BACKGROUND We tested the feasibility of delivering and evaluating a complex therapy intervention which aimed to promote activity and independence for people with early dementia (PrAISED). Feasibility questions were on: recruitment, randomisation, intervention delivery, adherence and withdrawals, level of supervision required, adverse events, data collection and sample size assumptions. METHODS We conducted a three-arm, multi-site, single-blind, randomised controlled feasibility trial. Eligibility criteria were aged 65 years or older, diagnosed mild dementia or mild cognitive impairment, able to walk without human help, and communicate in English, no co-morbidities that prevented participation in cognitive assessment and capacity to give consent. Participants were recruited from Memory Assessment Service clinics and the 'Join Dementia Research' register. Patient participants were randomised 1:1:1 to a high intensity supervision PrAISED intervention, moderate intensity supervision PrAISED intervention or brief falls prevention assessment and advice (control). The PrAISED intervention aimed for participants to complete three hours of PrAISED exercises a week for 12 months. It included individualised activity and exercise plans and supervised exercises with regular re-assessment and progression, and was delivered by occupational therapists, physiotherapists and rehabilitation support workers. Primary efficacy outcome was the Disability Assessment for Dementia (DAD), measured after 12 months. Secondary outcomes included physical activity, quality of life, mood, cognition, strength, balance, rate of falls, frailty and carer strain. Falls and activity were ascertained by monthly diary. RESULTS Between September 2016 and March 2017 we recruited 60 patient participants and 54 carer participants from two sites. Forty-nine patient participants completed a follow-up interview. Feasibility outcomes were mostly satisfactory, including recruitment and retention, intervention delivery and data completeness for most scales used. We could not maintain blinding of researchers at follow-up and experienced difficulties collecting data using some questionnaires and devices. Participants only completed a mean 77 (moderate supervision) and 71 (high supervision) minutes per week of PrAISED exercises over 12 months. We recorded 19 adverse events, none serious and related to the intervention. CONCLUSION We conclude that with some adjustments to the trial protocol, it is feasible to deliver the PrAISED intervention and conduct a trial. TRIAL REGISTRATION ClinicalTrials.gov: NCT02874300 (first posted 22nd August 2016), ISRCTN: 10550694 (date assigned 31st August 2016).

中文翻译：

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促进早期痴呆症的活动，独立性和稳定性（PrAISED）：一项多地点，随机对照，可行性试验。

背景技术我们测试了提供和评估复杂治疗干预措施的可行性，该干预措施旨在促进早期痴呆症患者的活动和独立性（PrAISED）。可行性问题包括：招募，随机分配，干预措施的提供，依从性和退出，所需的监督水平，不良事件，数据收集和样本量假设。方法我们进行了三臂，多站点，单盲，随机对照的可行性试验。入选标准为65岁或65岁以上，被诊断为轻度痴呆或轻度认知障碍，能够在没有人工帮助的情况下行走，能够用英语交流，没有合并症妨碍参加认知评估和表达同意的能力。参与者是从记忆评估服务诊所招募的，加入痴呆症研究中心的注册处。患者参加者按1：1：1的比例随机接受高强度监护PrAISED干预，中强度监护PrAISED干预或短暂跌倒预防评估和建议（对照）。PrAISED干预旨在让参与者每周完成三个小时的PrAISED练习，持续12个月。它包括个性化的活动和锻炼计划以及受监督的锻炼，并定期进行重新评估和进展，并且由职业治疗师，物理治疗师和康复支持工作者提供。主要疗效结果是痴呆症残疾评估（DAD），在12个月后进行测量。次要结果包括体育锻炼，生活质量，情绪，认知，力量，平衡，跌倒率，虚弱和照顾者紧张。通过每月日记确定跌倒和活动。结果2016年9月至2017年3月，我们从两个地点招募了60名患者参与者和54名护理人员参与者。四十九名患者参加者完成了随访。可行性结果大部分令人满意，包括在大多数使用的量表上的招募和保留，干预措施交付和数据完整性。我们不能使研究人员对后续工作保持盲目性，也无法在使用一些问卷和设备收集数据时遇到困难。参与者在12个月内，每周仅平均完成77次（中等监督）和71次（高级监督）的PrAISED练习。我们记录了19例不良事件，其中没有严重的事件与干预有关。结论我们得出结论，对试验方案进行了一些调整，进行PrAISED干预并进行试验是可行的。试验注册ClinicalTrials.gov：NCT02874300（2016年8月22日首次发布），ISRCTN：10550694（日期为2016年8月31日分配）。