Mobility Assessment in Multi-morbidity

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 65 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06473168
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Northumbria University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Laura Hutchinson, BSc
Principal Investigator Affiliation Northumbria University Newcastle
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

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

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Ioannis Vogiatzis, PhD

[email protected]

+44 (0)191 349 5446

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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