RCT of a Telehealth Group-Based Intervention to Increase Physical Activity in Multiple Sclerosis
eFIT
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Abstract
Objective To conduct a pilot randomized controlled trial to determine whether participation in a group-based structured telehealth intervention increases physical activity in people with multiple sclerosis (MS).
Methods In this parallel-arms trial, all study procedures were administered remotely. Adults diagnosed with MS (any subtype) were randomized to one of two 12-week (1 h/wk) active conditions: eFIT, online moderated structured groups; or eJournal, online independent journaling. For comparison, a treatment-as-usual (TAU; i.e., no eFIT/eJournal) group was enrolled. The primary outcome was feasibility (completion and adherence). The secondary efficacy outcomes included self-reported physical activity level (International Physical Activity Questionnaire, IPAQ).
Results Participants were 37 adults with MS. The sample was diverse: 66.7% female; age range 23–64 years; 17.5% Hispanic, 12.5% Black; and progressive and relapsing-remitting disease subtypes. Regarding feasibility, 70.7% completed; average adherence was 74.9%. Physical activity in active groups increased by 34.2% (baseline IPAQ = 2,406.8 ± 1,959.7, follow-up = 3,229.4 ± 2,575.2) and decreased in the TAU group by 17.4% (baseline = 2,519.9 ± 1,500.1, follow-up = 2,081.2 ± 1,814.9); group × time interaction was not statistically significant [F(2,25) = 1.467, p = 0.250; partial η2 = 0.105].
Conclusions Telehealth represents an accessible, acceptable vehicle to deliver targeted behavioral treatments to a neurologic population. eFIT may be an effective intervention for increasing physical activity, a historically intractable treatment target, in individuals with MS. In addition, these results provide evidence for feasibility of conducting fully remote clinical trial research.
Classification of Evidence This study provides Class II evidence that for people with MS, participation in a group-based structured telehealth intervention compared with TAU resulted in a (non-significant) increase in self-reported physical activity level. The percentage of participants who completed follow-up questionnaires did not differ between groups. The trial was registered at ClinicalTrials.gov (NCT03829267).
Footnotes
Funding information and disclosures are provided at the end of the article. Full disclosure form information provided by the authors is available with the full text of this article at Neurology.org/cp.
Class of Evidence: NPub.org/coe
Infographic: http://links.lww.com/CPJ/A312
- Received July 2, 2020.
- Accepted December 7, 2020.
- © 2021 American Academy of Neurology
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