Chronic obstructive pulmonary disease (COPD), Parkinson’s disease (PD), multiple sclerosis (MS), proximal femoral fracture (PFF), congestive heart failure (CHF) Other
Conditions
Interventions
120 participants representing the disease cohorts of interest to MOBILISE-D partners will be recruited from six different groups: chronic obstructive pulmonary disease (COPD), Parkinson’s disease (PD)
Sponsors
Newcastle upon Tyne Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: All groups: 1. Able to walk 4 meters independently with or without walking aids 2. Able to give informed consent 3. Willingness to wear the sensor set-ups during the study 4. Shoe size 36 (3 UK) or above 5. Able to read and write in first language in the respective country 6. MoCA >154 7. Available for home visit/office during study period Each disease cohort has specific inclusion criteria: COPD: 1. =45 years of age 2. Diagnosis of COPD (post-bronchodilator forced expiratory volume in the first second (FEV1) to forced vital capacity (FVC) ratio <0.70) 3. Clinical stability, defined as at least 4 weeks without antibiotics and/or oral corticosteroids to treat either a moderate or severe exacerbation 4. Current or ex-smokers with a smoking history equivalent to at least 10 pack years (1 pack year = 20 cigarettes smoked per day for 1 year) PD: 1. Aged 18+ years 2. Diagnosis of PD according to the Movement Disorders Society criteria MS: 1. Aged 18+ years 2. Diagnosis of MS based on the revised McDonald’s criteria PFF: 1. 65+ years of age 2. Surgical treatment (fixation or arthroplasty) for a low-energy fracture of the proximal femur (ICD-10 diagnosis S72.0, S72.1, S72.2) as diagnosed on X-rays of the hip and pelvis within last 12 months CHF: 1. =45 years of age 2. Diagnosis of chronic heart failure NYHA class II-IV HA: 1. 65+ years of age
Exclusion criteria
Exclusion criteria: All groups: 1. The occurrence of any of the following with 3 months prior to inclusion: myocardial infarction, hospitalization for unstable angina, stroke, coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), implantation of a cardiac resynchronization therapy device (CRTD) 2. Current medical condition that could interfere with the patient’s compliance COPD: 1. Having undergone major lung surgery (e.g. lung volume reduction, lung transplant) 2. Having a lung tumor 3. Primary respiratory diseases other than COPD 4. Impaired mobility related to non-COPD causes, as judged by the investigator PD: 1. Impaired mobility related to non-PD causes, as judged by the investigator MS: 1. Impaired mobility related to non-MS causes, as judged by the investigator PFF: 1. Impaired mobility related to non-PFF causes, as judged by the investigator CHF: 1. History of COPD =GOLD III 2. Impaired mobility related to non-CHF causes, as judged by the investigator HA: 1. Neurological, respiratory, cardiac or musculoskeletal conditions affecting the ability to walk independently without a walking aid
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 01/11/2022: Walking speed data in the real-world measured using a single sensor in comparison to walking speed data collected using multi-sensor reference systems in the lab and in the home. The laboratory tasks (45 minutes) and the home environment measurement (2.5 hours unsupervised) take place within 9 days of each other. _____ Previous primary outcome measure: Walking speed in real-world settings, collected via the sensor during a 7-day continual recording of free-living activities in the home environment | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 01/11/2022: Right and left step, stride, turning angle, cadence, distance walked, gait variability and symmetry, and other gait-related outcomes relevant in the real-world measured using a single sensor in comparison to multi-sensor reference systems in the lab and in the home. The laboratory tasks (45 minutes) and the home environment measurement (2.5 hours unsupervised) take place within 9 days of each other. _____ Previous secondary outcome measures: Right and left step, stride, turning angle, cadence, distance walked, gait variability and symmetry, and other gait-related outcomes relevant for assessments in real-world settings, collected via the sensor during a 7-day continual recording of free-living activities in the home environment | — |
Countries
England, Germany, Israel, United Kingdom
Outcome results
None listed