A multimodal intervention for patients with secondary progressive multiple sclerosis: feasibility and effect on fatigue

Abstract

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.

Figures

FIG. 1.

Flow diagram of subject enrollment, eligibility, and follow-up during 12 months.

FIG. 2.

Average dietary adherence (% adherent days) of each subject and the group (Grp.) at 3, 6, 9, and 12 months. Subject 2 did not complete logs from months 9–12.

FIG. 3.

Average exercise–neuromuscular electrical stimulation (NMES) adherence (% adherent days) of each subject and the group at baseline, 3, 6, 9, and 12 months. Subject 2 did not complete logs from months 9–12.

FIG. 4.

Perceived fatigue (Fatigue Severity Scale score) of each subject and the group (Grp.) average at baseline, 3, 6, 9, and 12 months.