ArthritisMulti-mobilityNCT06473168
Mobility Assessment in Multi-morbidity
An observational study of Arthritis and Asthma, run by Northumbria University.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Arthritis, Asthma, Atrial Fibrillation
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Patients will be recruited from outpatient clinics within the Newcastle upon Tyne Hospitals NHS Foundation Trust.
Who may be able to join
- 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
Who cannot join
- Unable to give consent for the study
- Severe mental health problems
- Active malignancy (on chemotherapy/radiotherapy/planned urgent surgery)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read more
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.
- Conditions
- Arthritis, Asthma, Atrial Fibrillation, Bronchiectasis, Cancer, Chronic Kidney Diseases
- Medical subject headings
- Arthritis, Asthma, Atrial Fibrillation, Bronchiectasis, Neoplasms, Renal Insufficiency, Chronic, Pulmonary Disease, Chronic Obstructive, Coronary Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Cadence
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.
Measured: 7-day real world assessment
Stride length
Stride length measured in the real world obtained from the Inertial Measurement Units placed on the lower back and the wrist measured in meters.
Measured: 7-day real world assessment
Walking speed
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.
Measured: 7-day real world assessment
Stride duration
Stride duration measured in the real world obtained from the Inertial Measurement Units placed on the lower back and the wrist measured in sec.
Measured: 7-day real world assessment
Secondary outcomes (3)
Turning angle
Measured in the real world obtained from the Inertial Measurement Unit placed on the lower back and the wrist expressed in deg/s.
Measured: 7-day real world assessment
Daily steps
Measured in the real world obtained from the Inertial Measurement Unit placed on the lower back and the wrist expressed in steps/day.
Measured: 7-day real world assessment
Sedentarism
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.
Measured: 7-day real world assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start1 Dec 2024 (estimated)
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthritisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Collaborators
- Newcastle University
- Responsible party
- Principal investigator, Ioannis Vogiatzis, Northumbria University
- Investigators
- Laura Hutchinson, BSc, Study chair, Northumbria University Newcastle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06473168
- Sponsor's protocol ID
- 700448
- Acronym
- Multi-mobility
- Status last verified
- Jun 2024
- First submitted
- 7 Jun 2024
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Walking-related Mobility Assessment in Older People With Multimorbidity
- ClinicalTrials.gov ID
- NCT06473168
- Acronym / sponsor ID
- Multi-mobility / 700448
- Conditions
- Arthritis, Asthma, Atrial Fibrillation, Bronchiectasis, Cancer, Chronic Kidney Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Collaborators
- Newcastle University
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 25 Jun 2024 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients will be recruited from outpatient clinics within the Newcastle upon Tyne Hospitals NHS Foundation Trust.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Unable to give consent for the study
- Severe mental health problems
- Active malignancy (on chemotherapy/radiotherapy/planned urgent surgery)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
3 secondary outcomes
Turning angle
Time frame: 7-day real world assessment
Daily steps
Time frame: 7-day real world assessment
Sedentarism
Time frame: 7-day real world assessment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
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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. This study is not recruiting at the moment.
Laura Hutchinson, BSc study chair
Northumbria University Newcastle
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis and Asthma, run by Northumbria University.
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 3 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: status not confirmed, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ioannis Vogiatzis, PhD (+44 (0)191 349 5446, ioannis.vogiatzis@northumbria.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cadence (time frame: 7-day real world assessment). The study lists 4 primary outcomes in all. 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 25 Jun 2024.