Table 2.
Study schedule and assessments
| t = wk 0 | t = wk 1-2 | t = wk 2-3 | t = wk 26-27 | t = wk 27-28 | |
|---|---|---|---|---|---|
| Activity/Assessment | Pre-study screening (phone) | Study visit 1 (Screening/Baseline) | @ home | Study visit 2 (post-intervention) | @ home |
| Inclusion/Exclusion criteria | |||||
| Cardiovascular risk factors | |||||
| Rose questionnaire | x | ||||
| Physical exam & ECG | x | x | |||
| MMSE | x | ||||
| LAPAQ outdoor | x | ||||
| H&Y stage | x | x | |||
| Primary outcome | |||||
| Motor symptoms | |||||
| MDS-UPDRS III off | x | x | |||
| Secondary outcomes | |||||
| Motor symptoms | |||||
| MDS-UPDRS III on | x | x | |||
| MDS-UPDRS IV | x | x | |||
| TUG | x | x | |||
| Pegboard | x | x | |||
| Finger tap test | x | x | |||
| Mini-BESTest | x | x | |||
| Falls & Near-falls | x | x | |||
| Non-motor symptoms | |||||
| TAP flexibility | x | x | |||
| TMT | x | x | |||
| MoCa | x | x | |||
| SCOPA-sleep | x | x | |||
| HADS | x | x | |||
| SCOPA-AUT | x | x | |||
| FSS | x | x | |||
| Quality of life | |||||
| PDQ-39 | x | x | |||
| Physical fitness | |||||
| VO2max | x | x | |||
| 6MWT | x | x | |||
| Adherence | |||||
| Bike computer/motivational app data | Data is automatically collected after each workout on a secured server. After 6 months the data is archived and locked. |
ECG = electrocardiogram. MMSE = Mini Mental State Examination, LAPAQ = Longitudinal aging study Amsterdam Physical Activity Questionnaire. H&Y = Hoehn & Yahr, MDS-UPDRS III/IV = Movement Disorders Society-sponsored revision of the Unified Parkinson’s Disease Rating Scale, motor section (III) and motor complications section (IV). TUG = Timed Up and Go test. Mini-BESTets = Mini-Balance Evaluation System Test. TAP = Test of Attentional Performance. TMT = Trial Making Test. MoCa = Montreal Cognitive Assessment. SCOPA-sleep = SCales for Outcomes in PArkinson’s disease, sleep section. SCOPA-aut = SCales for Outcomes in PArkinson’s disease, autonomic function section. FSS = Fatigue Severity Scale. PDQ-39 = 39-item Parkinson Disease Questionnaire VO2max = maximal amount of oxygen inhaled during maximal graded test. 6MWT = 6 Minute Walk Test.