Department of General Practice and Primary Health Care, University of Auckland, Auckland, New Zealand.
Department of Statistics, University of Auckland, Auckland, New Zealand.
Lancet Healthy Longev. 2022 Aug;3(8):e519-e530. doi: 10.1016/S2666-7568(22)00124-6.
BACKGROUND: The increasing prevalence of frailty with age is becoming a public health priority in countries with ageing populations. Pre-frailty presents a window of opportunity to prevent the development of frailty in community-dwelling older adults. This study aimed to examine the effectiveness of a complex intervention that combined a nutrition-based intervention and a physical activity intervention, along with the effectiveness of each intervention individually, to reduce physical frailty in pre-frail older adults over 2 years. METHODS: In this single-blind, 2 x 2 factorial, randomised, controlled trial, we recruited pre-frail community-dwelling older adults in Aotearoa New Zealand via mail through general medical practices. To be eligible, participants had to be pre-frail according to self-reported FRAIL scores of 1 or 2, aged 75 years or older (or 60 years or older for Māori and Pacific Peoples), not terminally ill or with advanced dementia as judged by a general practitioner, able to stand, medically safe to participate in low-intensity exercise, and able to use kitchen utensils safely. Participants were randomly allocated to receive an 8-week Senior Chef programme (SC group), a 10-week Steady As You Go programme (SAYGO group), a 10-week combined SC and SAYGO intervention (combined group), or a 10-week social programme (control group), using computer-generated block randomisation administered through an electronic data capture system by local study coordinators. Assessors were masked to group allocation for all assessments. SC is a group-based nutrition education and cooking class programme (3 h weekly), SAYGO is a group-based strength and balance exercise programme (1 h weekly), and the social control programme was a seated, group socialising activity (once a week). Masked assessors ascertained Fried frailty scores at baseline, end of intervention, and at 6, 12, and 24 months after the programme. The primary outcome was change in Fried frailty score at 2 years. Intention-to-treat analyses were completed for all randomised participants, and all participants who had a high (≥75%) adherence were analysed per protocol. This study is registered at ANZCTR, ACTRN12614000827639. FINDINGS: Between May 12, 2016 and April 9, 2018, we assessed 2678 older adults for eligibility, of whom 468 (17%) consented and completed baseline assessment, with a mean age of 80·3 years (SD 5·1) and a mean Fried score of 1·9 (1·2); 59% were women. We randomly allocated these participants into the four groups: 117 in the SC group, 118 in the SAYGO group, 118 in the combined group, and 115 in the control group; 318 participants attended the 24-month follow-up: 89 in the SC group, 78 in the SAYGO group, 73 in the combined group, and 78 in the control group. At the 24-month follow-up, there were no differences in mean Fried scores between the intervention groups and the control group. No adverse events were reported. INTERPRETATION: The study did not find that the combined SC and SAYGO programme was effective in reducing frailty in pre-frail older adults. Although some short-term benefits were observed in each individual programme, there was no clear evidence of long-term impact. Further research is needed to evaluate combinations of group-based programmes for community-dwelling older adults to optimise their physical function. FUNDING: Health Research Council New Zealand and Ageing Well Challenge (Ministry of Business Innovation and Employment).
背景:随着人口老龄化,衰弱症的患病率不断上升,这在老龄化国家已成为公共卫生重点。衰弱前期为预防社区居住的老年人发生衰弱提供了机会。本研究旨在探讨一种综合干预措施的有效性,该措施结合了营养干预和身体活动干预,以及单独干预的有效性,以减少衰弱前期老年人在 2 年内的身体衰弱。
方法:这是一项单盲、2×2 析因、随机对照试验,我们通过普通医疗实践通过邮件向新西兰奥特罗亚的社区居住的衰弱前期老年人招募参与者。符合条件的参与者必须根据自我报告的 FRAIL 评分(1 或 2)为衰弱前期,年龄在 75 岁以上(或毛利人和太平洋岛民为 60 岁以上),不是绝症或晚期痴呆,由普通医生判断,能够站立,医学上安全地参加低强度运动,并且能够安全使用厨房用具。参与者被随机分配接受 8 周的高级厨师计划(SC 组)、10 周的稳步前进计划(SAYGO 组)、10 周的 SC 和 SAYGO 联合干预(联合组)或 10 周的社会计划(对照组),使用计算机生成的分组随机化通过当地研究协调员管理的电子数据捕获系统进行。评估人员对所有评估均进行了分组分配。SC 是一项基于群体的营养教育和烹饪课计划(每周 3 小时),SAYGO 是一项基于群体的力量和平衡运动计划(每周 1 小时),社会控制计划是一项坐式、群体社交活动(每周一次)。蒙面评估人员在基线、干预结束时以及计划后 6、12 和 24 个月确定 Fried 衰弱评分。主要结局是 2 年后 Fried 衰弱评分的变化。所有随机参与者均进行意向治疗分析,所有高(≥75%)依从性的参与者均进行方案分析。该研究在 ANZCTR 注册,ACTRN12614000827639。
结果:2016 年 5 月 12 日至 2018 年 4 月 9 日,我们评估了 2678 名老年人的资格,其中 468 名(17%)同意并完成了基线评估,平均年龄为 80.3 岁(标准差 5.1),平均 Fried 评分为 1.9(1.2);59%为女性。我们将这些参与者随机分配到四个组:SC 组 117 人,SAYGO 组 118 人,联合组 118 人,对照组 115 人;318 名参与者参加了 24 个月的随访:SC 组 89 人,SAYGO 组 78 人,联合组 73 人,对照组 78 人。在 24 个月的随访中,干预组与对照组之间的平均 Fried 评分没有差异。没有报告不良事件。
解释:该研究并未发现 SC 和 SAYGO 联合计划可有效减轻衰弱前期老年人的衰弱程度。尽管每个单独的方案都观察到了一些短期效益,但没有明确的长期影响证据。需要进一步研究以评估针对社区居住老年人的群体计划组合,以优化他们的身体功能。
资金:新西兰健康研究委员会和衰老挑战(商业创新和就业部)。
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