Important considerations for feasibility studies in physical activity research involving persons with multiple sclerosis: A scoping systematic review and case study

Background Much research has been undertaken to establish the important benefits of physical activity in persons with multiple sclerosis (MS). There is disagreement regarding the strength of this research, perhaps because the majority of studies on physical activity and its benefits have not undergone initial and systematic feasibility testing. We aim to address the feasibility processes that have been examined within the context of physical activity interventions in MS. Method A systematic scoping review was conducted based on a literature search of five databases to identify feasibility processes described in preliminary studies of physical activity in MS. We read and extracted methodology from each study based on the following feasibility metrics: process (e.g. recruitment), resource (e.g. monetary costs), management (e.g. personnel time requirements) and scientific outcomes (e.g. clinical/participant reported outcome measures). We illustrate the use of the four feasibility metrics within a randomised controlled trial of a home-based exercise intervention in persons with MS. Results Twenty-five studies were identified. Resource feasibility (e.g. time and resources) and scientific outcomes feasibility (e.g. clinical outcomes) methodologies were applied and described in many studies; however, these metrics have not been systematically addressed. Metrics related to process feasibility (e.g. recruitment) and management feasibility (e.g. human and data management) are not well described within the literature. Our case study successfully enabled us to address the four feasibility metrics, and we provide new information on management feasibility (i.e. estimate data completeness and estimate data entry) and scientific outcomes feasibility (i.e. determining data collection materials appropriateness). Conclusion Our review highlights the existing research and provides a case study which assesses important metrics of study feasibility. This review serves as a clarion call for feasibility trials that will substantially strengthen the foundation of research on exercise in MS

Motivations towards exercise participation: Active persons with multiple sclerosis have greater self-directed and self-capable motivations

Objective To investigate differences in motivation perceptions towards exercise per Self Determination Theory and Theory of Planned Behaviour between active and insufficiently active persons with multiple sclerosis, given the well-being enhancements associated with exercise engagement for this population. Design Cross-sectional between-groups design where active persons ≥ 14 points on the Godin Leisure Time Exercise Questionnaire, and insufficiently active < 14. Setting Community setting in Australia. Participants Seventy Australian participants (Mean age = 49.61 years (SD= 12.79), FIM 64:6 , Patient Disability Disease Steps Median = 3). Interventions Not applicable. Main Outcome Measures Godin Leisure Time Exercise Questionnaire, and adaptations of Self Determination Theory (autonomous and controlling forms of motivation) and Theory of Planned Behaviour (attitudes to exercise, subjective norms to exercise, behavioural control to exercise, and intention to exercise) items tailored towards exercise perceptions. Results Active persons perceived higher ratings in comparison to insufficiently active persons of autonomous motivations towards their exercise d = 0.85, in addition to positive attitudes towards the value of exercised = 1.28, their behavioural control over exercise d = 1.86, and their enhanced intentions to engage in exercise d = 1.14. All effect sizes were large (d > 0.80). Conclusions These findings suggest the value of considering ways of enhancing the perceived autonomy towards engaging in physical activity, in addition to the reduction of barriers towards participating and enhancing positive attitudes towards the value of physical activity, when practitioners are working with persons living with MS

The effects of a 12-week leisure centre-based, group exercise intervention for people moderately affected with multiple sclerosis: a randomized controlled pilot study

