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

N. Adams, D. Skelton, C. Bailey, D. Howel, Dorothy Coe, Rosy Lampitt, J. Wilkinson, T. Fouweather, L. D. de Jong, S. Gawler, V. Deary, J. Gray, H. Waterman, S. Parry
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引用次数: 3

Abstract

The visually impaired have a higher risk of falling and are likely to avoid activity. To adapt the existing Falls Management Exercise (FaME) programme, which is delivered in the community, for visually impaired older people (VIOP) and to investigate the feasibility of conducting a definitive randomised controlled trial of this adapted intervention. Phase I – consultation with stakeholders to adapt the existing 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 programme for VIOP versus usual care. Phases III and IV – qualitative interviews with VIOP and Postural Stability Instructors regarding their views and experiences of the research process, undertaking the intervention and its acceptability. This was adapted from the group-based FaME programme. A 1-hour exercise programme ran weekly over 12 weeks at the study sites (Newcastle upon Tyne 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. 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. Instructors’ 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 for all participants in both the intervention and control arm. 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 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. Instructors identified issues regarding level of challenge and assistance from a second person. The small sample size and low falls risk of the study sample are study limitations. Although adaptation, recruitment and delivery were successful, the findings (particularly from qualitative research with instructors and participants) 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. Current Controlled Trials ISRCTN16949845. This project was funded by the NIHR Public Health Research programme and will be published in full in Public Health Research; Vol. 7, No. 4. See the NIHR Journals Library website for further project information.
视力受损老年人预防跌倒运动方案:可行性研究
视力受损的人摔倒的风险更高,可能会避免活动。调整现有的社区视力受损老年人(VIOP)跌倒管理练习(FaME)计划,并调查对这一调整干预措施进行最终随机对照试验的可行性。第一阶段-谘询持份者,以调整现有计划。进行了两个焦点小组,每个小组在研究地点有10个VIOP。II期:双中心随机试点试验和对VIOP与常规护理的适应性方案的经济评估。第三和第四阶段:对VIOP和姿势稳定指导员进行定性访谈,了解他们对研究过程的看法和经验,进行干预及其可接受性。这是改编自以团体为基础的FaME计划。在研究地点(泰恩河畔的纽卡斯尔和格拉斯哥),每周进行一小时的锻炼计划,为期12周,由第三部门组织提供。研究人员还建议参与者每周在家锻炼2小时。那些被随机分配到常规活动组的人没有接受任何干预。这些在基线、第12周和第24周完成。使用的主要潜在结果测量是短形式瀑布疗效量表-国际。次要结果评估指标为活动避免、当前活动、平衡/跌倒风险、身体活动、孤独、焦虑和抑郁、工作和社会适应、生活质量和经济成本。参与者的依从性通过回顾出勤记录和自我报告对家庭练习的依从性来评估。教师对课程内容的依从性(保真度)由参加训练课程样本的研究人员进行评估。对干预组和对照组的所有参与者每周进行一次电话调查,收集不良事件。与利益相关者一起制定了一项经过调整的锻炼方案。在试点试验中,筛选了82名来自社区生活VIOP的参与者,68名符合纳入标准,64名随机分组,其中33名分配到干预组,31名分配到常规活动组。总共94%的参与者在第12周提供数据,92%在第24周提供数据。这项研究的依从性很高。研究发现,干预措施对参与者来说既安全又可接受,76%的人参加了9节或更多的课程。每周在家锻炼的平均时间为50分钟。在随访中,很少或没有证据表明试验组之间对跌倒的恐惧、运动、态度或生活质量的结果存在差异。对VIOP参与者的访谈进行专题分析,确定了运动的促进因素和障碍,包括与健康、福祉和生活方式、社会互动、自我认知和实际援助的感知关联。指导员确定了有关挑战水平和第二个人帮助的问题。研究样本的小样本量和低跌倒风险是研究的局限性。虽然适应、招募和交付都是成功的,但研究结果(特别是对指导员和参与者进行的定性研究)表明,低至中度跌倒风险的VIOP可以通过一些调整纳入主流项目。未来的明确试验应考虑适合能力的分级练习,并在主流规定范围内降低风险。可能还会考虑其他结果测量。当前对照试验ISRCTN16949845。该项目由国家卫生研究院公共卫生研究计划资助,将全文发表在《公共卫生研究》上;第七卷,第4期请参阅NIHR期刊图书馆网站了解更多项目信息。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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