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.

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 ∆(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. 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.

A randomised controlled trial of an exercise plus behaviour change intervention in people with multiple sclerosis: the step it up study protocol.

BACKGROUND: Exercise has consistently yielded short-term, positive effects on health outcomes in people with multiple sclerosis (MS). However, these effects have not been maintained in the long-term. Behaviour change interventions aim to promote long-term positive lifestyle change. This study, namely, "Step it Up" will compare the effect of an exercise plus Social Cognitive Theory (SCT)-based behaviour change intervention with an exercise plus control education intervention on walking mobility among people with MS. METHODS/DESIGN: People with a diagnosis of MS who walk independently, score of 0-3 on the Patient Determined Disease Steps, who have not experienced an MS relapse or change in their MS medication in the last 12 weeks and who are physically inactive will be randomised to one of two study conditions. The experimental group will undergo a 10-week exercise plus SCT-based behavioural change intervention. The control group will undergo a 10-week exercise plus education intervention to control for contact. Participants will be assessed at weeks 1, 12, 24 and 36. The primary outcome will be walking mobility. Secondary outcomes will include: aerobic capacity, lower extremity muscle strength, participant adherence to the exercise programme, self-report exercise intensity, self-report enjoyment of exercise, exercise self-efficacy, outcome expectations for exercise, goal-setting for exercise, perceived benefits and barriers to exercise, perceptions of social support, physical and psychological impact of MS and fatigue. A qualitative evaluation of Step it Up will be completed among participants post-intervention. DISCUSSION: This randomised controlled trial will examine the effectiveness of an exercise plus SCT-based behaviour change intervention on walking mobility among people with MS. To this end, Step it Up will serve to inform future directions of research and clinical practice with regard to sustainable exercise interventions for people with MS. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02301442.

Exercise in the community for people with multiple sclerosis--a follow-up of people with minimal gait impairment.

BACKGROUND: Although there are many studies evaluating exercise interventions, few studies have evaluated the effect at follow-up. OBJECTIVES: This paper presents follow-up data for participants who completed the exercise interventions in a large randomised controlled trial. METHODS: One hundred twenty-one people with multiple sclerosis (MS) with minimal gait impairment who completed 10 weeks of community-based exercise interventions were evaluated by a blinded assessor 12 weeks after the intervention. The primary outcome measure was the Multiple Sclerosis Impact Scale-29 version 2 (MSIS-29,v2) physical component. Other outcomes were the MSIS-29 psychological component, the Modified Fatigue Impact Scale (MFIS) and the 6-minute walk test (6MWT) distance. RESULTS: The positive effect on the physical impact of MS was not maintained from baseline to follow-up (-1.6, 95% CI -0.8, 4.0, p=0.189). The psychological impact and the impact of fatigue remained significantly improved (-3.5, 95% CI -6.1, -1.0, p = 0.006 and -4.68, 95% CI -6.9, -2.5, p < 0.001, respectively). There was no time effect for the 6MWT (f = 1.76, p = 0.179) although the trend suggests reversal of the benefits gained from the physiotherapist (PT)- and fitness instructor (FI)-led intervention. CONCLUSION: The maintained benefit on the psychological impact of MS and fatigue may have important personal and socioeconomic consequences; however, it is important to find ways to maintain the physical benefits of exercise over the long term.

An evaluation of the role of community care in meeting the needs of people with multiple sclerosis in Ireland.

BACKGROUND: People with MS (PwMS) can experience a number of diverse needs which may be met by community-based services such as those delivered by MS Ireland (MSI), where Community Workers (CWs) provide support to PwMS on an individualised basis. However, while such support may be critical in helping PwMS adapt and cope with the challenges of living with MS, there has been little evaluation of the outcomes and impacts of this service to date. This study aimed to explore the perceived effectiveness and impacts of community work from the perspectives of both PwMS and CWs. METHODS: Using stakeholder engagement and public and patient involvement (PPI), two surveys were developed for (1) CWs, and (2) services users of MSI. A series of open and closed questions centred on the effectiveness of community work in meeting twelve distinct categories of needs taken from an adapted framework of rehabilitation and healthcare needs of PwMS. Both CWs and service users rated the extent to which these various needs were met through community work, as well as describing the mechanisms by which needs were met, and the challenges faced in meeting these needs. Separately, both groups described the perceived impacts of community work using open-text responses. RESULTS: Fifteen CWs and 367 PwMS, 269 (73%) of whom knew their CW, participated. Both groups rated community work positively in meeting the needs for information, emotional/psychological support and coordination of care, with lower perceived capacity for community work to meet needs for employment accommodations, caregiver support and homecare. Mann Whitney U tests did not find any significant difference between groups in the perceived capacity of community work to meet the various needs examined (p>.05). Core mechanisms by which CWs meet needs are by signposting to relevant services, listening, and facilitating peer support. Difficulty accessing external services was the primary challenge identified in meeting needs. Positive impacts of community work included the role that CWs play in fostering confidence and acceptance of MS, and in helping service users overcome the challenges of MS. CONCLUSION: Results suggest how CWs can help meet the needs of PwMS, while also highlighting the numerous positive impacts that community work has for this group. While it is clear that a number of unmet needs may remain due to a lack of access to other external services, this study shows how community-based services may play an important role in helping PwMS adapt to living with MS.

