Feasibility of Trial Procedures for a Randomised Controlled Trial of a Community Based Group Exercise Intervention for Falls Prevention in Visually Impaired Older People: The VIOLET Study

Nicola Adams, Dawn A. Skelton, Denise Howel, Catherine Bailey, Rosy Lampitt, Tony Fouweather, Joanne Gray, Dorothy Coe, Jennifer Wilkinson, Sheena Gawler, Lex D. de Jong, Heather Waterman, Vincent Deary, Michael Clarke, Steve 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 adapt the existing Falls Management Exercise (FaME) programme for VIOP, delivered in the community, and to investigate the feasibility of conducting a definitive randomised controlled trial (RCT) of this adapted intervention.

Methods
Two-centre randomised mixed methods 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 self-reported compliance to the home exercises. Adherence with the 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 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 on fear of falling 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
Article number307
Number of pages15
JournalBMC Geriatrics
Volume18
DOIs
Publication statusPublished - 12 Dec 2018

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