The development and testing of a novel intervention (Mii-vitaliSe) to support people with Multiple Sclerosis to be active - a pilot evaluation Louise Fazakarley Bournemouth University August 2018 A thesis submitted in partial fulfilment of the requirements of Bournemouth University for the degree of Doctor of Philosophy Copyright statement This copy of this thesis has been supplied on condition that anyone who consults it is understood to recognise that its copyright rests with the author and due acknowledgement must always be made of the use of any material, contained in or derived from the thesis. ii Abstract-Louise Fazakarley Title The development and testing of a novel intervention (Mii-vitaliSe) to support people with Multiple Sclerosis (MS) to be active - a pilot evaluation. Background There are many benefits of physical activity for people with MS, but also barriers to participation. Active home gaming might help to maintain enthusiasm to exercise over the longer term. Pilot research in the USA suggested the Wii™ can be used safely at home by mobile people with MS. Aims To develop and conduct preliminary testing of a home-based physiotherapist- supported Wii™ intervention (Mii-vitaliSe) for people with MS. Trial design A mixed method study incorporating service user involvement throughout. Mii- vitaliSe (incorporates off-the-shelf Wii™ software, physiotherapist support and resource materials) was developed and piloted Methods A mixed methods wait-list parallel arm randomised controlled trial. Thirty ambulatory people with moderate MS were randomised to receive Mii-vitaliSe (incorporating off-the-shelf Wii™ software, physiotherapist support and resource materials) either immediately (for 12 months) or after a 6 month delay (for 6 months). Outcomes included assessments of balance, gait, mobility, hand dexterity, activity levels and adherence at baseline, 6 and 12 months. Interviews (n=25) sought participants’ experiences of taking part and physiotherapists’ (n=2) feedback. Results Recruitment (31%), screening and data collection (97% complete data at six months) procedures worked well and participants found randomisation to a delayed group acceptable. Preliminary estimates of effect size were calculated for the outcome iii measures and the largest (d=0.41) positive effect found for the iTUG (instrumented Timed Up and Go). On average participants used the Wii™ twice a week for 30 minutes. Some continued to use the Wii™ for 12 months. Support and advice from the intervention resources were perceived to be helpful and a range of physical and psychological benefits reported. Conclusions A novel intervention using the Wii™ has been developed and undergone feasibility testing. Mii-vitaliSe offers a way for people with MS to increase physical activity levels but requires further development and evaluation. Trial registration number ISRCTN42534180 Funding The study was funded by a project grant awarded by the UK Multiple Sclerosis Society (Reference number 933/10) iv Chapter 1 Introduction ............................................................................................ 1 1.1 Overview ...................................................................................................... 1 1.2 My personal background .............................................................................. 2 1.3 My contribution ............................................................................................ 2 1.3.1 Developing ............................................................................................. 5 1.3.2 Delivering ............................................................................................... 6 1.3.3 Evaluating .............................................................................................. 6 1.4 Outline of the thesis and chapter outline ...................................................... 7 Chapter 2 Background .......................................................................................... 10 2.1 Introduction ................................................................................................ 10 2.2 Epidemiology ............................................................................................. 10 2.3 Aetiology .................................................................................................... 11 2.4 Diagnosis .................................................................................................... 11 2.5 Pathology ................................................................................................... 11 2.6 Signs and symptoms ................................................................................... 12 2.7 Multi-disciplinary management ................................................................. 12 2.8 Self-management........................................................................................ 13 2.9 Physiotherapy ............................................................................................. 13 2.10 Physical activity in people with MS .......................................................... 14 2.11 Summary .................................................................................................... 14 Chapter 3 Literature review .................................................................................. 16 3.1 Benefits of physical activity in people with MS ........................................ 18 3.2 Safety of exercise for people with MS ....................................................... 22 3.3 Levels of activity in people with MS ......................................................... 23 3.4 Causes of low activity levels in people with MS ....................................... 24 3.5 The rationale for Virtual Reality and active gaming .................................. 25 3.6 Rationale for the Nintendo Wii™ as a tool to increase physical activity .. 28 v 3.7 Evidence for the Nintendo Wii™ as a tool for increasing physical activity for people with a long-term condition .................................................................... 31 3.8 Safety considerations and appropriateness of the Wii™ ........................... 34 3.9 What is the evidence base for using the Wii™ to increase physical activity levels for people with MS? .................................................................................... 35 3.9.1 Randomised controlled trials ............................................................... 36 3.9.2 Pilot studies .......................................................................................... 37 3.9.3 Qualitative findings .............................................................................. 40 3.10 Behaviour change techniques to support physical activity ........................ 45 3.10.1 Social Cognitive Theory ...................................................................... 46 3.10.2 The Health Action Process Approach .................................................. 47 3.10.3 Motivational interviewing (MI) ........................................................... 49 3.10.4 Self-Determination Theory .................................................................. 50 3.11 Future research/need for this study ............................................................ 51 3.12 Research Questions .................................................................................... 54 3.13 Research aims............................................................................................. 54 Chapter 4 Development of the Mii-vitaliSe resource materials ........................... 55 4.1 Literature review ........................................................................................ 55 4.2 Existing materials and resources ................................................................ 56 4.2.1 Wii-habilitation resources .................................................................... 56 4.2.2 The Chartered Society of Physiotherapy.............................................. 56 4.2.3 Nintendo Wii™ guidance .................................................................... 57 4.2.4 Exercise pamphlets............................................................................... 57 4.2.5 Guidance from Multiple Sclerosis Societies ........................................ 57 4.2.6 Games Analysis .................................................................................... 58 4.3 Intervention Development Group .............................................................. 58 4.4 Patient and Public Involvement (PPI) ........................................................ 59 4.4.1 Consultation workshop ........................................................................ 59 4.5 Key messages from the service user consultation ...................................... 65 vi 4.5.1 Patterns of use ...................................................................................... 65 4.5.2 Safety.................................................................................................... 66 4.5.3 Commitment and goal setting .............................................................. 68 4.5.4 Benefits and drawbacks........................................................................ 68 4.5.5 Problems identified and solutions for overcoming them ..................... 70 4.5.6 Factors that contributed to ongoing use of the Wii™ .......................... 71 4.5.7 Software ..............................................................................................