Objective: To determine the feasibility and preliminary efficacy of a remote exercise intervention in prodromal Parkinson’s disease (PD).

Background: Disease-slowing interventions have been ineffective in clinically manifest PD but may be successful in prodromal PD, when pathology is limited. People with an isolated REM sleep behaviour disorder (iRBD) have a high risk to develop clinically manifest disease and are therefore considered to have probable prodromal PD. There is converging evidence that exercise may slow the progression of the pathological processes of PD.

Method: Slow-SPEED-NL is a double-blind randomized controlled trial of 24 months comparing an exercise intervention vs. an active control program. We will include 110 people with iRBD (ICSD-3 criteria) in the Netherlands. All participants will use a dedicated smartphone app that motivates participants to increase their step count and volume of moderate-to-vigorous physical activity (MVPA). Participants will be randomly assigned to either an active control group —with an increase in exercise levels up to 10%, relative to participants’ own baseline levels— or an intervention group —with an increase in exercise levels up to 100%. Participants will be monitored remotely in their own home environment using a study smartwatch and their own smartphone. Furthermore, participants will have two center visits for blood drawing and 3T-brain MRI assessments, at baseline and at 24 months.

Results: The primary endpoint is the longitudinal change in step count, which will be measured remotely using the study smartwatch. Secondary endpoints that are also assessed remotely include longitudinal changes in MPVA minutes, physical fitness and prodromal symptoms of PD. Secondary endpoints that will be assessed via center visits include blood and brain MRI biomarkers.

Conclusion: This prototype exercise prevention trial will provide unique insights into the feasibility of remote trial administration for future prevention trials of PD. Slow-SPEED-NL is one of three planned studies examining the feasibility of a remote exercise intervention in at-risk groups, namely iRBD, hyposmia and LRRK2/GBA1 mutation carriers. We foresee results of these separate trials (The Netherlands, UK & USA) being synthesized in one meta-analysis. Our ambition is that this umbrella study will have adequate statistical power to examine the effectiveness of exercise on the progression of prodromal PD.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/slow-speed-nl-study-protocol-for-a-remote-trial-of-exercise-for-parkinsons-disease-prevention/