Rise & Shine: Promoting Sleep Quality in Chronic Stroke With Exercise
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Sleep Efficiency
研究概览
简要总结
health problems, such as heart disease, diabetes, cognitive impairment, and dementia.
After a person suffers a stroke, they often experience difficulties in getting a good night's sleep. Approximately half of stroke survivors have insomnia, or have trouble falling and/or staying asleep. Poor sleep quality among stroke survivors increases the risk of recurrent stroke by 3-fold and the risk of early death by 76%. Hence, stroke survivors need strategies to promote better sleep.
Fortunately, evidence shows that sleep quality can be improved with exercise, even among those who struggle with insomnia. Whether exercise training can improve sleep quality in adults with chronic stroke (i.e., at least 12 months has passed since their stroke) and poor sleep quality is not known. In addition, it is unknown if improved sleep is associated with improved outcomes in those with chronic stroke.
This study will specifically evaluate the effect of twice-weekly targeted exercise training on sleep quality over a 6-month period in persons with chronic stroke and poor sleep quality. This study will also evaluate the effect of exercise on the following outcomes: 1) sleep structure; 2) fatigue; 3) daytime sleepiness; 4) mood; 5) physical function and capacity; 6) thinking abilities; 7) heart health; and 8) quality of life. Finally, this study will examine how changes in sleep quality may be related to changes in these outcomes. Our proposed research is timely as the importance of sleep to recovery, health, and wellbeing post-stroke is increasingly recognized.
详细描述
Approximately half of stroke survivors have insomnia. Poor sleep quality among stroke survivors increases the risk of recurrent stroke by 3-fold and the risk of early death by 76%. Hence, stroke survivors are a target population in need of intervention strategies to promote sleep quality.
Current research and stroke rehabilitation do not address the sleep consequences of stroke - especially for those in the chronic phase (i.e., = or > 12 months since an index stroke). Adults with chronic stroke have lower sleep efficiency compared with sex- and age-matched controls. Poor sleep quality in chronic stroke is associated with depression, impaired physical function, and reduced cognitive function.
How to effectively treat insomnia in adults with chronic stroke is not well established. Intervention studies show exercise improves sleep quality and structure. Whether exercise can improve sleep quality in adults with chronic stroke and poor sleep quality is not established.
Primary Question: In adults with chronic stroke and poor sleep quality, can a 26-week multimodal exercise training program of moderate intensity (EX) improve sleep efficiency, as objectively measured by the actigraphy, compared with a 26-week cognitive and social activities program (CON; active control group)?
Secondary Question: What are additional benefits of EX vs. CON? Compared with CON, we will evaluate the effect of EX on: 1) actigraphy-measured sleep parameters of latency, duration, and wake after sleep onset; 2) sleep architecture by frontal electroencephalography; 3) subjective sleep quality; 4) fatigue; 5) daytime sleepiness; 6) mood; 7) functional capacity; 8) cognitive function; 9) cardiometabolic risk factors; and 10) quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •We will include community-dwelling adults who had an ischemic or hemorrhagic stroke at least one year prior to study enrolment and have poor sleep quality - defined as a sleep efficiency of < or = 85%, with allowance for minor upward deviations on individual nights consistent with known night-to-night variability and instrument accuracy limits, and a PSQI global score of >
- •Individuals must also meet these inclusion criteria: 1) aged 55 years and older; 2) a baseline MMSE score of = or > 22/30 and a MoCA score of = or > 19/30; 3) community-dwelling; 4) able to comply with scheduled assessments, classes, and other trial procedures; 5) read, write, and speak English with acceptable visual and auditory acuity; 6) not to start or stable (i.e., = or > 6 months) on a fixed dose of medication that impacts sleep (i.e., anti-arrhythmics, beta blockers, selective serotonin reuptake inhibitor, etc.) during the 26-week intervention period; 7) able to walk for a minimum of six metres with rest intervals with or without assistive devices; 8) based on interview, have an activity tolerance of 60 minutes with rest intervals; 9) not participating in any regular therapy or progressive exercise (e.g., treadmill or weight-lifting); and 10) able to safely engage in exercise as indicated by the PAR-Q+63 and written confirmation by family or study physicians.
排除标准
- •We will exclude individuals who: 1) are diagnosed with OSA and are not using CPAP or defined as potentially having undiagnosed OSA (AHI > 20) as a result of study screening; 2) have restless leg syndrome; 3) are diagnosed with dementia of any type; 4) are diagnosed with another type of neurodegenerative or neurological condition (e.g., Parkinson's disease); 5) are planning to participate, or already enrolled in, a clinical drug trial or exercise trial concurrent to this study; 6) are at high risk for cardiac complications during exercise and/or unable to self-regulate activity or to understand recommended activity level; 7) have clinically significant peripheral neuropathy or severe musculoskeletal or joint disease that impairs mobility, as determined by his/her physician; or 8) have aphasia as judged by an inability to communicate by phone.
研究组 & 干预措施
Multimodal Exercise Training
The program will consist of moderate intensity, multimodal exercise training; 2x/week; in-person, group-based.
干预措施: Multimodal Exercise (Behavioral)
Cognitive and Social Activities (No Exercise)
The program will consist of cognitive and social activites; 2x/week; in-person, group-based
干预措施: Cognitve and Social Activities (Behavioral)
结局指标
主要结局
Sleep Efficiency
时间窗: Baseline, 13 weeks, 26 weeks
Sleep efficiency as measured by actigraphy over days of wear.
次要结局
- Sleepiness(Baseline, 13 weeks, 26 weeks)
- Mood(Baseline, 13 weeks, 26 weeks)
- NIH Toolbox Cognitive Battery(Baseline, 13 weeks, 26 weeks)
- Quality of life(Baseline, 13 weeks, 26 weeks)
- Sleep Architecture (OPTIONAL)(Baseline, 13 weeks, 26 weeks)
- Functional Capacity(Baseline, 13 weeks, 26 weeks)
- Blood Pressure(Baseline, 13 weeks, 26 weeks)
- Blood Biomarkers (OPTIONAL)(Baseline, 13 weeks, 26 weeks)
- Current Physical Activity (Self-Report)(Baseline, 13 weeks, 26 weeks)
- Balance and Mobility(Baseline, 13 weeks, 26 weeks)
- Activities of Daily Living(Baseline, 26 weeks)
- Arterial Stiffness(Baseline, 13 weeks, 26 weeks)
- Sedentary Behaviour(Baseline, 13 weeks, 26 weeks)
- Sleep latency, duration, and wake after sleep onset(Baseline, 13 weeks, 26 weeks)
- Subjective sleep quality(Baseline, 13 weeks, 26 weeks)
- Fatigue(Baseline, 13 weeks, 26 weeks)
- ADAS-Cog Plus(Baseline, 13 weeks, 26 weeks)
- Executive Functions(Baseline, 13 weeks, 26 weeks)
- Verbal Fluency(Baseline, 13 weeks, 26 weeks)
- Memory(Baseline, 13 weeks, 26 weeks)
- Chronotype(Baseline, 13 weeks, 26 weeks)
研究者
Teresa Liu-Ambrose
Professor
University of British Columbia