&lt;b&gt;Objective:&lt;/b&gt; To establish the effects of a 12-week, community-based group exercise intervention for people moderately affected with multiple sclerosis. &lt;b&gt;Design:&lt;/b&gt; Randomised controlled pilot trial. &lt;b&gt;Setting:&lt;/b&gt; Two community leisure centres. &lt;b&gt;Participants:&lt;/b&gt; Thirty-two participants with multiple sclerosis randomised into intervention or control groups. &lt;b&gt;Intervention:&lt;/b&gt; The intervention group received 12 weeks of twice weekly, 60-minute group exercise sessions, including mobility, balance and resistance exercises. The control group received usual care. &lt;b&gt;Main outcome measures:&lt;/b&gt; An assessor blinded to group allocation assessed participants at baseline, after eight weeks and after 12 weeks. The primary outcome measure was 25-foot (7.6 m) walk time, secondary outcomes assessed walking endurance, balance, physical function, leg strength, body mass index, activity levels, fatigue, anxiety and depression, quality of life and goal attainment. &lt;b&gt;Results:&lt;/b&gt; The intervention made no statistically significant difference to the results of participants’ 25-foot walk time. However the intervention led to many improvements. In the intervention group levels of physical activity improved statistically between baseline and week 8 (P &#60; 0.001) and baseline and week 12 (P = 0.005). Balance confidence results showed a significant difference between baseline and week 12 (P = 0.013). Good effect sizes were found for dynamic balance (d = 0.80), leg strength (d = 1.33), activity levels (d = 1.05) and perceived balance (d = 0.94). &lt;b&gt;Conclusion:&lt;/b&gt; The results of the study suggest that community-based group exercise classes are a feasible option for people moderately affected with multiple sclerosis, and offer benefits such as improved physical activity levels, balance and leg strength

Changing Behaviour towards Aerobic and Strength Exercise (BASE): Design of a randomised, phase I study determining the safety, feasibility and consumer-evaluation of a remotely-delivered exercise programme in persons with multiple sclerosis

Background Multiple sclerosis is a chronic progressive neurological disease. Evidence attests to the benefits of exercise, guidelines for exercise in multiple sclerosis are available. Remote-delivery of exercise adherence programmes based on the exercise guidelines require urgent testing. Aims The design, and outcomes of Behaviour towards Aerobic and Strength Exercise in MS (BASE-MS), a remotely-delivered exercise training study based principles of behaviour change, will further evaluate the remote-delivery of the current exercise guidelines. Methods BASE is a 4-month clinically relevant randomised controlled trial to explore the delivery of a remotely supervised, guidelines-based exercise programme for persons with multiple sclerosis, underpinned by principles of health behaviour change. Initially, 72 persons with mild to moderate multiple sclerosis will be randomised in a 1:1:1 allocation to receive the BASE programme, or act as controls continuing usual care. On programme completion, exercise participants will be further randomised to an optimised adherence treatment or usual adherence. Our online survey assesses the primary outcome of exercise participation, and secondary outcomes of symptoms, and correlates of behaviour change at baseline, month four, month five and month eleven. Online surveys will capture coach and participant feedback to identify the contexts, mechanisms and outcomes of BASE implementation. Conclusions The research and clinical landscape for MS management must remain in-step with public health and health communication. BASE tests the remote-delivery of the current exercise guidelines for exercise in persons with MS. Safety, feasibility and evaluative outcomes will provide rich data for future remote-delivery of exercise in neurological conditions

Identifying preferred format and source of exercise information in persons with multiple sclerosis that can be delivered by health-care providers

Background: There is increasing recognition of the benefits of exercise in individuals with multiple sclerosis (MS), yet the MS population does not engage in sufficient amounts of exercise to accrue health benefits. There has been little qualitative inquiry to establish the preferred format and source for receiving exercise information from health-care providers among persons with MS. Objective: We sought to identify the desired and preferred format and source of exercise information for persons with MS that can be delivered through health-care providers. Setting and participants: Participants were adults with MS who had mild or moderate disability and participated in a range of exercise levels. All participants lived in the Midwest of the United States. Methods: Fifty semi-structured interviews were conducted and analysed using thematic analysis. Results: Two themes emerged, (i) approach for receiving exercise promotion and (ii) ideal person for promoting exercise. Persons with MS want to receive exercise information through in-person consultations with health-care providers, print media and electronic media. Persons with MS want to receive exercise promotion from health-care providers with expertise in MS (ie neurologists) and with expertise in exercise (eg physical therapists). Conclusions: These data support the importance of understanding how to provide exercise information to persons with MS and identifying that health-care providers including neurologists and physical therapists should be involved in exercise promotion

Immunoregulatory effects of testosterone supplementation combined with exercise training in men with Inclusion Body Myositis: A double‐blind, placebo‐controlled, cross‐over trial

