BACKGROUND: Multiple sclerosis is an autoimmune disease influenced by environmental factors. OBJECTIVES: The feasibility of a multimodal intervention and its effect on perceived fatigue in patients with secondary progressive multiple sclerosis were assessed. DESIGN/ SETTING: This was a single-arm, open-label intervention study in an outpatient setting. INTERVENTIONS: A multimodal intervention including a modified paleolithic diet with supplements, stretching, strengthening exercises with electrical stimulation of trunk and lower limb muscles, meditation, and massage was used. OUTCOME MEASURES: Adherence to each component of the intervention was calculated using daily logs. Side-effects were assessed from a monthly questionnaire and blood analyses. Fatigue was assessed using the Fatigue Severity Scale (FSS). Data were collected at baseline and months 1, 2, 3, 6, 9, and 12. RESULTS: Ten (10) of 13 subjects who were enrolled in a 2-week run-in phase were eligible to continue in the 12-month main study. Of those 10 subjects, 8 completed the study and 6 subjects fully adhered to the study intervention for 12 months. Over a 12-month period, average adherence to diet exceeded 90% of days, and to exercise/muscle stimulation exceeded 75% of days. Nutritional supplements intake varied among and within subjects. Group daily average duration of meditation was 13.3 minutes and of massage was 7.2 minutes. No adverse side-effects were reported. Group average FSS scores decreased from 5.7 at baseline to 3.32 (p=0.0008) at 12 months. CONCLUSIONS: In this small, uncontrolled pilot study, there was a significant improvement in fatigue in those who completed the study. Given the small sample size and completer rate, further evaluation of this multimodal therapy is warranted.
RCT Entities:
BACKGROUND:Multiple sclerosis is an autoimmune disease influenced by environmental factors. OBJECTIVES: The feasibility of a multimodal intervention and its effect on perceived fatigue in patients with secondary progressive multiple sclerosis were assessed. DESIGN/ SETTING: This was a single-arm, open-label intervention study in an outpatient setting. INTERVENTIONS: A multimodal intervention including a modified paleolithic diet with supplements, stretching, strengthening exercises with electrical stimulation of trunk and lower limb muscles, meditation, and massage was used. OUTCOME MEASURES: Adherence to each component of the intervention was calculated using daily logs. Side-effects were assessed from a monthly questionnaire and blood analyses. Fatigue was assessed using the Fatigue Severity Scale (FSS). Data were collected at baseline and months 1, 2, 3, 6, 9, and 12. RESULTS: Ten (10) of 13 subjects who were enrolled in a 2-week run-in phase were eligible to continue in the 12-month main study. Of those 10 subjects, 8 completed the study and 6 subjects fully adhered to the study intervention for 12 months. Over a 12-month period, average adherence to diet exceeded 90% of days, and to exercise/muscle stimulation exceeded 75% of days. Nutritional supplements intake varied among and within subjects. Group daily average duration of meditation was 13.3 minutes and of massage was 7.2 minutes. No adverse side-effects were reported. Group average FSS scores decreased from 5.7 at baseline to 3.32 (p=0.0008) at 12 months. CONCLUSIONS: In this small, uncontrolled pilot study, there was a significant improvement in fatigue in those who completed the study. Given the small sample size and completer rate, further evaluation of this multimodal therapy is warranted.
Authors: G L Bowman; L C Silbert; D Howieson; H H Dodge; M G Traber; B Frei; J A Kaye; J Shannon; J F Quinn Journal: Neurology Date: 2011-12-28 Impact factor: 9.910
Authors: O Andersen; I Elovaara; M Färkkilä; H J Hansen; S I Mellgren; K-M Myhr; M Sandberg-Wollheim; P Soelberg Sørensen Journal: J Neurol Neurosurg Psychiatry Date: 2004-05 Impact factor: 10.154
Authors: Richard A Rudick; William H Stuart; Peter A Calabresi; Christian Confavreux; Steven L Galetta; Ernst-Wilhelm Radue; Fred D Lublin; Bianca Weinstock-Guttman; Daniel R Wynn; Frances Lynn; Michael A Panzara; Alfred W Sandrock Journal: N Engl J Med Date: 2006-03-02 Impact factor: 91.245
Authors: Loredana La Mantia; Laura Vacchi; Marco Rovaris; Carlo Di Pietrantonj; George Ebers; Sten Fredrikson; Graziella Filippini Journal: J Neurol Neurosurg Psychiatry Date: 2012-09-05 Impact factor: 10.154