Feasibility of trial procedures for a randomised controlled trial of a community based group exercise intervention for falls prevention for visually impaired older people: the VIOLET study

Nicola Adams, Dawn A Skelton, Denise Howel, Cathy Bailey, Rosie Lampitt, Tony Fouweather, Joanne Gray, Dorothy Coe, Jennifer Wilkinson, Sheena Gawler, Lex D de Jong, Heather Waterman, Vincent Deary, Michael Clarke, Steve W. Parry

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Abstract

Background: Visually impaired older people (VIOP) have a higher risk of falling than their sighted peers and are likely to avoid physical activity. The aim was to investigate the feasibility of conducting a definitive randomised controlled trial (RCT) of an adaptation of the Falls Management Exercise Programme (FaME) for VIOP, delivered in the community.
Methods: Two-centre randomised pilot trial and economic evaluation of the adapted group-based FaME programme for VIOP versus usual care. A one hour exercise programme ran weekly over 12 weeks at the study sites (Newcastle and Glasgow), delivered by voluntary and community organisations. Participants were advised to exercise at home for an additional two hours over the week. Those randomised to the usual activities group received no intervention. Outcome measures were completed at baseline, 12 and 24 weeks. The potential primary outcome was the Short Form Falls Efficacy Scale - International (SFES-I). Participants' adherence was assessed by reviewing attendance records and selfreported compliance to the home exercises. Adherence with course content (fidelity) by instructors was assessed by a researcher. Adverse events were collected in a weekly phone call.
Results: 82 participants, drawn from community-living VIOP were screened; 68 met the inclusion criteria; 64 participants were randomised with 33 allocated to the intervention and 31 to the usual activities arm. 94% of participants provided data at the 12 week visit and 92% at 24 weeks. Adherence was high. The intervention was found to be both safe 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, balance and falls risk, physical activity, emotional, attitudinal or quality of life outcomes differed between trial arms at follow-up.
Conclusions: The intervention, FaME, was implemented successfully for VIOP and all progression criteria for a main trial were met. The lack of difference between groups was unsurprising, given it was a pilot study, but there may have been other contributory
factors including suboptimal exercise dose and apparent low risk of falls in participants. These issues need addressing for a future trial.
Original languageEnglish
JournalBMC Geriatrics
DOIs
Publication statusPublished - 12 Dec 2018

Keywords

  • falls prevention
  • intervention
  • exercise
  • vision
  • visual impairment
  • feasibility study

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    Adams, N., Skelton, D. A., Howel, D., Bailey, C., Lampitt, R., Fouweather, T., Gray, J., Coe, D., Wilkinson, J., Gawler, S., de Jong, L. D., Waterman, H., Deary, V., Clarke, M., & Parry, S. W. (2018). Feasibility of trial procedures for a randomised controlled trial of a community based group exercise intervention for falls prevention for visually impaired older people: the VIOLET study. BMC Geriatrics. https://doi.org/10.1186/s12877-018-0998-6