Table 2.
SPARX3 trial outcomes
| Domain | Specific measurement variable | Metric | Method of aggregation | Timepoint(s) | |
|---|---|---|---|---|---|
| Primary outcome | |||||
| (1) MDS-UPDRS part 3 | Motor sign assessment of Parkinson’s disease | MDS-UPDRS part III | Score at time point assessed | Mean | 12 months |
| Secondary outcomes | |||||
| (1) DatScan (Dopaminergic activity) | Dopamine neuron function (Brain Imaging) | Striatal specific binding ratio | Value at time point assessed | Mean | 12 months |
| (2) Six min walk | Functional capacity | Distance walked in 6 min in meters | Value at time point assessed | Mean | 12 and 18 months |
| (3) MDS-UPDRS part 3 | Motor sign assessment of Parkinson’s disease | MDS-UPDRS part III | Score at time point assessed | Mean | 18 months |
| (4) Activity Level | Physical activity | Number of daily steps | Value at time point assessed | Mean | 12 and 18 months |
| (5) Cognitive Function | Cognitive function | Montreal Cognitive Assessment Scale | Score at time point assessed | Mean | 12 and 18 months |
| (6) Peak VO2 | Cardiorespiratory fitness | Peak volume of oxygen consumed | Value at time point assessed | Mean | 12 and 18 months |
| (7) The Parkinson Disease Questionnaire (PDQ-39) | Quality of life | PDQ-39 | Score at time point assessed | Mean | 12 and 18 months |
| (8) Initiation of dopaminergic therapy | Symptom progression | Time (months) | Month of drug initiation | Time to event | --- |
| (9) C-Reactive Protein | Inflammation | CRP protein (mg/L) | Value at time point assessed | Mean | 12 and 18 months |
| (10) Brain-derived neurotrophic factor | Neuronal function and survival | BDNF protein (ng/ml) | Value at time point assessed | Mean | 12 and 18 months |
| Tertiary outcomes | |||||
| (1) Stride Length | Gait | Length of stride (meters) | Value at time point assessed | Mean | 12 and 18 months |
| (2) Turning Velocity | Gait | Turning velocity (degrees/second) | Value at time point assessed | Mean | 12 and 18 months |