Best John R, Eng Janice J, Davis Jennifer C, Hsiung Robin, Hall Peter A, Middleton Laura E, Graf Peter, Goldsmith Charles H, Liu-Ambrose Teresa
Department of Physical Therapy, University of British Columbia, Vancouver, British Columbia, Canada.
Djavad Mowafaghian Centre for Brain Health, University of British Columbia, Vancouver, British Columbia, Canada.
BMJ Open. 2018 Mar 17;8(3):e021490. doi: 10.1136/bmjopen-2018-021490.
Cerebrovascular disease-such as stroke-is the second most common cause of dementia (ie, vascular dementia). Specifically, a stroke increases one's risk for dementia by a factor of two. Thus, stroke survivors represent a target population in need of intervention strategies to promote cognitive function and prevent dementia. The current standard of care in stroke rehabilitation does not adequately address the significant cognitive consequences of stroke, especially for those who are in the chronic phase (ie, >12 months since an index stroke). Two potential intervention strategies are: (1) exercise training and (2) cognitive and social enrichment activities.
The aim of this proof-of-concept randomised controlled trial is to determine whether a 6-month targeted exercise training programme or a 6-month cognitive and social enrichment programme can efficaciously and efficiently improve cognitive function in older adults with chronic stroke compared with a 6-month stretch and tone programme (ie, control). The primary measurement periods will be baseline, month 6 (postintervention) and month 12 (6-month follow-up). The primary outcome measure will be performance on the Alzheimer's Disease Assessment Scale-Cognitive-Plus (ADAS-Cog-Plus), a global measure of cognitive performance using multidimensional item response theory to summarise scores from the 13-item ADAS-Cog and other standard cognitive assessments. The primary analysis will compare changes in ADAS-Cog-Plus performance from baseline to month 6. Proof-of-concept outcomes relating to intervention feasibility will be analysed descriptively. The economic evaluation will examine the incremental costs and health outcome benefits generated by both interventions versus the control.
Ethical approval has been obtained from the University of British Columbia's Clinical Research Ethics Board (H13-00715, 26 July 2013). Any modifications to the protocol will require a formal amendment to the protocol and approval by the Research Ethics Board. Outcomes of this randomised controlled trial and the statistical code to generate those outcomes will be disseminated through publication in peer-reviewed journals as well as conference presentations.
NCT01916486.
脑血管疾病（如中风）是痴呆症（即血管性痴呆）的第二大常见病因。具体而言，中风会使患痴呆症的风险增加一倍。因此，中风幸存者是需要干预策略以促进认知功能和预防痴呆症的目标人群。目前中风康复的护理标准并未充分解决中风带来的重大认知后果，尤其是对于处于慢性期（即首次中风后超过12个月）的患者。两种潜在的干预策略是：（1）运动训练和（2）认知与社交丰富活动。
这项概念验证随机对照试验的目的是确定，与为期6个月的伸展和放松计划（即对照）相比，为期6个月的针对性运动训练计划或为期6个月的认知与社交丰富计划能否有效且高效地改善患有慢性中风的老年人的认知功能。主要测量期将为基线期、第6个月（干预后）和第12个月（6个月随访）。主要结局指标将是阿尔茨海默病评估量表-认知增强版（ADAS-Cog-Plus）的表现，这是一种使用多维度项目反应理论来汇总13项ADAS-Cog及其他标准认知评估分数的认知表现综合测量方法。主要分析将比较从基线到第6个月ADAS-Cog-Plus表现的变化。将对与干预可行性相关的概念验证结果进行描述性分析。经济评估将考察两种干预措施与对照措施相比产生的增量成本和健康结局效益。
已获得英属哥伦比亚大学临床研究伦理委员会的伦理批准（H13-00715，2013年7月26日）。对方案的任何修改都需要对方案进行正式修订并获得研究伦理委员会的批准。这项随机对照试验的结果以及生成这些结果的统计代码将通过在同行评审期刊上发表以及在会议上展示来传播。
NCT01916486。
