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Finding the right balance with participation in exercise and sport for individuals with multiple sclerosis: protocol for a pre and post intervention feasibility study.

ABSTRACT: INTRODUCTION:Individuals with minimal disability from multiple sclerosis (MS) requested advice on finding the right balance, between too much and too little exercise, when participating in their choice of sport or exercise. To optimise exercise participation during the early stages of the disease, a flexible exercise participation programme (FEPP) has been developed. The FEPP is novel because it provides guidance and support for individuals with MS to participate and progress in their preferred sport or exercise. The primary objective was to assess the feasibility of the FEPP. The secondary objective was to assess the feasibility of a larger trial to demonstrate the efficacy of the FEPP. METHODS AND ANALYSIS:A stage I feasibility study of the FEPP, using a single group preintervention/post-intervention design, will be conducted with 16 participants with minimal disability from MS (Expanded Disability Status Scale level of 0-3.5). The 12-week FEPP will guide participants to independently participate in their preferred sport or exercise at a location of their choice. Exercise progression will be guided by individual energy levels and a weekly telephone coaching session with a physiotherapist. Participation in exercise or sport will be recorded in parallel with assessment of disease biomarkers (plasma cytokines interleukin (IL)-2, IL-4, IL-6, IL-10, interferon (IFN)-? and tumour necrosis factor (TNF)), subjective vitality and high-level mobility. Acceptability of the FEPP will be assessed using a sequential explanatory mixed methods design where the findings of a participant survey will inform the interview guide for a series of focus groups.Feasibility of a larger trial will be assessed via process, resources, management and scientific metrics. Progression to a larger trial will depend on the achievement of specified minimum success criteria. ETHICS AND DISSEMINATION:Ethical approval has been obtained for this study from the James Cook University Human Research Ethics Committee (H7956). Dissemination of findings is planned via peer-reviewed journals, conference presentations and media releases. The protocol date was 21 December 2019, V.1. TRIAL REGISTRATION NUMBER:The trial is registered with Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN12620000076976.

SUBMITTER: Smith M

PROVIDER: S-EPMC7150603 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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Finding the right balance with participation in exercise and sport for individuals with multiple sclerosis: protocol for a pre and post intervention feasibility study.

Smith Moira M Williams Gavin G Barker Ruth R

BMJ open 20200318 3

<h4>Introduction</h4>Individuals with minimal disability from multiple sclerosis (MS) requested advice on finding the right balance, between too much and too little exercise, when participating in their choice of sport or exercise. To optimise exercise participation during the early stages of the disease, a flexible exercise participation programme (FEPP) has been developed. The FEPP is novel because it provides guidance and support for individuals with MS to participate and progress in their <i ...[more]

PMID: 32193273

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Project description:BackgroundBalance, mobility impairments and falls are problematic for people with multiple sclerosis (MS). The "Balance Right in MS (BRiMS)" intervention, a 13-week home and group-based exercise and education programme, aims to improve balance and minimise falls. This study aimed to evaluate the feasibility of undertaking a multi-centre randomised controlled trial and to collect the necessary data to design a definitive trial.MethodsThis randomised controlled feasibility study recruited from four United Kingdom NHS clinical neurology services. Patients ≥ 18 years with secondary progressive MS (Expanded Disability Status Scale 4 to 7) reporting more than two falls in the preceding 6 months were recruited. Participants were block-randomised to either a manualised 13-week education and exercise programme (BRiMS) plus usual care, or usual care alone. Feasibility assessment evaluated recruitment and retention rates, adherence to group assignment and data completeness. Proposed outcomes for the definitive trial (including impact of MS, mobility, quality of life and falls) and economic data were collected at baseline, 13 and 27 weeks, and participants completed daily paper falls diaries.ResultsFifty-six participants (mean age 59.7 years, 66% female, median EDSS 6.0) were recruited in 5 months; 30 randomised to the intervention group. Ten (18%) participants withdrew, 7 from the intervention group. Two additional participants were lost to follow up at the final assessment point. Completion rates were > 98% for all outcomes apart from the falls diary (return rate 62%). After adjusting for baseline score, mean intervention-usual care between-group differences for the potential primary outcomes at week 27 were MS Walking Scale-12v2: - 7.7 (95% confidence interval [CI] - 17.2 to 1.8) and MS Impact Scale-29v2: physical 0.6 (CI - 7.8 to 9), psychological - 0.4 (CI - 9.9 to 9). In total, 715 falls were reported, rate ratio (intervention:usual care) for falls 0.81 (0.41 to 2.26) and injurious falls 0.44 (0.41 to 2.23).ConclusionsProcedures were practical, and retention, programme engagement and outcome completion rates satisfied a priori progression criteria. Challenges were experienced in completion and return of daily falls diaries. Refinement of methods for reporting falls is therefore required, but we consider a full trial to be feasible.Trial registrationISRCTN13587999 Date of registration: 29 September 2016.

