Background: The development of optimal strategies to treat impaired mobility related to ageing and chronic disease requires better ways to detect and measure it. Digital health technology, including body worn sensors, has the potential to directly and accurately capture real-world mobility. Mobilise-D consists of 34 partners from 13 countries who are working together to jointly develop and implement a digital mobility assessment solution to demonstrate that real-world digital mobility outcomes have the potential to provide a better, safer, and quicker way to assess, monitor, and predict the efficacy of new interventions on impaired mobility. The overarching objective of the study is to establish the clinical validity of digital outcomes in patient populations impacted by mobility challenges, and to support engagement with regulatory and health technology agencies towards acceptance of digital mobility assessment in regulatory and health technology assessment decisions. Methods/design: The Mobilise-D clinical validation study is a longitudinal observational cohort study that will recruit 2400 participants from four clinical cohorts. The populations of the Innovative Medicine Initiative-Joint Undertaking represent neurodegenerative conditions (Parkinson’s Disease), respiratory disease (Chronic Obstructive Pulmonary Disease), neuro-inflammatory disorder (Multiple Sclerosis), fall-related injuries, osteoporosis, sarcopenia, and frailty (Proximal Femoral Fracture). In total, 17 clinical sites in ten countries will recruit participants who will be evaluated every six months over a period of two years. A wide range of core and cohort specific outcome measures will be collected, spanning patient-reported, observer-reported, and clinician-reported outcomes as well as performance-based outcomes (physical measures and cognitive/mental measures). Daily-living mobility and physical capacity will be assessed directly using a wearable device. These four clinical cohorts were chosen to obtain generalizable clinical findings, including diverse clinical, cultural, geographical, and age representation. The disease cohorts include a broad and heterogeneous range of subject characteristics with varying chronic care needs, and represent different trajectories of mobility disability. Discussion: The results of Mobilise-D will provide longitudinal data on the use of digital mobility outcomes to identify, stratify, and monitor disability. This will support the development of widespread, cost-effective access to optimal clinical mobility management through personalised healthcare. Further, Mobilise-D will provide evidence-based, direct measures which can be endorsed by regulatory agencies and health technology assessment bodies to quantify the impact of disease-modifying interventions on mobility. Trial registration: ISRCTN12051706.

Objective: Post-COVID syndrome involves prolonged symptoms with multisystem and functional impairment lasting ≥12 weeks after acute coronavirus disease 2019 (COVID-19). We aimed to determine the efficacy of exercise-based rehabilitation interventions, either face-to-face or remote, compared to usual care in individuals experiencing post-COVID syndrome following a hospitalisation with acute COVID-19.Design: This single-blind randomised controlled trial compared two exercise-based rehabilitation interventions (face-to-face or remote) to usual care in participants with post-COVID syndrome following a hospitalisation. The interventions were either a face-to-face or remote 8-week programme of individually prescribed exercise and education. The primary outcome was the change in Incremental Shuttle Walking Test (ISWT) following 8 weeks of intervention (either face-to-face or remote) compared to usual care. Other secondary outcomes were measured including health-related quality of life (HRQoL), and exploratory outcomes included lymphocyte immunotyping.Results: 181 participants (55% male, mean±sdage 59±12 years, length of hospital stay 12±19 days) were randomised. There was an improvement in the ISWT distance following face-to-face rehabilitation (mean 52 m, 95% CI 19–85 m; p=0.002) and remote rehabilitation (mean 34 m, 95% CI 1–66 m; p=0.047) compared to usual care alone. There were no differences between groups for HRQoL self-reported symptoms. Analysis of immune markers revealed significant increases in naïve and memory CD8⁺T-cells following face-to-face rehabilitationversususual care alone (p<0.001, n=31).Conclusion: Exercise-based rehabilitation improved short-term exercise capacity in post-COVID syndrome following an acute hospitalisation and showed potential for beneficial immunomodulatory effects.

Background: Despite improvements in pulmonary function following lung transplantation (LTx), physical activity levels remain significantly lower than the general population. To date, there is little research investigating interventions to improve daily physical activity in LTx recipients. This study assessed the feasibility and acceptability of a novel, 12-weeks physical activity tele-coaching (TC) intervention in LTx recipients. Methods: Lung transplant recipients within 2 months of hospital discharge were recruited and randomised (1:1) to TC or usual care (UC). TC consists of a pedometer and smartphone app, allowing transmission of activity data to a platform that provides feedback, activity goals, education, and contact with the researcher as required. Recruitment and retention, occurrence of adverse events, intervention acceptability and usage were used to assess feasibility. Results: Key criteria for progressing to a larger study were met. Of the 15 patients eligible, 14 were recruited and randomised to TC or UC and 12 completed (67% male; mean ± SD age; 58 ± 7 years; COPD n = 4, ILD n = 6, CF n = 1, PH n = 1): TC ( n = 7) and UC ( n = 5). TC was well accepted by patients, with 86% indicating that they enjoyed taking part. Usage of the pedometer was excellent, with all patients wearing it for over 90% of days and rating the pedometer and telephone contact as the most vital aspects. There were no adverse events related to the intervention. After 12 weeks, only TC displayed improvements in accelerometry steps/day (by 3475 ± 3422; p = .036) and movement intensity (by 153 ± 166 VMU; p = .019), whereas both TC and UC groups exhibited clinically important changes in physical SF-36 scores (by 11 ± 14 and 7 ± 9 points, respectively). Conclusion: TC appears to be a feasible, safe, and well-accepted intervention in LTx.

In response to #COVID19, healthcare professionals should scale up virtual consultations for assessing core patient-reported outcomes and providing home-based rehabilitation programmes #COPDhttps://bit.ly/30gQEpG