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Published on: January 29, 2016
RCT of a Telehealth Group-Based Intervention to Increase Physical Activity in Multiple Sclerosis: eFIT
Victoria M Leavitt1, Ines M Aguerre1, Nancy Lee1
1Translational Cognitive Neuroscience Laboratory (VML), Multiple Sclerosis Center (VML, IMA, CSR, PLDJ, SB), Center for Translational & Computational Neuroimmunology (IMA, CSR, PLDJ), Department of Neurology, Columbia University Irving Medical Center; and Department of Rehabilitation and Regenerative Medicine (NL), Columbia University Vagelos College of Physicians and Surgeons, New York.
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).
