Table 2.
Outcome measures | n | Adjusted means |
Baseline–adjusted mean changes |
Mean differences between groups at 6-month follow-up |
|||
---|---|---|---|---|---|---|---|
Baseline |
Discharge |
2 months |
6 months |
ITT analysis |
|||
Mean (95% CI) | Mean (95% CI) | Mean (95% CI) | Mean (95% CI) | Mean (95% CI) | p value | ||
FAMSa (Score 0–176) | |||||||
Intervention | 209 | 115.9 (111.0, 120.8) | 12.6 (10.0, 15.2) | 3.0 (0.5, 5.3) | 0.6 (–2.1, 3.5) | 1.6 (–1.4, 4.7) | 0.232 |
Control | 204 | 115.1 (110.0, 120.4) | –1.0 (–3.5, 1.6) | Ref. | |||
MSIS-29 Physicala (Score 0–1001) | |||||||
Intervention | 209 | 40.8 (37.0, 44.6) | –12.0 (–14.1, –10.2) | –0.2 (–3.0, 2.3) | –0.6 (–3.0, 1.8) | 0.640 | |
Control | 204 | 41.0 (37.1, 45.1) | 0.4 (–2.1, 2.8) | Ref. | |||
MSIS-29 Psychologicala (Score 0–100b) | |||||||
Intervention | 209 | 31.8 (27.9, 35.2) | –9.7 (–11.6, –7.9) | –1.2 (–3.8, 1.2) | –2.7 (–5.6, –0.1) | 0.046 | |
Control | 204 | 29.8 (25.7, 33.3) | 1.5 (–0.7, 3.6) | Ref. | |||
15D Index (Score 0.106–1.000) | |||||||
Intervention | 209 | 0.771 (0.754, 0.789) | 0.011 (–0.007, 0.027) | 0.017 (0.005, 0.030) | 0.008 | ||
Control | 204 | 0.777 (0.762, 0.794) | –0.006 (–0.023, 0.008) | Ref. | |||
EQ-5D-5L Index (Score −0.624 to −1.000) | |||||||
Intervention | 209 | 0.638 (0.606, 0.669) | –0.032 (–0.070, 0.001) | 0.006 (–0.015, 0.028) | 0.596 | ||
Control | 204 | 0.638 (0.605, 0.669) | –0.038 (–0.075, –0.002) | Ref. | |||
EQ-VAS (Score 0–100) | |||||||
Intervention | 173 | 60.4 (56.7, 64.1) | 9.7 (7.1, 12.4) | 3.8 (–0.1, 7.1) | 2.5 (–1.1, 5.9) | 0.112 | |
Control | 165 | 62.9 (58.9, 66.6) | 1.2 (–2.5, 4.8) | Ref. | |||
Factor 1 | |||||||
Intervention | 209 | 0.064 (–0.147, 0.264) | 0.063 (–0.044, 0.187) | 0.116 (0.003, 0.229) | 0.039 | ||
Control | 204 | 0.130 (–0.068, 0.339) | –0.053 (–0.145, 0.059) | Ref. | |||
Factor 2 | |||||||
Intervention | 209 | –0.161 (–0.308, –0.010) | –0.053 (–0.186, 0.063) | 0.035 (–0.058, 0.139) | 0.473 | ||
Control | 204 | –0.189 (–0.342, –0.037) | –0.089 (–0.206, 0.030) | Ref. |
CI: confidence interval; FAMS: Functional Assessment in Multiple Sclerosis; ITT: Intention-To-Treat; MSIS-29: Multiple Sclerosis Impact Scale-29; EQ-VAS: EuroQol–visual analogue scales; EQ-5D-5L: EuroQoL 5 Dimensions 5 Levels.
Primary outcome.
Higher score indicates greater impact.