View metadata, citation and similarDownloaded papers at core.ac.uk from http://bmjopen.bmj.com/ on October 16, 2017 - Published by group.bmj.com brought to you by CORE provided by Bournemouth University Research Online Open Access Research Mii-vitaliSe: a pilot randomised controlled trial of a home gaming system (Nintendo Wii) to increase activity levels, vitality and well-being in people with multiple sclerosis Sarah Thomas,1 Louise Fazakarley,1 Peter W Thomas,1 Sarah Collyer,2 Sarah Brenton,2 Steve Perring,3 Rebecca Scott,4 Fern Thomas,1 Charlotte Thomas,1 Kelly Jones,5 Jo Hickson,5 Charles Hillier2 To cite: Thomas S, ABSTRACT Strengths and limitations of this study Fazakarley L, Thomas PW, et al. Objectives While the health and well-being benefits of Mii-vitaliSe: a pilot randomised physical activity are recognised, people with multiple controlled trial of a home ► Used a randomised controlled trial design and sclerosis (MS) often face greater barriers than the general gaming system (Nintendo Wii) to included mixed methods and a consideration of population. The Nintendo Wii potentially offers a fun, increase activity levels, vitality long-term follow-up. convenient way of overcoming some of these. The aim and well-being in people with ► Adherence to the Mii-vitaliSe intervention was multiple sclerosis. BMJ Open was to test the feasibility of conducting a definitive trial of assessed by daily completion of a log. 2017;7:e016966. doi:10.1136/ the effectiveness and cost-effectiveness of Mii-vitaliSe; ► Mii-vitaliSe incorporated home-based use, bmjopen-2017-016966 a home-based, physiotherapist-supported Nintendo Wii personalised support and behaviour change intervention. ► Prepublication history and techniques. additional material for this Design A single-centre wait-list randomised controlled ► Physical outcome assessments were not undertaken paper are available online. To study. blinded to group allocation. view these files please visit the Setting MS service in secondary care. ► Feasibility focus paves way for a definitive trial of the journal online (http:// dx. doi. Participants Ambulatory, relatively inactive people with effectiveness and cost-effectiveness of Mii-vitaliSe. org/ 10. 1136/ bmjopen- 2017- clinically confirmed MS. 016966). Intervention Thirty participants were randomised to receive Mii-vitaliSe either immediately (for 12 months) or Received 24 March 2017 ISRCTN49286846 Revised 5 May 2017 after a 6-month wait (for 6 months). Mii-vitaliSe consisted Trial registration Accepted 8 May 2017 of two supervised Nintendo Wii familiarisation sessions in the hospital followed by home use (Wii Sports, Sports Resort and Fit Plus software) with physiotherapist support and personalised resources. INTRODUCTION Outcomes Included self-reported physical activity levels, It is now widely recognised that physical quality of life, mood, self-efficacy, fatigue and assessments activity provides many benefits for people with of balance, gait, mobility and hand dexterity at baseline, 6 multiple sclerosis.1 2 These include improve- and 12 months. Interviews (n=25) explored participants’ ments in physical fitness, mobility, muscle experiences and, at study end, the two Mii-vitaliSe strength as well as possible secondary bene- 1 Bournemouth University, facilitators’ experiences of intervention delivery (main fits such as improved quality of life, mood Faculty of Health and Social qualitative findings reported separately). and well-being.3–7 Recent research suggests Sciences, Bournemouth, Dorset, Results Mean (SD) age was 49.3 (8.7) years, 90% female, UK exercise is safe for people with MS with no with 47% diagnosed with MS <6 years ago and 60% new 2Poole Hospital NHS Foundation increased risk of relapse or adverse events to active gaming. The recruitment rate was 31% (95% CI Trust, Dorset Multiple Sclerosis (AEs).8 However, people with MS typically are Service, Poole, Dorset, UK 20% to 44%). Outcome data were available for 29 (97%) 3 much less physically active than the general Poole Hospital NHS Foundation at 6 months and 28 (93%) at 12 months. No serious 9 Trust, Medical Physics, Poole, adverse events were reported during the study. Qualitative population. Keeping physically active can Dorset, UK data indicated that Mii-vitaliSe was well-received. Mean be challenging and people with MS face 2 10–13 4National Star College, Wii use across both groups over the initial 6-month additional barriers. These include phys- Cheltenham, Gloucestershire, UK ical (eg, pain, fatigue, mobility and balance 5 intervention period was twice a week for 27 min/day. Mean Service user, Bournemouth, UK cost of delivering Mii-vitaliSe was £684 per person. limitations, overheating), psychological (eg, Correspondence to Discussion Mii-vitaliSe appears