- Vascular Diseases
- Parkinson Disease
- Peripheral Arterial Disease
- Peripheral Vascular Diseases
- Ischemic Attack, Transient
- Atrial Fibrillation
- Osteoporosis
Other Study ID Numbers
- 700448
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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