Baseline characteristics in the PDSAFE and control groups: figures are number (%) unless stated otherwise
| PDSAFE (n=238*) | Control (n=236†) | |
| Gender | ||
| Male Female | 147 (62%) 91 (38%) | 119 (50%) 117 (50%) |
| Age (years) | ||
| Mean (SD) Min to max | 71 (7.7) 51 to 91 | 73 (7.7) 46 to 88 |
| Disease duration (years) | ||
| Mean (SD) Min to max | 8 (6.6) 0 to 36 | 8 (5.8) 0 to 29 |
| MMSE | ||
| Mean (SD) Min to max | 28 (1.7) 24 to 30 | 29 (1.6) 24 to 30 |
| MoCA | ||
| Mean (SD) Min to max ≤25 (cognitively impaired) | 26 (2.9) 15 to 30 91 (38%) | 26 (3.2) 9 to 30 93 (39%) |
| Living status | ||
| Lived alone With a spouse/partner With a friend/family | 48 (20%) 174 (73%) 15 (6%) | 59 (25%) 166 (70%) 10 (4%) |
| Hoehn and Yahr stage | ||
| 1 2 3 4 | 26 (11%) 78 (33%) 102 (43%) 32 (13%) | 30 (13%) 56 (24%) 112 (48%) 38 (16%) |
| UPDRS | ||
| Mean (SD) Min to max TD phenotype PIGD phenotype Indeterminate phenotype | 32 (15.2) 2 to 77 21 (9%) 194 (83%) 20 (8%) | 33 (17.3) 4 to 92 19 (8%) 206 (88%) 10 (4%) |
| Freezing of gait in the past month | 152 (64%) | 139 (59%) |
| Number of falls in 12 months prior to screening | ||
| Median (min to max) Mean (SD) Repeat falling in 12 months | 3 (1 to 1460) 26 (132.7) 186 (78%) | 3 (1 to 1095) 19 (105.4) 189 (80%) |
| Rate of falls/person/3 months prior to randomisation | ||
| Median (min to max) Mean (SD) | 1.98 (0 to 319) 5.9 (22.8) | 0.99 (0 to 73) 3.0 (7.3) |
| Rate of near falls/person/3 months prior to randomisation | ||
| Median (min to max) Mean (SD) | 4.4 (0 to 440) 13.8 (35.8) | 4.3 (0 to 601) 15.6 (51.4) |
| Medications | ||
| Levodopa Dopamine agonist Monoamine oxidase inhibitor COMT inhibitors Other PD medication | 208 (88%) 108 (46%) 52 (22%) 59 (25%) 19 (8%) | 216 (92%) 106 (45%) 46 (20%) 41 (17%) 23 (10%) |
| GDS score at baseline | ||
| >5 (suggestive of depression) ≥10 (indicative of depression) | 147/235 (63%) 50/235 (21%) | 164/236 (70%) 49/236 (21%) |
| Coexisting conditions | ||
| Orthopaedic Cardio/respiratory | 109 (46%) 85 (36%) | 129 (54%) 96 (41%) |
*Missing values in the intervention group: living status (1); UPDRS (1); disease duration (1); freezing of gait (1); rate of falling in the 3 months prior to randomisation (1); TD/PIGD/Indeterminate phenotype (3).
†Missing values in the control group: living status (1); UPDRS (1); TD/PIGD/Indeterminate phenotype (1).
GDS, Geriatric Depression Scale; MMSE, Mini-Mental State Examination; MoCA, Montreal Cognitive Assessment; PD, Parkinson's disease; UPDRS, Unified Parkinson’s Disease Rating Scale.