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Randomized controlled trial of a behavioral intervention targeting symptoms and physical activity in multiple sclerosis
Pilutti LA, Dlugonski D, Sandroff BM, Klaren R, Motl RW
Multiple Sclerosis Journal 2014 Apr;20(5):594-601
clinical trial
5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: Exercise training is beneficial, but most persons with multiple sclerosis (MS) are sedentary and physically inactive. This has prompted a new focus on the promotion of lifestyle physical activity in MS. We previously designed, tested, and refined a behavioral intervention delivered through the Internet that successfully increased lifestyle physical activity in MS, but have not evaluated the effects on secondary symptomatic and health-related quality of life (HRQOL) outcomes. OBJECTIVE: We conducted a 6-month randomized controlled trial (RCT) that examined the efficacy of an Internet-delivered, behavioral intervention for improving outcomes of fatigue, depression, anxiety, pain, sleep quality, and HRQOL in 82 ambulatory persons with MS. The secondary aim was to replicate previous results regarding change in free-living physical activity. RESULTS: There was a significant and positive effect of the intervention on fatigue severity (p = 0.001, partial-eta2 = 0.15) and its physical impact (p = 0.008, partial-eta2 = 0.09), depression (p = 0.006, partial-eta2 = 0.10), and anxiety (p = 0.006, partial-eta2 = 0.10). There were non-significant improvements in pain (p = 0.08, partial-eta2 = 0.04), sleep quality (p = 0.06, partial-eta2 = 0.05), and physical HRQOL (p = 0.06, partial-eta2 = 0.05). We replicated our previous results by demonstrating an increase in self-reported physical activity (p = 0.001, partial-eta2 = 0.13). CONCLUSIONS: Our results support behavioral interventions targeting lifestyle physical activity as an alternative approach for managing symptoms in MS.

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