Balance Right in Multiple Sclerosis (BRiMS): a feasibility randomised controlled trial of a falls prevention programme.

BACKGROUND: Balance, 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. METHODS: This 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. RESULTS: Fifty-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). CONCLUSIONS: Procedures 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 REGISTRATION: ISRCTN13587999 Date of registration: 29 September 2016.

Balance Right in Multiple Sclerosis (BRiMS): a guided self-management programme to reduce falls and improve quality of life, balance and mobility in people with secondary progressive multiple sclerosis: a protocol for a feasibility randomised controlled trial.

BACKGROUND: 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. METHODS/DESIGN: 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). DISCUSSION: 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. TRIAL REGISTRATION: ISRCTN13587999.

Polynuclear aromatic hydrocarbons in crops from long-term field experiments amended with sewage sludge.

This study reports on the polynuclear aromatic hydrocarbon (PAH) content of crop plants grown at three different field experiments where controlled additions of sewage sludge were made a number of years ago. Archived samples of several crops have been analysed from sludge-amended and unsludged control plots for 15 PAH compounds. Root crops and above ground plant parts were available for several years following the last applications of sludge. Although the soil PAH burden increased substantially due to sewage sludge additions, and residues of these compounds have persisted in the soils for many years, increased PAH concentrations relative to the unsludged controls were not consistently detected in plant tissues. Plant samples were relatively enriched with low molecular weight compounds such as acenaphthene/fluorene nd phenanthrene. Various lines of evidence indicate that PAHs detected in above ground plant parts are chiefly derived from atmospheric inputs, while PAHs detected in root crops probably arise from adsorption to the root surface.

The persistence of polynuclear aromatic hydrocarbons (PAHs) in sewage sludge amended agricultural soils.

In 1968, five metal enriched sewage sludges containing different concentrations of polynuclear aromatic hydrocarbons (PAHs) were applied to different plots on field soils at two experimental sites, Luddington and Lee Valley, in the UK. This resulted in substantial increases in the total PAH soil concentrations in all plots. Since application, losses have occurred, with the high molecular weight PAHs being more persistent. Calculated half-lives range from under 2 years for naphthalene to over 9 years for benzo[ghi]perylene and coronene. The losses of PAH compounds in these field experiments can be related, in part, to their physico-chemical properties, notably the octanol: water partition coefficient.

Trace element distribution and mobilization in Scottish soils with particular reference to cobalt, copper and molybdenum.

Total and extractable trace element contents have been determined in about 1000 soil profiles representing the main soil series occurring throughout Scotland. The frequency distributions of a number of trace elements in these soils are described and some relationships between total and extractable contents discussed. The geological nature of the soil parent material, soil texture, organic matter content and environmental contamination are the principal factors controlling soil total contents. Soil drainage class, because of its effect on mineral weathering and soil oxidation-reduction conditions, has a major influence on soil extractable contents, availability to plants and crop uptake. Particular attention is paid to cobalt, copper and molybdenum because of their importance for animal health in Scotland.