Neurodegenerative disorders (NDDs) represent an unprecedented public health burden. These disorders are clinically heterogeneous and therapeutically challenging, but advances in discovery science and trial methodology offer hope for translation to new treatments. Against this background, there is an urgent unmet need for biomarkers to aid with early and accurate diagnosis, prognosis and monitoring throughout the care pathway and in clinical trials.

Investigations routinely used in clinical care and trials are often invasive, expensive, time-consuming, subjective and ordinal. Speech data represent a potentially scalable, non-invasive, objective and quantifiable digital biomarker that can be acquired remotely and cost-efficiently using mobile devices, and analysed using state-of-the-art speech signal processing and machine learning approaches. This prospective case–control observational study of multiple NDDs aims to deliver a deeply clinically phenotyped longitudinal speech dataset to facilitate development and evaluation of speech biomarkers.

People living with dementia, motor neuron disease, multiple sclerosis and Parkinson’s disease are eligible to participate. Healthy individuals (including relatives or carers of participants with neurological disease) are also eligible to participate as controls. Participants complete a study app with standardised speech recording tasks (including reading, free speech, picture description and verbal fluency tasks) and patient-reported outcome measures of quality of life and mood (EuroQol-5 Dimension-5 Level, Patient Health Questionnaire 2) every 2 months at home or in clinic. Participants also complete disease severity scales, cognitive screening tests and provide optional samples for blood-based biomarkers at baseline and then 6-monthly. Follow-up is scheduled for up to 24 months. Initially, 30 participants will be recruited to each group. Speech recordings and contemporaneous clinical data will be used to create a dataset for development and evaluation of novel speech-based diagnosis and monitoring algorithms.

Digital App for Speech and Health Monitoring Study was approved by the South Central—Hampshire B Ethics Committee (REC ref. 24/SC/0067), NHS Lothian (R&D ref. 2024/0034) and NHS Forth Valley (R&D ref. FV1494). Results of the study will be submitted for publication in peer-reviewed journals and conferences. Data from the study will be shared with other researchers and used to facilitate speech processing challenges for neurological disorders. Regular updates will be provided on the Anne Rowling Regenerative Neurology Clinic web page and social media platforms.

ClinicalTrials.gov NCT06450418 (pre-results).

The number of people living with multiple long-term conditions (MLTCs or ‘multimorbidity’) is growing. Evidence indicates that exercise-based rehabilitation can improve health-related quality of life and reduce hospital admissions for a number of single long-term conditions. However, it is increasingly recognised that such condition-focused rehabilitation programmes do not meet the needs of people living with MLTCs. The aims for this study were to (1) evaluate the acceptability and feasibility of the newly developed Personalised Exercise Rehabilitation FOR people with Multiple long-term conditions (PERFORM) intervention; (2) assess the feasibility of study methods to inform progression to a definitive randomised controlled trial (RCT) and (3) refine our intervention programme theory.

Semi-structured qualitative interviews were conducted with patients receiving and healthcare practitioners delivering the PERFORM intervention, to seek their experiences of the intervention and taking part in the study. Interviews were analysed thematically, informed by Normalisation Process Theory and the programme theory.

Three UK sites (two acute hospital settings, one community-based healthcare setting).

18 of the 60 PERFORM participants and 6 healthcare professionals were interviewed.

The intervention consisted of 8 weeks of supervised group-based exercise rehabilitation and structured self-care symptom-based support.

All participants and staff interviewed found PERFORM useful for physical and mental well-being and noted positive impacts of participation, although some specific modifications to the intervention delivery and training and study methods were identified. Scheduling, staffing and space limitations were barriers that must be considered for future evaluation and implementation. Key intervention mechanisms identified were social support, patient education, building routines and habits, as well as support from healthcare professionals.

We found the PERFORM intervention to be acceptable and feasible, with the potential to improve the health and well-being of people with MLTCs. The findings of the process evaluation inform the future delivery of the PERFORM intervention and the design of our planned full RCT. A definitive trial is needed to assess the clinical and cost-effectiveness.

ISRCTN68786622.

Existing exercise-based rehabilitation services, such as cardiac and pulmonary rehabilitation, are traditionally commissioned around single long-term conditions (LTCs) and therefore may not meet the complex needs of adults with multiple long-term conditions (MLTCs) or multimorbidity. The aim of this study was to assess the feasibility and acceptability of the newly developed personalised exercise-rehabilitation programme for people with multiple long-term conditions (PERFORM) and the trial methods.

A parallel two-group mixed-methods feasibility randomised controlled trial (RCT) with embedded process and economic evaluation.

Three UK sites (two acute hospital settings, one community-based healthcare setting).

60 adults with MLTCs (defined as the presence of ≥2 LTCs) with at least one known to benefit from exercise therapy were randomised 2:1 to PERFORM intervention plus usual care (PERFORM group) or usual care alone (control group).

The intervention consisted of 8 weeks of supervised group-based exercise rehabilitation and structured self-care symptom-based support.

Primary feasibility outcomes included: trial recruitment (percentage of a target of 60 participants recruited within 4.5 months), retention (percentage of participants with complete EuroQol data at 3 months) and intervention adherence (percentage of intervention group attending ≥60% sessions). Other feasibility measures included completion of outcome measures at baseline (pre-randomisation), 3 months post-randomisation (including patient-reported outcomes, exercise capacity and collection of health and social care resource use) and intervention fidelity.

Target recruitment (40 PERFORM group, 20 control group) was met within the timeframe. Participants were 57% women with a mean (SD) age of 62 (13) years, body mass index of 30.8 (8.0) kg/m² and a median of 4 LTCs (most common: diabetes (41.7%), hypertension (38.3%), asthma (36.7%) and a painful condition (35.0%)). We achieved EuroQol outcome retention of 76.7% (95% CI: 65.9% to 87.1%; 46/60 participants) and intervention adherence of 72.5% (95% CI: 56.3% to 84.4%; 29/40 participants). Data completion for attendees was over 90% for 11/18 outcome measures.

Our findings support the feasibility and rationale for delivering the PERFORM comprehensive self-management and exercise-based rehabilitation intervention for people living with MLTCs and progression to a full multicentre RCT to formally assess clinical effectiveness and cost-effectiveness.

ISRCTN68786622.