Objectives Sporadic Inclusion Body Myositis (IBM) is an inflammatory muscle disease affecting individuals over the age of 45, leading to progressive muscle wasting, disability and loss of independence. Histologically, IBM is characterised by immune changes including myofibres expressing major histocompatibility complex molecules and invaded by CD8+ T cells and macrophages, and by degenerative changes including protein aggregates organised in inclusion bodies, rimmed vacuoles and mitochondrial abnormalities. There is currently no cure, and regular exercise is currently the only recognised treatment effective at limiting muscle weakening, atrophy and loss of function. Testosterone exerts anti-inflammatory effects, inhibiting effector T-cell differentiation and pro-inflammatory cytokine production. Methods We conducted a double-blind, placebo-controlled, cross-over trial in men with IBM, to assess whether a personalised progressive exercise training combined with application of testosterone, reduced the inflammatory immune response associated with this disease over and above exercise alone. To assess intervention efficacy, we immunophenotyped blood immune cells by flow cytometry, and measured serum cytokines and chemokines by Luminex immunoassay. Results Testosterone supplementation resulted in modest yet significant count reduction in the classical monocyte subset as well as eosinophils. Testosterone-independent immunoregulatory effects attributed to exercise included altered proportions of some monocyte, T- and B-cell subsets, and reduced IL-12, IL-17, TNF-α, MIP-1β and sICAM-1 in spite of interindividual variability. Conclusion Overall, our findings indicate anti-inflammatory effects of exercise training in IBM patients, whilst concomitant testosterone supplementation provides some additional changes. Further studies combining testosterone and exercise would be worthwhile in larger cohorts and longer testosterone administration periods

Exercise training for multiple sclerosis: A narrative review of history, benefits, safety, guidelines, and promotion

Background: There have been significant advances in the medical treatment and management of multiple sclerosis pathogenesis, relapse and disease progression over the past 30 years. There have been advancements in the symptomatic treatment of multiple sclerosis, including management of secondary multiple sclerosis expressions such as walking, cognitive dysfunction, fatigue and depression. Scientific evidence and expert opinion suggest that exercise may be the single most effective non-pharmacological symptomatic treatment for multiple sclerosis. This article presents the historical context of exercise training within the multidisciplinary management of multiple sclerosis. We guide neurologists and healthcare providers on the recommended prescription of exercise and practical, theoretical methods to overcome barriers to exercise. Method: We undertook a critical search of the historical and current literature regarding exercise and multiple sclerosis from the viewpoint of exercise promotion by neurologists and the multidisciplinary care team. Results: We highlight the ever-strengthening body of research indicating that exercise is safe and effective for improving symptoms of multiple sclerosis. Further, exercise training may be necessary for reducing disease progression. Conclusion: We seek to encourage neurologists and specialists in multidisciplinary healthcare teams to prescribe and promote exercise at diagnosis and across all stages of the disease trajectory using prescriptive guidelines as part of comprehensive MS care. Available tools include clinical education to dispel any historical myths related to exercise in multiple sclerosis, clinical exercise guidelines and behaviour change theory to overcome patients barriers to exercise

Exercise is good medicine

If your healthcare provider suggested an approach for managing your MS that could improve aerobic capacity, balance, depression, fatigue, muscular strength, quality of life, and walking mobility, would you choose it? Can exercise provide such benefits and be "good medicine" in MS? The answer seems to be, "Yes!

Approaches to increasing physical activity for people with neurological conditions – Insights from the multiple sclerosis literature

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Neurological disability and its association with walking impairment in multiple sclerosis: Brief review

Neurological disability and walking impairment are two common, co-varying consequences of multiple sclerosis (MS) that can result in substantial patient burden for daily activities and quality of life. Indeed, neurological disability and walking impairment are driven by pathological changes in the central nervous system, and measurement of walking function is a common method of monitoring the progression of disease and neurological disability. The existing data indicate that the presence of walking impairments range from performance through real-world outcomes based on comparison of MS versus healthy controls, and walking impairments become worse with increasing severity of neurological disability (i.e., progression). Accordingly, researchers and clinicians have considered both pharmaceutical and rehabilitation approaches for managing walking impairment in MS. Both approaches yield beneficial effects on walking outcomes, although the majority of research has focused on exercise training rather than pharmaceutical interventions. Overall, this underscores the importance of continued efforts toward identifying approaches for preventing, forestalling and restoring walking function in persons with MS across the spectrum of neurological disability and its progression