Effect of exercising at minimum recommendations of the multiple sclerosis exercise guideline combined with structured education or attention control education – secondary results of the step it up randomised controlled trial

Coote et al. BMC Neurology (2017) 17:119 DOI 10.1186/s12883-017-0898-y RESEARCH ARTICLE Open Access Effect of exercising at minimum recommendations of the multiple sclerosis exercise guideline combined with structured education or attention control education – secondary results of the step it up randomised controlled trial Susan Coote1,2* , Marcin Uszynski1,3, Matthew P. Herring2,4, Sara Hayes1,2, Carl Scarrott5,6, John Newell5,7, Stephen Gallagher2,8, Aidan Larkin3 and Robert W Motl9 Abstract Background: Recent exercise guidelines for people with multiple sclerosis (MS) recommend a minimum of 30 min moderate intensity aerobic exercise and resistance exercise twice per week. This trial compared the secondary outcomes of a combined 10-week guideline based intervention and a Social Cognitive Theory (SCT) education programme with the same exercise intervention involving an attention control education. Methods: Physically inactive people with MS, scoring 0–3 on Patient Determined Disease Steps Scale, with no MS relapse or change in MS medication, were randomised to 10-week exercise plus SCT education or exercise plus attention control education conditions. Outcomes included fatigue, depression, anxiety, strength, physical activity, SCT constructs and impact of MS and were measured by a blinded assessor pre and post-intervention and 3 and 6 month follow up. Results: One hundred and seventy-four expressed interest, 92 were eligible and 65 enrolled. Using linear mixed effects models, the differences between groups on all secondary measures post-intervention and at follow-up were not significant. Post-hoc, exploratory, within group analysis identified improvements in both groups post intervention in fatigue (mean Δ(95% CI) SCT -4.99(−9.87, −0.21), p = 0.04, Control −7.68(−12.13, −3.23), p = 0.00), strength (SCT -1.51(−2.41, −0.60), p < 0.01, Control −1.55(−2.30, −0.79), p < 0.01), physical activity (SCT 9.85(5.45, 14.23), p < 0.01, Control 12.92(4.69, 20.89), goal setting (SCT 7.30(4.19, 10.4), p < 0.01, Control 5.96(2.92, 9.01), p < 0.01) and exercise planning (SCT 5.88(3.37, 8.39), p < 0.01, Control 3.76(1.27, 6.25), p < 0.01) that were maintained above baseline at 3 and 6 month follow up (all p < 0.05). Only the SCT group improved at 3 and 6 month follow up in physical impact of MS(−4.45(−8.68, −0.22), −4.12(−8.25, 0.01), anxiety(−1.76(−3.20, −0.31), −1.99(−3.28, −0.71), depression(−1.51(−2.89, −0. 13), −1.02(−2.05, 0.01)) and cognition(5.04(2.51, 7.57), 3.05(0.81, 5.28), with a medium effect for cognition and fitness (Hedges’ g 0.75(0.24, 1.25), 0.51(0.01, 1.00) at 3 month follow up. (Continued on next page) * Correspondence: 1 Department of Clinical Therapies, University of Limerick, Limerick, Ireland 2 Health Research Institute, University of Limerick, Limerick, Ireland Full list of author information is available at the end of the article © The Author(s). 2017 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Coote et al. BMC Neurology (2017) 17:119 Page 2 of 14 (Continued from previous page) Conclusions: There were no statistically significant differences between groups for the secondary outcomes once age, gender, time since diagnosis and type of MS were accounted for. However, within the SCT group only there were improvements in anxiety, depression, cognition and physical impact of MS. Exercising at the minimum guideline amount has a positive effect on fatigue, strength and PA that is sustained at 3 and 6 months following the cessation of the program. Trial registration: ClinicalTrials.gov, NCT02301442, retrospectively registered on November 13th 2014. Keywords: Multiple sclerosis, Exercise, Fatigue, Cognition, Behaviour change techniques, Social cognitive theory, Randomised controlled trial Background Multiple sclerosis (MS) is a chronic and often progressive condition affecting the central nervous system. MS has many consequences, including impaired strength, fitness, mood, fatigue and cognition, along with limitations of activities such as walking that impact on quality of life. Available evidence supports the beneficial effects of exercise on fatigue [1, 2], depression [3] fitness [4], walking mobility [5, 6], in addition to quality of life [7]. Indeed, this evidence has led to the development of the MS Exercise guideline [8, 9] which recommends moderate intensity aerobic exercise for 30 min and resistance training involving major muscle groups twice weekly. We are not aware of a single trial that has actually documented the benefits of the exercise guidelines in MS. Of further concern, there are few studies in the MS exercise literature that have evaluated the long-term benefits of exercise interventions, and the results are mixed. For example, we reported positive improvements from a combined aerobic and resistance exercise programme in the community [10]; however, the improvements generally were not maintained 12 weeks post-intervention [11], suggesting that additional measures are required to enable sustained increases in physical activity behaviour among PwMS. This need to foster long-term exercise participation is not unique to PwMS and authors have highlighted the need to include theory-based behaviour change interventions [12]. Social cognitive theory has been extensively investigated among PwMS, and exercise self-efficacy and goal setting are consistently associated with [13] and predictive of [14] physical activity behaviour. Indeed a recent meta-analysis demonstrated significant associations of these constructs and outcome expectancies with physical activity [15]. We have conducted a series of clinical trials (i.e., Phase I and II) with relatively small samples for examining the efficacy of an Internet-delivered behavioural intervention based on social cognitive theory (SCT) for increasing physical activity among ambulatory persons with MS [16–19]. Our most recent trial included the website and one-one-one video coaching and demonstrated moderate to large improvements in minutes/day of moderate/vigorous physical activity, endurance walking performance, information processing speed, symptoms of fatigue, depression, anxiety, and pain, and quality of life (QOL) over a six-month period [20]. Collectively, such data support the efficacy of the behavioural intervention for increasing and sustaining physical activity in PwMS and possibly improving walking, cognition, symptoms, and QOL outcomes. The Step it Up study [21 (...truncated)