Table 3.
Main estimates of treatment effect
| Outcomes | 6 months | 12 months | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Usual care | Exercise programme | Adjusted estimate (95% CI); P value | Usual care | Exercise programme | Adjusted estimate (95% CI); P value | ||||||
| No | Mean (SD) | No | Mean (SD) | No | Mean (SD) | No | Mean (SD) | ||||
| ADAS-cog: cognitive subscale | 145 | 22.4 (9.4) | 298 | 22.9 (11.6) | −0.6 (−1.6 to 0.4); 0.24 | 137 | 23.8 (10.4) | 278 | 25.2 (12.3) | −1.4 (−2.6 to −0.2); 0.03 | |
| Sensitivity analyses: | |||||||||||
| Complete case analysis | 135 | 21.4 (8.5) | 280 | 21.7 (10.3) | −0.7 (−1.7 to 0.4); 0.20 | 119 | 22.4 (9.7) | 245 | 22.9 (10.6) | −1.7 (−3.0 to −0.4); 0.01 | |
| Worst score analysis | 145 | 23.8 (12.8) | 298 | 23.3 (12.5) | 0.4 (−0.8 to 1.7); 0.52 | 137 | 25.5 (13.7) | 278 | 26.6 (14.8) | −0.9 (−2.6 to 0.7); 0.27 | |
| ADAS-cog subscales: | |||||||||||
| Language* | 145 | 2 (1 to 5) | 299 | 2 (0 to 5) | 0.001 (−0.4 to 0.54); 1.00 | 137 | 2 (0.7 to 5) | 280 | 2 (1 to 7) | −0.2 (−0.86 to 0.45); 0.61 | |
| Memory | 145 | 17.3 (5.6) | 298 | 17.3 (6.9) | −0.5 (−1.2 to 0.3); 0.22 | 137 | 18.1 (5.6) | 279 | 18.5 (6.7) | −0.8 (−1.6 to 0.02); 0.06 | |
| Praxis* | 145 | 2 (1 to 3) | 299 | 1 (1 to 3) | −0.001 (−0.2 to 0.2); 1.00 | 137 | 1 (1 to 3) | 281 | 2 (1 to 3.9) | 0.1 (−0.4 to 0.2); 0.38 | |
| EQ-5D: | |||||||||||
| Score (self report) | 139 | 0.83 (0.21) | 292 | 0.80 (0.21) | 0.02 (−0.01 to 0.06); 0.24 | 131 | 0.82 (0.25) | 261 | 0.81 (0.22) | −0.002 (−0.04 to 0.04); 0.93 | |
| VAS score (self report) | 138 | 78.7 (18.8) | 288 | 75.4 (20.6) | −0.1 (−3.6 to 3.4); 0.94 | 124 | 78.3 (19.4) | 261 | 75.5 (19.3) | 1.4 (−2.4 to 5.2); 0.46 | |
| Score (proxy report) | 134 | 0.65 (0.29) | 277 | 0.64 (0.27) | −0.01 (−0.06 to 0.03); 0.53 | 128 | 0.60 (0.32) | 259 | 0.60 (0.28) | −0.02 (−0.07 to 0.03); 0.43 | |
| EQ-5D VAS (proxy report) | 135 | 65.4 (20.5) | 278 | 66.1 (20.1) | −0.6 (−4.3 to 3.1); 0.74 | 128 | 65.6 (19.9) | 260 | 65.0 (20.0) | 1.2 (−2.4 to 4.8); 0.52 | |
| EQ-5D score (carer report) | 132 | 0.77 (0.24) | 277 | 0.76 (0.23) | −0.004 (−0.04 to 0.03); 0.84 | 129 | 0.78 (0.23) | 261 | 0.76 (0.24) | −0.002 (−0.04 to 0.04); 0.94 | |
| EQ-5D VAS (carer report) | 136 | 72.4 (20.7) | 277 | 73.4 (19.7) | −1.4 (−4.7 to 1.8); 0.38 | 129 | 75.1 (18.7) | 261 | 74.5 (18.6) | 0.2 (−2.9 to 3.3); 0.90 | |
| ZBI (carer report) | 122 | 32.9 (17.1) | 273 | 33.9 (16.0) | 0.06 (−2.0 to 2.1); 0.96 | 125 | 32.7 (16.6) | 256 | 34.5 (16.1) | −0.5 (−2.8 to 1.7); 0.64 | |
| QoL-AD: | |||||||||||
| Score (self report) | 124 | 39.0 (5.9) | 263 | 38.9 (6.1) | −0.1 (−1.0 to 0.8); 0.88 | 119 | 39.1 (5.7) | 237 | 38.4 (5.8) | 0.7 (−0.2 to 1.7); 0.13 | |
| Score (proxy report) | 114 | 31.3 (6.2) | 239 | 31.6 (6.2) | 0.1 (−0.9 to 1.0); 0.89 | 118 | 30.6 (6.0) | 234 | 30.6 (6.1) | 0.02 (−1.0 to 1.0); 0.96 | |
| NPI (proxy report)* | 110 | 8.5 (3 to 22) | 234 | 12 (4 to 21) | −0.6 (−3.1 to 2.1); 056 | 105 | 9 (3 to 20) 13.5 (13.1) | 215 | 12 (4 to 23) | −2.1 (−4.8 to 0.7); 0.14 | |
| BADL (proxy report)* | 129 | 14.6 (10.4) | 271 | 14.6 (9.5) | 0.8 (−0.3 to 2.0); 0.15 | 124 | 15.9 (9.7) | 251 | 17.0 (10.2) | 0.3 (−1.7 to 1.2); 0.70 | |
ADAS-cog=Alzheimer’s disease assessment scale-cognitive subscale; EQ-5D=European quality of life measure; VAS=visual analogue scale; ZBI=Zarit burden interview; Qol-AD=quality of life Alzheimer’s disease scale; NPI=neuropsychiatric index; BADL=Bristol activity of daily living index.
Estimates are random effect models adjusted for age, sex, site, baseline mini mental state examination score and baseline value of the outcome variable being estimated.
*
Data are not normally distributed estimates and are obtained from median regression. Descriptive statistics are median and interquartile range.