Up to 65% of people with multiple sclerosis (PwMS) develop cognitive deficits, which hampers participation in day-to-day life and ultimately reduces quality of life (QoL). Treatment of symptoms at a late stage can lead to cognitive impairment and unemployment, highlighting the need for preventative interventions in PwMS. Presenting a combination of exercise and cognitive training early might postpone cognitive decline.

This study highlights one intervention of the Don't be late! study, which aims to evaluate the (cost-)effectiveness of an innovative preventative intervention, aimed at postponing cognitive decline, compared to enhanced usual care in improving health-related QoL (HRQoL).

Randomised controlled trial including 270 PwMS with mild cognitive impairment, who have paid employment ≥ 12 hours per week and are able to participate in physical exercise (Expanded Disability Status Scale < 6.0). Participants are assigned to either a lifestyle intervention combining one-on-one personal fitness, mental coaching, dietary advice, and cognitive training, adjusted to the goals and level of the participant or a control group receiving general information about cognitive impairment in MS and receiving care as usual. Intervention duration is four months, with short-term and long-term follow-up measurements at 10 and 16 months, respectively. The overarching study also includes a work-focused intervention. The primary outcome measure will be HRQoL. Secondary outcomes include cognition, structural and functional brain changes, work related outcomes, physical functioning, psychological functioning, and societal costs. Semi-structured interviews and focus groups with stakeholders will be organised to qualitatively reflect on the process and outcome of the interventions.

This study seeks to prevent (further) cognitive decline due to MS by introducing tailor-made interventions at an early stage of cognitive symptoms, thereby maintaining or improving HRQoL. Qualitative analyses will be performed to allow successful implementation into clinical practice.