Comparing the effects of whole-body vibration to standard exercise in ambulatory people with Multiple Sclerosis: a randomised controlled feasibility study.

OBJECTIVES: This study aimed firstly to investigate the feasibility of the study protocol and outcome measures, secondly to obtain data in order to inform the power calculations for a larger randomised controlled trial, and finally to investigate if whole-body vibration (WBV) is more effective than the same duration and intensity of standard exercises (EXE) in people with Multiple Sclerosis (PwMS). DESIGN: Randomised controlled feasibility study. SETTING: Outpatient MS centre. SUBJECTS: Twenty seven PwMS (age mean (SD) 48.1 (11.2)) with minimal gait impairments. INTERVENTIONS: Twelve weeks of WBV or standard EXE, three times weekly. MAIN MEASURES: Participants were measured with isokinetic muscle strength, vibration threshold, Timed Up and Go test (TUG), Mini-BESTest (MBT), 6 Minute Walk test (6MWT), Multiple Sclerosis Impact Scale 29 (MSIS 29), Modified Fatigue Impact Scale (MFIS) and Verbal Analogue scale for sensation (VAS) pre and post 12 week intervention. RESULTS: WBV intervention was found feasible with low drop-out rate (11.1%) and high compliance (90%). Data suggest that a sample of 52 in each group would be sufficient to detect a moderate effect size, with 80% power and 5% significance for 6 minute walk test. Large effect sizes in favour of standard exercise were found for vibration threshold at 5th metatarsophalangeal joint and heel (P=0.014, r= 0.5 and P=0.005, r=0.56 respectively). No between group differences were found for muscle strength, balance or gait (P>0.05). CONCLUSIONS: Data suggest that the protocol is feasible, there were no adverse effects. A trial including 120 people would be needed to detect an effect on walking endurance.

Social Cognitive Theory Correlates of Physical Activity in Inactive Adults with Multiple Sclerosis.

BACKGROUND: There is a growing body of evidence that physical activity (PA) improves symptoms of multiple sclerosis (MS). Despite the benefits of PA, people with MS are relatively inactive compared with their healthy counterparts. This study investigated associations between social cognitive theory (SCT) constructs and energy expenditure (EE) as an objective measure of PA in a sample of inactive people with MS. METHODS: Participants (n = 65) completed several questionnaires and were assessed using standardized outcome measures as part of a cross-sectional analysis of baseline data from a randomized controlled trial (Step it Up). RESULTS: The bivariate correlation analysis indicated that of all SCT constructs, only exercise self-efficacy was significantly correlated with EE (r = 0.297, P = .022). Multiple linear regression analysis found that exercise self-efficacy independently explained 9% of the variance in EE (R2 = 0.088). A model including exercise self-efficacy, exercise goal setting, exercise planning, and exercise benefits explained 17% of the variance in EE (F4,54 = 2.741, P = .038, R2 = 0.169). In this model, only exercise self-efficacy was significantly associated with EE scores (Exercise Self-Efficacy Scale ß = .320, P = .016). CONCLUSIONS: The constructs of SCT explained little of the variance of objectively measured PA in a sample of inactive people with MS who volunteered for an exercise trial. The only significant variable was exercise self-efficacy, which confirms the importance of enhancing it through PA interventions.

Randomised controlled pilot trial of an exercise plus behaviour change intervention in people with multiple sclerosis: the Step it Up study.

OBJECTIVE: To investigate feasibility of multiple sclerosis (MS) exercise guidelines for inactive people with MS (PwMS) and to examine preliminary efficacy for walking. To investigate effect of augmenting that intervention with education based on social cognitive theory (SCT). DESIGN: Pilot multicentre, double-blind, randomised, parallel, controlled trial. SETTING: Community-delivered programme. PARTICIPANTS: Sixty-five physically inactive PwMS walked independently, scored 0-3 on the Patient Determined Disease Steps Scale, had no MS relapse or change in MS medication in 12 weeks. INTERVENTIONS: 10-week exercise plus SCT education (SCT) compared with exercise plus attention control education (CON). OUTCOME MEASURES: Six-Minute Walk Test (6MWT), Timed Up and Go (TUG) test and Multiple Sclerosis Walking Scale-12 (MSWS-12). RESULTS: 174 expressed interest, 92 were eligible and 65 enrolled (SCT, n=32; CON, n=33). The intervention was feasible and delivered as intended. 68% of SCT group and 50% of control group met the exercise guidelines after intervention. Using linear mixed effects models, intention-to-treat basis, there was insufficient evidence for difference between the groups over the trial (6MWT, p=0.30; TUG, p=0.4; MSWS-12, p=0.8). Using secondary analysis of a cohort with data for≥3 assessments (SCT, n=21; CON, n=20), there was significant treatment effect favouring the intervention group (p=0.04) with mean effect for 6MWT 39.0 m (95% CI 2.26 to 75.73) at 12 weeks and 40.0 m (95% CI 2.3 to 77.8) at 36 weeks. Both groups improved significantly in 6MWT following 10-week intervention (SCT, mean ∆=83.02, SD=60.1, p≤0.01; CON, mean ∆=56.92, SD=73.5, p≤0.01), TUG (SCT, ∆=-0.70, SD=1.25, p≤0.01; CON, ∆=-0.54, SD=0.95, p≤0.01) and MSWS-12 (SCT, ∆=-8.03, SD=16.18, p=0.02; CON, ∆=-0.86, SD=18.74, p=0.81). CONCLUSIONS: A 10-week exercise programme based on the MS exercise guidelines for improving walking in previously inactive PwMS was feasible. There is marginal evidence of a treatment effect in favour of the exercise plus SCT intervention at 12 and 36 weeks. TRIAL REGISTRATION NUMBER: NCT02301442; Results.