Visually Impaired OLder people’s Exercise programme for falls prevenTion (VIOLET): a feasibility study

Abstract

Visually Impaired OLder people’s Exercise programme for falls prevenTion (VIOLET): a feasibility study Nicola Adams,1* Dawn Skelton,2 Cathy Bailey,1 Denise Howel,3 Dorothy Coe,1 Rosy Lampitt,4 Jennifer Wilkinson,4 Tony Fouweather,3 Lex de Jong,2 Sheena Gawler,1 Vincent Deary,1 Joanne Gray,1 Heather Waterman5 and Steve Parry6 1Faculty of Health and Life Sciences, Northumbria University, Newcastle upon Tyne, UK 2Institute of Applied Health Research, School of Health and Life Sciences, Centre for Living, Glasgow Caledonian University, Glasgow, UK 3Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK 4Newcastle Clinical Trials Unit, Newcastle University, Newcastle upon Tyne, UK 5Healthcare Sciences, Cardiff University, Cardiff, UK 6Institute for Ageing and Health, Newcastle University, Newcastle upon Tyne, UK *Corresponding author [email protected] Background: Visually impaired older people (VIOP) have a higher risk of falling and are likely to avoid activity. Objectives: To adapt the existing Falls Management Exercise (FaME) programme, which is delivered in the community, for VIOP and to investigate the feasibility of conducting a definitive randomised controlled trial of this adapted intervention. Design: Phase I – consultation with stakeholders to adapt the FaME programme. Two focus groups were conducted, each with 10 VIOP across the study sites. Phase II – two-centre randomised pilot trial and economic evaluation of the adapted FaME programme for VIOP versus usual care. Phases III and IV – qualitative interviews with VIOP and Postural Stability Instructors (PSIs) regarding their views and experiences of the research process, undertaking the intervention and its acceptability. Intervention: This was adapted from the group-based FaME programme. A 1-hour exercise programme ran weekly over 12 weeks at the study sites (Newcastle and Glasgow) and was delivered by third-sector organisations. Participants were advised to also exercise at home for 2 hours per week. Those randomised to the usual activities group received no intervention. Outcome measures: These were completed at baseline, week 12 and week 24. The primary potential outcome measure used was the Short Form Falls Efficacy Scale – International. Secondary outcome assessment measures were activity avoidance, current activity, balance/falls risk, physical activity, loneliness, anxiety and depression, work and social adjustment, quality of life and economic costs. Participants’ compliance was assessed by reviewing attendance records and self-reported compliance with the home exercises. PSIs’ compliance with the course content (fidelity) was assessed by a researcher attending a sample of exercise sessions. Adverse events were collected in a weekly telephone call. Findings: An adapted exercise programme was devised with stakeholders. In the pilot trial, 82 participants drawn from community-living VIOP were screened, 68 met the inclusion criteria and 64 were randomised, with 33 allocated to the intervention and 31 to the usual activities arm. A total of 94% of participants DOI: 10.3310/phr05XXX PUBLIC HEALTH RESEARCH 2018 VOL. 5 NO. XX © Queen’s Printer and Controller of HMSO 2018. This work was produced by Adams et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK. UNCORRECTED PROOF DATE: 07/20/2018 FILE: 12-181-07-2P.pdf v provided data at week 12 and 92% at week 24. Adherence to the study was high. The intervention was found to be both safe and acceptable to participants, with 76% attending nine or more classes. Median time for home exercise was 50 minutes per week. There was little or no evidence that fear of falling, exercise, attitudinal or quality-of-life outcomes differed between trial arms at follow-up. Thematic analysis of the interviews with VIOP participants identified facilitators of and barriers to exercise, including perceived relevance to health, well-being and lifestyle, social interaction, self-perception and practical assistance. PSIs identified issues regarding level of challenge and assistance from a second person. Limitations: The small sample size and low falls risk of the study sample are study limitations. Conclusion: Although adaptation, recruitment and delivery were successful, the findings indicated that VIOP with low to moderate falls risk could be integrated into mainstream programmes with some adaptations. A future definitive trial should consider graduated exercises appropriate to ability and falls risk within mainstream provision. Other outcome measures may additionally be considered. Trial registration: Current Controlled Trials ISRCTN16949845. Funding: This project was funded by the NIHR Public Health Research programme and will be published in full in Public Health Research; Vol. 6, No. X. See the NIHR Journals Library website for further project information. ABSTRACT NIHR Journals Library www.journalslibrary.nihr.ac.uk UNCORRECTED PROOF DATE: 07/20/2018 FILE: 12-181-07-2P.pdf vi