Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Other |
STEPWISE Parkinson smartphone application data |
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. |
From baseline (week 0) to follow-up (week 53) |
|
| Other |
Adherence to the intervention |
Adherence to the study intervention as indicated by the number of days the STEPWISE app was used. |
From baseline (week 0) to follow-up (week 53) |
|
| Other |
Barriers and motivators to engage in exercise/physical activity at baseline and follow-up |
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). |
Week 0 (baseline) and week 53 (follow-up) |
|
| Other |
Exploratory measurement of physical acitivity with wearable sensor |
Movement data captured with a 6-axis inertial movement sensor (Axivity AX6). |
From week 0 (baseline) to week 1 and from week 52 to week 53 (follow-up) |
|
| Other |
Parkinson's disease symptoms monitored with the mPower app |
Parkinson's disease symptoms monitored remotely with the mPower smartphone app. |
Every three months from week 0 (baseline) to week 53 (follow-up) |
|
| Primary |
Mean change in step count per day |
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). |
Week -4 until 0 and week 49 until 52 |
|
| Secondary |
Change in physical fitness (6MWT) |
Change from baseline in meters walked during the six minute walk test (6MWT) at week 53 (follow-up). Higher scores indicate better function. |
Week 0 (baseline) and week 53 (follow-up) |
|
| Secondary |
Change in physical fitness (VO2max) |
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. |
Week 0 (baseline) and week 53 (follow-up) |
|
| Secondary |
Change in Parkinson's Disease symptoms (MDS-UPDRS) |
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. |
Week 0 (baseline) and week 53 (follow-up) |
|
| Secondary |
Change in mobility (TUG) |
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. |
Week 0 (baseline) and week 53 (follow-up) |
|
| Secondary |
Change in balance (Mini-BestTest) |
Change from baseline on the Mini-BestTest at 53 weeks (follow-up).Range 0-28. Higher scores indicate better function. |
Week 0 (baseline) and week 53 (follow-up) |
|
| Secondary |
Change in gait speed (10MWT) |
Change from baseline in gait speed (m/s) as assessed by the 10 meter walk test (10MWT). Higher scores indicate better function. |
Week 0 (baseline) and week 53 (follow-up) |
|
| Secondary |
Change in fear of falling (FES-I) |
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. |
Week 0 (baseline) and week 53 (follow-up) |
|
| Secondary |
Number of falls and near-falls (monthly fall diary) |
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. |
Every four weeks after start of the intervention (at 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 weeks). |
|
| Secondary |
Change in handgrip strength |
Change from baseline in hand grip strength (kg) as assessed with a dynamometer (best out of three attempts). |
Week 0 (baseline) and week 53 (follow-up) |
|
| Secondary |
Change in self-reported physical activity level (LAPAQ) |
Change from baseline on the Longitudinal Aging Study Amsterdam (LASA) physical Activity Questionnaire (LAPAQ). Higher scores indicate a higher physical activity level. |
Week -4 (screening), week 0 (baseline) and week 53 (follow-up) |
|
| Secondary |
Change in cognition (MOCA) |
Change from baseline on the Montreal Cognitive Assessement (MOCA) score at 53 weeks (follow-up). Range 0-30. Higher scores indicate better cognition. |
Week 0 (baseline) and week 53 (follow-up) |
|
| Secondary |
Change in depression and anxiety (HADS) |
Change from baseline on the Hospital Anxiety and Depression Scale (HADS) at 53 weeks (follow-up). Range 0-42. Higher scores indicate worse function. |
Week 0 (baseline) and week 53 (follow-up) |
|
| Secondary |
Change in apathy (AES-12PD) |
Change from baseline on the Apathy Evaluation Scale (AES-12PD) at 53 weeks (follow-up). Range 12-48. Higher scores indicate better function. |
Week 0 (baseline) and week 53 (follow-up) |
|
| Secondary |
Change in fatigue (FSS) |
Change from baseline on the Fatigue Severity Scale (FSS) at 53 weeks (follow-up). Range 1-7. Higher scores indicate worse function. |
Week 0 (baseline) and week 53 (follow-up) |
|
| Secondary |
Change in severity of sleep problems and daytime sleepiness (SCOPA-SLEEP) |
Change from baseline on the Scales for Outcomes in Parkinson's Disease - Sleep (SCOPA-Sleep) questionnaire at 53 weeks (follow-up). |
Week 0 (baseline) and week 53 (follow-up) |
|
| Secondary |
Change in autonomic dysfunction (SCOPA-AUT) |
Change from baseline on the Scales for Outcomes in Parkinson's Disease - autonomic questionnaire (SCOPA-AUT) at 53 weeks (follow-up). |
Week 0 (baseline) and week 53 (follow-up) |
|
| Secondary |
Change in Health related quality of life (PDQ-39) |
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. |
Week 0 (baseline) and week 53 (follow-up) |
|
| Secondary |
Perceived effect of intervention (GPE) |
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. |
At week 53 (follow-up) |
|
| Secondary |
System Usability (SUS) |
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. |
At week 53 (follow-up) |
|
| Secondary |
Perceived physical ability (LIVAS) |
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. |
Week 0 (baseline) and week 53 (follow-up) |
|
