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Randomized controlled trial of a telephone-delivered physical activity and fatigue self-management interventions in adults with multiple sclerosis
Plow M, Finlayson M, Liu J, Motl RW, Bethoux F, Sattar A
Archives of Physical Medicine and Rehabilitation 2019 Nov;100(11):2006-2014
clinical trial
6/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: No; Adequate follow-up: No; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

OBJECTIVE: To compare the effectiveness of telephone-delivered interventions on fatigue, physical activity, and quality of life outcomes in adults with multiple sclerosis (MS). DESIGN: A single-blinded, randomized controlled trial. Participants were randomized to contact-control intervention (CC), physical activity-only intervention (PA-only), and physical activity plus fatigue self-management intervention (FM+). Outcomes were measured at baseline (two weeks prerandomization), posttest (14 weeks postrandomization), and follow-up (26 weeks postrandomization). SETTING: Telephone-delivered in Midwest and Northeast regions of the United States. PARTICIPANTS: Inactive adults with MS (n = 208) and moderate-to-severe fatigue. INTERVENTIONS: Three or six group teleconferences followed by four individually tailored phone calls delivered over 12-weeks. An occupational therapist and research assistant delivered the teleconferences and phone calls, respectively. MAIN OUTCOME MEASURES: Primary outcomes were self-report fatigue and physical activity measured with Fatigue Impact Scale and Godin Leisure-Time Exercise Questionnaire, respectively. Secondary outcomes included quality of life measured with Multiple Sclerosis Impact Scale and moderate-to-vigorous exercise and step count measured with accelerometer. RESULTS: Linear mixed effects models showed FM+ significantly improved self-report fatigue (beta -11.08; p = 0.03) and physical activity (beta 0.54; p = 0.01) compared to CC at posttest. However, FM+ had non-significant differences compared to PA-only on self-report fatigue (beta -1.08, p = 0.84) and physical activity (beta 0.09; p = 0.68) at posttest. PA-only had significant improvements compared to CC on moderate-to-vigorous exercise (beta 0.38; p = 0.02) at posttest and step count at posttest (beta 1.30; p < 0.01) and follow-up (beta 1.31; p = 0.01). FM+ and PA-only had non-significant differences compared to CC on quality of life. CONCLUSIONS: Group teleconferences followed by tailored phone calls has a small yet statistically significant effect in promoting physical activity and reducing fatigue impact in people with MS.

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