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

Abstract

BackgroundVisually 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.MethodsTwo-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 third sector (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.ResultsEighteen 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 min 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.ConclusionsThe 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.Trial registrationCurrent Controlled Trials ISRCTN ID: 16949845 Registered: 21 May 2015.

Health management service models for the elderly with visual impairment ： a scoping review

“…In contrast, a single strategy, such as only providing family reform suggestions, has not changed QoL [59], only providing reading training, has not changed the visual function of patients[56], and only providing daily exercise and directional and directional walking mobile training. The patient's emotional state, falls, and quality of life have not changed [37,57]. 90% of people who are blind or have poor vision still have some useable residual vision, which can bene t from professional low vision rehabilitation [93].…”

“…In developing countries, community-based health management is feasible [97]. In countries such as the UK [57,59], the focus on providing home-based services is more prominent, with more home exercise, home environment assessment, and modi cation so that older people with low vision in everyone's community can access rehabilitation services and reduce the incidence of falls. However, the cost of such training is usually not reimbursable by Medicare or private insurance in the USA[98].…”

“…Health management models of the elderly with VI . remote follow-up b. outpatient follow-up c. WeChat family follow-up d. home visit e. telephone followup; Environmental safety transformation: a. environmental assessment b. environmental transformation Referral and transfer treatment ; Psychological support: a. emotional support b. psychological counseling c. behavior activation therapy d. problem-solving therapy; Medical service appointment and reminder a. medical service appointment b. follow-up reminders.3.4 Health management strategies for the elderly with VIThe health management strategy for people with VI involves 9 topics, including self-management[35,37, 38,49], health education[40-42, 46, 47, 49-54], rehabilitation training[34, 36,37,39,[43][44][45][55][56][57][58][59][60][61][62][63][64], ophthalmic examination[35,41,42, 58, 63], evaluation[36,37,39,41, 58] and treatment[34,43,44, 48,55], regular follow-up[34-36, 41-43, 46, 48, 53, 54, 59], environmental safety improvement[38, 59-61], referral and transfer treatment[39,40,42,45, 48], psychological support[45, 46,49, 62], medical service appointment and reminder[34,41,45,51,53]. See Fig.2.…”

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

“…ADAPTED FALLS MANAGEMENT EXERCISE INTERVENTION VERSUS USUAL ACTIVITIES: FINDINGSNIHR Journals Library www.journalslibrary.nihr.ac.uk quartile; Max., maximum; Min., minimum; UQ, upper quartile.Adapted from with permission from Adams et al81 This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/ licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.…”

“…b Average frequency or duration for all weeks when participant reported exercising at home during intervention (note that these include zeros for weeks in which no exercise at home was done). Adapted from with permission from Adams et al81 This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.THE ADAPTED FALLS MANAGEMENT EXERCISE INTERVENTION VERSUS USUAL ACTIVITIES: FINDINGS…”