Primary outcome measures | Baseline (n = 159) | Follow-up 1 (n = 146) | Follow-up 2 (n = 144) | Follow-up 3 (n = 131) |
---|---|---|---|---|
Global fatigue severity (GFS) subscale of the FAI (potential range 1 to 7, high scores indicate more fatigue) | ||||
FACETS mean (SD) | 5.60 (0.98) | 5.48 (0.92) | 5.26 (1.03) | 5.32 (1.00) |
CLP mean (SD) | 5.61 (1.09) | 5.55 (1.17) | 5.66 (0.93) | 5.70 (1.01) |
Mean difference in change from baseline [95% CI] | - | −0.03 (−0.33 to 0.28) | −0.36 (−0.63 to −0.08) | −0.30 (−0.61 to 0.01) |
p value | - | 0.86 | 0.01 | 0.06 |
Std effect size | - | −0.03 | −0.35 | −0.29 |
Multiple Sclerosis Impact Scale-29 (MSIS-29) (potential range 0 to 100, high scores indicate more impact) | ||||
FACETS mean (SD) | 49.6 (19.1) | 47.3 (18.2) | 44.9 (19.2) | 46.2 (19.1) |
CLP mean (SD) | 43.9 (17.6) | 42.2 (18.4) | 43.0 (17.3) | 47.2 (17.4) |
Mean difference in change from baseline [95% CI] | - | 1.44 (−2.36 to 5.24) | −1.56 (−6.45 to 3.34) | −4.34 (−8.61 to −0.08) |
p value | - | 0.46 | 0.53 | 0.046 |
Std effect size | - | 0.08 | −0.08 | −0.24 |
MS Fatigue Self-Efficacy scale (MS-FSE) (potential range 10 to 100, high scores indicate more certainty in controlling fatigue | ||||
FACETS mean (SD) | 45 (17) | 57 (17) | 56 (19) | 56 (16) |
CLP mean (SD) | 49 (16) | 50 (17) | 53 (17) | 52 (17) |
Mean difference in change from baseline [95% CI] | - | 9 (4 to 14) | 6 (0 to 12) | 6 (−1 to 12) |
p value | - | 0.001 | 0.048 | 0.09 |
Std effect size | - | 0.54 | 0.36 | 0.34 |
Statistically significant secondary outcome measures | ||||
Vitality subscale of the SF-36 (potential range 0 to 100, high scores indicate higher quality of life) | ||||
FACETS mean (SD) | 32.0 (16.8) | 35.6 (19.4) | 37.4 (20.3) | 37.70 (18.75) |
CLP mean (SD) | 35.1 (19.7) | 33.4 (16.8) | 34.4 (17.30 | 32.43 (17.69) |
Mean difference in change from baseline [95% CI] | - | 4.42 (−1.22 to 10.06) | 6.38 (0.45 to 12.32) | 6.64 (0.84 to 12.44) |
p value | - | 0.12 | 0.04 | 0.03 |
Std effect size | - | 0.24 | 0.35 | 0.37 |
Multiple Sclerosis Impact Scale-29 (MSIS-29) - Physical subscale (potential range 0 to100, high scores indicate more impact) | ||||
FACETS mean (SD) | 51.4 (21.4) | 48.8 (19.7) | 47.0 (21.3) | 47.4 (21.0) |
CLP mean (SD) | 46.6 (20.3) | 44.9 (20.5) | 46.5 (19.8) | 50.5 (20.1) |
Mean difference in change from baseline [95% CI] | - | 1.39 (−2.87 to 5.65) | −0.81 (−5.91 to 4.28) | −4.74 (−9.40 to −0.08) |
p value | - | 0.52 | 0.75 | 0.046 |
Std effect size | - | 0.07 | −0.04 | −0.23 |