acceptable and a future fear, embarrassment or lack of confidence) Dr Sarah Thomas; trial feasible and warranted. These findings will inform its and environmental (eg, transport, cost, lack saraht@ bournemouth. ac. uk design. of suitable facilities/trained staff) barriers. Thomas S, et al. BMJ Open 2017;7:e016966. doi:10.1136/bmjopen-2017-016966 1 Downloaded from http://bmjopen.bmj.com/ on October 16, 2017 - Published by group.bmj.com Open Access The Wii potentially overcomes some of these barriers Aim and objectives by offering a relatively inexpensive, convenient, immer- The main aim of this pilot study was to assess the accept- sive and fun way to exercise in the home.14 15 Recent ability and suitability of Mii-vitaliSe and to establish physical activity guidelines for MS suggest working whether a definitive multicentre randomised controlled towards achieving 30 min of moderate aerobic activity trial to assess effectiveness and cost-effectiveness is feasible twice a week and two sets of 10–15 repetitions of strength and, if so, to inform its design and conduct. training exercises twice a week.16 However, as noted by The specific objectives of the study were: de Souto Barreto, it is perhaps more important to get 1. Test procedures (including administration of the people who are currently inactive to do small amounts of self-reported outcomes and the physical assessments, activity even if they are not meeting guidelines for phys- delivery of the intervention, recording and monitoring ical activity.17 of AEs), estimate recruitment and retention rates, While applications of the Wii are diverse and find- and refine the selection of outcome measures in ings have been promising,14 18 the evidence base in MS preparation for a definitive randomised controlled is limited19 20 with most studies small, preliminary and trial. with limited follow-up.21–24 Nevertheless, early findings 2. Collect data on the variability of outcome measures to suggest the Wii is acceptable and enjoyable,25–27 safe for inform a sample size calculation for a larger trial. 21 3. Estimate adherence rates via a self-reported daily play home use for those with mild MS symptoms, might be log (in terms of frequency, intensity, duration). beneficial for balance24 26 and fitness21 and potentially 4. Determine the acceptability of study processes such as results in greater adherence than traditional rehabilita- randomisation and of the Mii-vitaliSe intervention to tion programmes.28 29 It has been suggested that active participants and obtain information about patterns of gaming might have a ‘gateway effect’ increasing individ- use/barriers to use. uals’ confidence and encouraging and enabling them to 30 5. Gather feedback from physiotherapists about their ex- engage in other physical activity. periences of delivering Mii-vitaliSe. In a non-randomised controlled trial (using a base- 6. Pilot a measure of healthcare resource use for a future line control period) involving a home-based Wii Fit economic evaluation. programme of 14 weeks’ duration, Plow and Finlayson reported that use of the Wii had declined at 14 weeks.21 They suggested that a more person-centred approach as METHODS well as the use of behaviour change techniques (such as Ethics and safety monitoring motivational interviewing and problem solving) might The trial was overseen by a steering committee and is help to improve longer term Wii use and foster intrinsic reported in accordance with the Consolidated Standards of Reporting Trials guidelines for pilot and feasibility motivation. They highlighted the importance of consid- 36 ering individuals’ functional levels, environment and studies. The study was reviewed and given a favourable 31 opinion by the National Health Service (NHS) South preferences when prescribing a Wii-Fit programme. Central Hampshire B Research Ethics Committee (ref: Findings from a scoping review of the exergaming 12/SC/0420). All participants gave written informed literature suggest the need for mixed methods trials consent before taking part. Poole Hospital NHS Foun- that incorporate long-term follow-up and follow patients dation Trust was the study sponsor. A Safety Monitoring from the clinical setting to the home.32 A recent system- Committee comprising two independent advisors (a atic review of behaviour change interventions to increase neurologist with expertise in MS and clinical trials and physical activity in people with MS concluded further a physiotherapist with expertise in risk assessment and research is required focusing on dose, long-term impact 33 management of service users with neurological disability) and method of delivery. Qualitative work undertaken reviewed any reported AEs and made recommendations in the USA suggests that people with MS would