Results for outcome measures at baseline, week 3 and week 6 of the intervention*
| Control | Intervention | |||||||
| Baseline (n=21) | 3 weeks | 6 weeks | Baseline (n=20) | 3 weeks | 6 weeks | Relative risk† | Effect sizes with 95% CI‡ | |
| Fatigue | ||||||||
| Neuro-QoL | 25.86±1.27 | 22.55±1.18 | 22.95±1.51 | 27.63±0.88 | 24.21±1.21 | 22.95±1.17 | 1.45 | 0.04 (−0.40 to 0.48) |
| Fatigability | ||||||||
| AMIPB | ||||||||
| Incorrect | 1±2 | 1±1 | 1±2 | 0±1 | 0±1 | 0±1 | −0.13 (−0.34 to 0.09) | |
| Time | 53.83±3.83 | 55.80±5.00 | 52.43±3.44 | 58.85±4.01 | 57.66±4.07 | 58.67±4.74 | 0.11 (−0.34 to 0.55) | |
| 6 min walk | 344±17.67 | n/a | 354.5±19.29 | 360.9±13.15 | n/a | 394.6±18.11 | 1.80 | 0.45 (0.18 to 1.07) |
| Numerical rating scale fatigue | n/a | 35+12 | 34+16 | n/a | 33+18 | 31+18 | ||
| Quality of life | ||||||||
| EQ5D-5L | ||||||||
| Mobility | 2±3 | 2±3 | 1.5±3 | 1±2 | 1±2 | 1±2 | −0.02 (−0.26 to 0.22) | |
| Self-care | 1±2 | 1±2 | 1±2 | 1±1 | 1±1 | 1±1 | −0.30 (−0.43 to 0.16) | |
| Usual activities | 2±3 | 2±2 | 2±3 | 2±2 | 2±2 | 2±2 | −0.12 (−0.33 to 0.11) | |
| Pain/ discomfort | 2±3 | 2±3 | 2±3 | 2±3 | 2±2 | 2±3 | −0.25 (−0.45 to 0.02) | |
| Anxiety/depression | 1±2 | 1±2 | 1±2 | 2±2 | 2±2 | 2±2 | 0.15 (−0.07 to 0.36) | |
| Health today VAS | 67.71±3.30 | 68.50±3.98 | 74.15±3.56 | 71.58±3.48 | 71.95±3.25 | 72.79±3.30 | 0.24 (−0.21 to 0.69) | |
| HADS | ||||||||
| Depression | 5±8 | 4±7 | 4.5±9 | 4±5 | 5±7 | 5±7 | 0.09 (−0.15 to 0.33) | |
| Anxiety | 7.62±0.74 | 7.25±0.70 | 6.65±0.80 | 7.32±0.83 | 7.21±0.83 | 6.63±0.82 | 0.14 (−0.31 to 0.58) | |
| PBMSI | ||||||||
| Walking | 2±2 | 2±2 | 1.5±2 | 1±2 | 1±2 | 1.5±2 | −0.15 (−0.35 to 0.07) | |
| Fatigue | 2±2 | 2±2 | 2±2 | 2±2 | 2±2 | 2±2 | −0.12 (−0.29 to 0.06) | |
| Mood | 1±2 | 1±2 | 1±2 | 1±2 | 1±2 | 1±2 | −0.10 (−0.30 to 0.11) | |
| Concentration | 2±3 | 2±2 | 2±2 | 2±2 | 2±2 | 2±2 | 0.05 (−0.15 to 0.26) | |
| Roles/responsibility | 1±2 | 1±2 | 1±2 | 1±2 | 1±1 | 1±2 | −0.06 (−0.25 to 0.14) | |
| Mechanism | ||||||||
| Plasma | ||||||||
| Lipid peroxidation | 0.66±0.01 | 0.68±0.01 | 0.67±0.01 | 0.69±0.01 | 0.69±0.01 | 0.70±0.02 | 0.50 (0 to 0.99) | |
| TNFα | 0.12±0.01 | 0.12±0.01 | 0.10±0.01 | 0.13±0.01 | 0.11±0.01 | 0.11±0.01 | 0.01 (−0.22 to 0.23) | |
| Glutathione | 0.0043±0.0047 | 0.0045±0.0031 | 0.0035±0.0030 | 0.0034±0.0051 | 0.0035±0.0041 | 0.0060±0.0040 | 0.07 (−0.55 to 0.69) | |
*Values are means±SE for normally distributed values and medians±ranges (first to third quartile) for categorical data.
†Relative risks were calculated for measure of fatigue and fatigability for responders versus non-responders.
‡Effect sizes and confidence intervals are Cohen’s d, based on non-central t distributions of least squares means differences for continuous variables, using SAS 9.4 and Cliff’s delta, for categorical variables, using R 3.5.
AMIPB, Adult Memory and Information Processing Battery; HADS, Hospital Anxiety and Depression Scale; PBMSI, Preference-Based Multiple Sclerosis Index; QoL, qualify of life; TNF, tumour necrosis factor; VAS, Visual Analogue Scale.