H Gunn1, K N Stevens2,3, S Creanor2,4, J Andrade5, L Paul6, L Miller7, C Green8, P Ewings9, A Barton10, M Berrow2, J Vickery2, B Marshall11, J Zajicek12, J A Freeman11. 1. Faculty of Health, School of Health Professions, Peninsula Allied Health Centre, University of Plymouth, Derriford Road, Plymouth, PL6 8BH, England. hilary.gunn100@plymouth.ac.uk. 2. Faculty of Health, Medical Statistics Group, Room N15, Plymouth Science Park, Plymouth, PL6 8BX, England. 3. Peninsula Clinical Trials Unit, University of Plymouth, Room N16, Plymouth Science Park, Plymouth, PL6 8BX, England. 4. University of Exeter Medical School, College of Medicine & Health, University of Exeter, Exeter, England. 5. Faculty of Health, School of Psychology, University of Plymouth, Portland Square Building, Drake Circus Campus, Plymouth, PL4 8AA, England. 6. School of Health & Life Sciences, Glasgow Caledonian University, Cowcaddens Road, Glasgow, G4 0BA, Scotland. 7. Douglas Grant Rehabilitation Unit, Ayrshire Central Hospital, Kilwinning Road, Irvine, KA12 8SS, Scotland. 8. University of Exeter Medical School, Health Economics Group, University of Exeter, St. Luke's Campus, Exeter, EX1 2LU, England. 9. NIHR Research Design Service (South West), Musgrove Park Hospital, Taunton, TA1 5DA, England. 10. Faculty of Medicine and Dentistry, NIHR Research Design Service South West, ITTC Building, Plymouth Science Park, Plymouth, PL6 8BX, England. 11. Faculty of Health, School of Health Professions, Peninsula Allied Health Centre, University of Plymouth, Derriford Road, Plymouth, PL6 8BH, England. 12. School of Medicine, Medical and Biological Sciences, University of St. Andrews, North Haugh, St. Andrews, KY16 9TF, Scotland.
Abstract
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.
RCT Entities:
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.
Authors: Hilary Gunn; Sophie Markevics; Bernhard Haas; Jonathan Marsden; Jennifer Freeman Journal: Arch Phys Med Rehabil Date: 2015-06-10 Impact factor: 3.966
Authors: A Carter; A Daley; L Humphreys; N Snowdon; N Woodroofe; J Petty; A Roalfe; J Tosh; B Sharrack; J M Saxton Journal: Mult Scler Date: 2014-01-13 Impact factor: 6.312
Authors: H Gunn; J Andrade; L Paul; L Miller; S Creanor; C Green; J Marsden; P Ewings; M Berrow; J Vickery; A Barton; B Marshall; J Zajicek; J A Freeman Journal: Pilot Feasibility Stud Date: 2017-07-27
Authors: Sarah Thomas; Peter W Thomas; Paula Kersten; Rosemary Jones; Colin Green; Alison Nock; Vicky Slingsby; Angela Davies Smith; Roger Baker; Kathleen T Galvin; Charles Hillier Journal: J Neurol Neurosurg Psychiatry Date: 2013-05-21 Impact factor: 10.154
Authors: Marie Kierkegaard; Elizabeth Peterson; Susanna Tuvemo Johnson; Kristina Gottberg; Sverker Johansson; Marie Elf; Maria Flink; Charlotte Ytterberg Journal: BMJ Open Date: 2022-07-08 Impact factor: 3.006