Project description:Impaired mobility is a cardinal feature of multiple sclerosis (MS) and is rated by people with MS as their highest priority. By the secondary progressive phase, balance, mobility and physical activity levels are significantly compromised; an estimated 70% of people with secondary progressive MS fall regularly. Our ongoing research has systematically developed 'Balance Right in MS' (BRiMS), an innovative, manualised 13-week guided self-management programme tailored to the needs of people with MS, designed to improve safe mobility and minimise falls. Our eventual aim is to assess the clinical and cost effectiveness of BRiMS in people with secondary progressive MS by undertaking an appropriately statistically powered, multi-centre, assessor-blinded definitive, randomised controlled trial. This feasibility study will assess the acceptability of the intervention and test the achievability of running such a definitive trial.This is a pragmatic multi-centre feasibility randomised controlled trial with blinded outcome assessment. Sixty ambulant people with secondary progressive MS who self-report two or more falls in the previous 6 months will be randomly allocated (1:1) to either the BRiMS programme plus usual care or to usual care alone. All participants will be assessed at baseline and followed up at 15 weeks and 27 weeks post-randomisation. The outcomes of this feasibility trial include:Feasibility outcomes, including trial recruitment, retention and completionAssessment of the proposed outcome measures for the anticipated definitive trial (including measures of walking, quality of life, falls, balance and activity level)Measures of adherence to the BRiMS programmeData to inform the economic evaluation in a future trialProcess evaluation (assessment of treatment fidelity and qualitative evaluation of participant and treating therapist experience).The BRiMS intervention aims to address a key concern for MS service users and providers. However, there are several uncertainties which need to be addressed prior to progressing to a full-scale trial, including acceptability of the BRiMS intervention and practicality of the trial procedures. This feasibility trial will provide important insights to resolve these uncertainties and will enable a protocol to be finalised for use in the definitive trial.ISRCTN13587999.

Project description:Aims: Recent research suggests that aerobic exercise can be performed safely within the first week following a concussion injury and that early initiation of exercise may speed recovery. To better understand the physiological changes during a concussion, we tested the hypothesis that mild-to-intense exercise testing can be performed within days immediately following injury, and can be used to discern differences between the concussed and normal healthy state. Thus, the purpose was to observe the cerebral hemodynamic responses to incremental exercise testing performed acutely post-concussion in high-performance athletes. Methods: This study was a within- and between-experimental design, with seven male university ice hockey teams participating. A subgroup of five players acted as control subjects (CON) and was tested at the same time as the 14 concussed (mTBI) players on Day 2, 4, and 7 post-concussion. A 5-min resting baseline and 5-min exercise bouts of mild (EX1), moderate (EX2), and high (EX3) intensity exercise were performed on a cycle ergometer. Near-infrared spectroscopy was used to monitor pre-frontal cortex oxy-haemoglobin (HbO2), deoxy-haemoglobin (HHb), and total blood volume (tHb) changes. Results: ANOVA compared differences between testing days and groups, and although large percentage changes in HbO2 (20-30%), HHb (30-40%), and tHb (30-40%) were recorded, no significant (p ? 0.05) differences in cerebral hemodynamics occurred between mTBI vs. CON during aerobic exercise testing on any day post-injury. Furthermore, there was a linear relationship between exercise intensity vs. cerebral hemodynamics during testing for each day (r 2 = 0.83-0.99). Conclusion: These results demonstrate two novel findings: (1) mild-to-intense aerobic exercise testing can be performed safely as early as Day 2 post-concussion injury in a controlled laboratory environment; and (2) evidence-based objective measures such as cerebral hemodynamics can easily be collected using near-infrared spectroscopy (NIRS) to monitor physiological changes during the first-week post-injury. This research has important implications for monitoring physiological recovery post-injury and establishing new rehabilitation guidelines.

Project description:AimAs sport and physical activity are vital to support extended health spans, this study aimed to analyse the current trends in sports participation and physical activity rates among individuals aged 65 years and older in Scotland. Data were compared with the Chief Medical Officer (CMO) guidelines and analysed the influence of key factors on participation rates.MethodsThe study used data from the Scottish Health Survey and the Scottish Household Survey (2019) to investigate self-reported participation in physical activity and sports across different age groups. Descriptive statistics and cross-tabulations were used to analyse the relationships between participation rates and influencing factors. Participation data for Parkrun events in Scotland were also analysed for the years 2008-2018.ResultsThe study found a clear decline in sports participation with age, with a steep decline after the age of 65, particularly in women. The majority of participation among individuals aged 65+ was in walking, with a sport participation rate of only 31.2% when walking was excluded. Physical activity and sport participation was lower in women across all age ranges but particularly so in the 75+ age group. The most popular sporting activities in the older age group were keep fit/aerobics, swimming and golf. Additionally, the study found that social deprivation had a major impact on sports participation rates, with the most deprived households exhibiting the lowest participation levels irrespective of age. The prevalence of loneliness was lower among individuals who participated in sports or adhered to the CMO guidelines for moderate/vigorous physical activity and strength-building exercises.DiscussionThe findings of this study have implications for promoting physical activity and sports participation among older adults, particularly in deprived communities. This study highlights the importance of balance exercises within sport and the need for more targeted efforts to increase participation rates among older adults. The study also emphasizes the positive impact of sports participation on reducing loneliness among older adults. Overall, the findings suggest the need for ongoing efforts to promote physical activity and sports participation among older adults to improve their overall health and well-being.

Dataset Information

Finding the right balance with participation in exercise and sport for individuals with multiple sclerosis: protocol for a pre and post intervention feasibility study.

Publications

Finding the right balance with participation in exercise and sport for individuals with multiple sclerosis: protocol for a pre and post intervention feasibility study.

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