Getting the balance right: a randomised controlled trial of physiotherapy and Exercise Interventions for ambulatory people with multiple sclerosis.

BACKGROUND: People with Multiple Sclerosis have a life long need for physiotherapy and exercise interventions due to the progressive nature of the disease and their greater risk of the complications of inactivity. The Multiple Sclerosis Society of Ireland run physiotherapy, yoga and exercise classes for their members, however there is little evidence to suggest which form of physical activity optimises outcome for people with the many and varied impairments associated with MS. METHODS AND DESIGN: This is a multi-centre, single blind, block randomised, controlled trial. Participants will be recruited via the ten regional offices of MS Ireland. Telephone screening will establish eligibility and stratification according to the mobility section of the Guys Neurological Disability Scale. Once a block of people of the same strand in the same geographical region have given consent, participants will be randomised. Strand A will concern individuals with MS who walk independently or use one stick to walk outside. Participants will be randomised to yoga, physiotherapy led exercise class, fitness instructor led exercise class or to a control group who don't change their exercise habits.Strand B will concern individuals with MS who walk with bilateral support or a rollator, they may use a wheelchair for longer distance outdoors. Participants will be randomised to 1:1 Physiotherapist led intervention, group intervention led by Physiotherapist, group yoga intervention or a control group who don't change their exercise habits. Participants will be assessed by physiotherapist who is blind to the group allocation at week 1, week 12 (following 10 weeks intervention or control), and at 12 week follow up. The primary outcome measure for both strands is the Multiple Sclerosis Impact Scale. Secondary outcomes are Modified Fatigue Impact Scale, 6 Minute Walk test, and muscle strength measured with hand held dynamometry. Strand B will also use Berg Balance Test and the Modified Ashworth Scale. Confounding variables such as sensation, coordination, proprioception, range of motion and other impairments will be recorded at initial assessment. DISCUSSION: Data analysis will analyse change in each group, and the differences between groups. Sub group analysis may be performed if sufficient numbers are recruited. TRIAL REGISTRATION: ISRCTN77610415.

Societal costs of multiple sclerosis in Ireland.

AIMS: This paper evaluates the impact of multiple sclerosis (MS) in Ireland, and estimates the associated direct, indirect, and intangible costs to society based on a large nationally representative sample. MATERIALS AND METHODS: A questionnaire was developed to capture the demographics, disease characteristics, healthcare use, informal care, employment, and wellbeing. Referencing international studies, standardized survey instruments were included (e.g. CSRI, MFIS-5, EQ-5D) or adapted (EDSS) for inclusion in an online survey platform. Recruitment was directed at people with MS via the MS Society mailing list and social media platforms, as well as in traditional media. The economic costing was primarily conducted using a 'bottom-up' methodology, and national estimates were achieved using 'prevalence-based' extrapolation. RESULTS: A total of 594 people completed the survey in full. The sample had geographic, disease, and demographic characteristics indicating good representativeness. At an individual level, average societal cost was estimated at €47,683; the average annual costs for those with mild, moderate, and severe MS were calculated as €34,942, €57,857, and €100,554, respectively. For a total Irish MS population of 9,000, the total societal costs of MS amounted to €429m. Direct costs accounted for just 30% of the total societal costs, indirect costs amounted to 50% of the total, and intangible or QoL costs represented 20%. The societal cost associated with a relapse in the sample is estimated as €2,438. LIMITATIONS AND CONCLUSIONS: The findings highlight that up to 70% of the total costs associated with MS are not routinely counted. These "hidden" costs are higher in Ireland than the rest of Europe, due in part to significantly lower levels of workforce participation, a higher likelihood of permanent workforce withdrawal, and higher levels of informal care needs. The relationship between disease progression and costs emphasize the societal importance of managing and slowing the progression of the illness.

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.

The Effect of Community Exercise Interventions for People with MS Who Use Bilateral Support for Gait.

Background. Mobility limitations are a key feature of MS and 25% will require the use of a walking aid 15 years after diagnosis. Few studies have specifically evaluated the effectiveness of physiotherapy and exercise interventions delivered in the community for those with significant disability. Methods. An assessor blind, block randomised, and controlled study recruited participants who required bilateral assistance for gait and who occasionally used wheelchairs for longer distances. They were randomised to 10 weeks of group physiotherapy (balance and strengthening exercises), individual physiotherapy, yoga group, or a control group. Results. Repeated measures ANOVA found significant time effects for physical component of MSIS-29v2 (f = 7.993, P = 0.006) and MFIS (f = 8.695, P = 0.004). The group × time interaction was significant for the BBS (f = 4.391, P = 0.006). Post hoc analysis revealed no difference between group and individual physiotherapy for BBS. There was no significant difference between groups but the 6MWT improved for individual physiotherapy (P = 0.001) and MSIS-29v2 psychological score for group physiotherapy (P = 0.005). Discussion. This study found that balance and strengthening exercises, delivered in the community to those with significant mobility limitations, improve balance. The effect on walking endurance and patient-reported outcomes are unclear and warrants further investigation with a larger control group with similar baseline characteristics to the intervention groups.