STEPWISE Parkinson: A Smartphone Based Exercise Solution for Patients With Parkinson's Disease

Mean change in step count per day as measured continuously with the participant's smartphone from baseline (week -4 to 0) to follow-up (week 49-52). Higher scores indicate more physical activity (steps).

Change from baseline in meters walked during the six minute walk test (6MWT) at week 53 (follow-up). Higher scores indicate better function.

Change from baseline in the Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) parts Ib and II at 53 weeks (follow-up). Range 0-80. Higher scores indicate worse function.

Change from baseline in VO2max in ml/kg/min assessed by a maximal aerobic exercise test on a cycle ergometer at follow-up (week 53). Higher scores indicate better function. Performed in a subgroup of 100 participants.

Change from baseline in the Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) at 53 weeks (follow-up). Range 0-199. Higher scores indicate worse function.

Total scores for Parts I, II, III, and IV will also be calculated.

Change from baseline in the sum of 5 MDS-UPDRS questions: walking and balance [question 2.12], freezing [q. 2.13], gait [q. 3.10], freezing of gait [q. 3.11], and postural stability [q. 3.12]). Higher scores imply worse symptoms.

Change from baseline in the time (seconds) needed to complete the Timed Up and Go Test (TUG) at 53 weeks (follow-up). Higher scores indicate worse function.

Change from baseline on the Mini-BestTest at 53 weeks (follow-up).Range 0-28. Higher scores indicate better function.

Change from baseline in gait speed (m/s) as assessed by the 10 meter walk test (10MWT). Higher scores indicate better function.

Change from baseline on the Dutch version of the Falls Efficacy Scale International at 53 weeks (follow-up). Range 16-64. Higher scores indicate higher fear of falling.

Number of falls and near-falls reported monthly by the participants in a fall diary drafted according to the European Physiotherapy guideline for Parkinson's Disease.

Change from baseline in hand grip strength (kg) as assessed with a dynamometer (best out of three attempts).

Change from baseline on the Longitudinal Aging Study Amsterdam (LASA) physical Activity Questionnaire (LAPAQ). Higher scores indicate a higher physical activity level.

Change from baseline on the Montreal Cognitive Assessement (MOCA) score at 53 weeks (follow-up). Range 0-30. Higher scores indicate better cognition.

Change from baseline on the Hospital Anxiety and Depression Scale (HADS) at 53 weeks (follow-up). Range 0-42. Higher scores indicate worse function.

Change from baseline on the Apathy Evaluation Scale (AES-12PD) at 53 weeks (follow-up). Range 12-48. Higher scores indicate better function.

Change from baseline on the Fatigue Severity Scale (FSS) at 53 weeks (follow-up). Range 1-7. Higher scores indicate worse function.

Change from baseline on the Scales for Outcomes in Parkinson's Disease - Sleep (SCOPA-Sleep) questionnaire at 53 weeks (follow-up).

Change from baseline on the Scales for Outcomes in Parkinson's Disease - autonomic questionnaire (SCOPA-AUT) at 53 weeks (follow-up).

Change from baseline on the Health related quality of life (PDQ-39) questionnaire at 53 weeks (follow-up). Range 0-100. Higher scores indicate better function.

Perceived effect of intervention as assessed by the Global Perceived effect (GPE) questionnaire (7-point scale) at 53 weeks (follow-up). Range 1-7. Higher scores indicate higher perceived effect.

Usability of the STEPWISE application as assessed by the Dutch version of the System Usability Scale (SUS) at 53 weeks (follow-up). Range 0-100. Higher scores indicate better usability.

Change from baseline on the percieved physical ability scale (Lichamelijke Vaardigheden Schaal; LIVAS) at 53 weeks (follow-up). Range 10-50. Higher scores indicate higher perceived phisical ability.

User data from the STEPWISE smartphone application will be collected, including number of interactions with the app and the total time the application was used.

Adherence to the study intervention as indicated by the number of days the STEPWISE app was used.

Barriers and motivators to engage in exercise/physical activity reported on the self-developed Barriers and Motivators questionnaire at week 0 (baseline) and week 53 (follow-up).

Movement data captured with a 6-axis inertial movement sensor (Axivity AX6).

Parkinson's disease symptoms monitored remotely with the mPower smartphone app.

Change in blood-based biomarkers. Assays will be determined before unblinding. Collected for a subgroup of participants (maximum n=135).