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运动性中风预防康复干预试验(SPRITE)——一项随机可行性研究。

Stroke Prevention Rehabilitation Intervention Trial of Exercise (SPRITE) - a randomised feasibility study.

作者信息

Heron Neil, Kee Frank, Mant Jonathan, Reilly Philip M, Cupples Margaret, Tully Mark, Donnelly Michael

机构信息

Department of General Practice and Primary Care, Queen's University, Belfast, UK.

Centre for Public Health Research, Queen's University, Belfast, UK.

出版信息

BMC Cardiovasc Disord. 2017 Dec 12;17(1):290. doi: 10.1186/s12872-017-0717-9.

DOI:10.1186/s12872-017-0717-9
PMID:29233087
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5727948/
Abstract

BACKGROUND

The value of cardiac rehabilitation (CR) after a transient ischaemic attack (TIA) or minor stroke is untested despite these conditions sharing similar pathology and risk factors to coronary heart disease. We aimed to evaluate the feasibility of conducting a trial of an adapted home-based CR programme, 'The Healthy Brain Rehabilitation Manual', for patients following a TIA/minor stroke, participants' views on the intervention and, to identify the behaviour change techniques (BCTs) used.

METHODS

Clinicians were asked to identify patients attending the Ulster Hospital, Belfast within 4 weeks of a first TIA or minor stroke. Those who agreed to participate underwent assessments of physical fitness, cardiovascular risk, quality of life and mental health, before random allocation to: Group (1) standard/usual care; (2) rehabilitation manual or (3) manual plus pedometer. All participants received telephone support at 1 and 4 weeks, reassessment at 6 weeks and an invitation to a focus group exploring views regarding the study. Two trained review authors independently assessed the manual to identify the BCTs used.

RESULTS

Twenty-eight patients were invited to participate, with 15 (10 men, 5 women; 9 TIA, 6 minor stroke; mean age 69 years) consenting and completing the study. Mean time to enrolment from the TIA/stroke was 20.5 days. Participants completed all assessment measures except VO testing, which all declined. The manual and telephone contact were viewed positively, as credible sources of advice. Pedometers were valued highly, particularly for goal-setting. Overall, 36 individual BCTs were used, the commonest being centred around setting goals and planning as well as social support.

CONCLUSION

Recruitment and retention rates suggest that a trial to evaluate the effectiveness of a novel home-based CR programme, implemented within 4 weeks of a first TIA/minor stroke is feasible. The commonest BCTs used within the manual revolve around goals, planning and social support, in keeping with UK national guidelines. The findings from this feasibility work have been used to further refine the next stage of the intervention's development, a pilot study.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT02712385 . This study was registered prospectively on 18/03/2016.

摘要

背景

尽管短暂性脑缺血发作(TIA)或轻度中风与冠心病有相似的病理和危险因素,但心脏康复(CR)在这些疾病后的价值尚未得到验证。我们旨在评估对TIA/轻度中风患者开展一项适应性居家心脏康复计划——《健康大脑康复手册》试验的可行性、参与者对该干预措施的看法,并确定所使用的行为改变技术(BCT)。

方法

要求临床医生识别在贝尔法斯特阿尔斯特医院首次发生TIA或轻度中风后4周内就诊的患者。同意参与的患者在随机分配到以下组之前,接受身体 fitness、心血管风险、生活质量和心理健康的评估:组(1)标准/常规护理;(2)康复手册;或(3)手册加计步器。所有参与者在第1周和第4周接受电话支持,在第6周接受重新评估,并被邀请参加一个焦点小组,探讨对该研究的看法。两名经过培训的综述作者独立评估手册,以确定所使用的BCT。

结果

邀请了28名患者参与,15名(10名男性,5名女性;9名TIA,6名轻度中风;平均年龄69岁)同意并完成了研究。从TIA/中风到入组的平均时间为20.5天。参与者完成了所有评估措施,但VO测试除外,所有这些指标均下降。手册和电话联系被视为积极且可靠的建议来源。计步器受到高度重视,特别是在设定目标方面。总体而言,使用了36种个体BCT,最常见的集中在设定目标、规划以及社会支持方面。

结论

招募和保留率表明,在首次TIA/轻度中风后4周内实施一项评估新型居家心脏康复计划有效性的试验是可行的。手册中使用最频繁的BCT围绕目标、规划和社会支持展开,符合英国国家指南。这项可行性工作的结果已被用于进一步完善干预措施开发的下一阶段——一项试点研究。

试验注册

ClinicalTrials.gov标识符:NCT02712385。本研究于2016年3月18日进行前瞻性注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ba79/5727948/0a3efe98d60d/12872_2017_717_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ba79/5727948/0a3efe98d60d/12872_2017_717_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ba79/5727948/0a3efe98d60d/12872_2017_717_Fig1_HTML.jpg

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