Activating Behavior for Lasting Engagement After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Change in Daily Sedentary Time Accumulated in Bouts Greater Than or Equal to 30 Minutes
研究概览
简要总结
Stroke survivors demonstrate high levels of sedentary behavior, placing them at risk for exacerbation of chronic health conditions. This may lead to recurrent stroke. Subtle cognitive impairments are common after stroke and can lead to difficulty self-monitoring and problem solving to overcome barriers to physical activity. Investigators developed the Activating Behavior for Lasting Engagement (ABLE) intervention to promote activity scheduling, self-monitoring, and problem solving activity over the full day. This study examines the effects of the ABLE intervention on sedentary behavior after stroke.
详细描述
The study advisory committee added a dose-matched, no-intervention delayed baseline to the study protocol following initial documentation of this study protocol on clinicaltrials.gov. The purpose of this delayed baseline design was to assess the baseline stability on the primary and secondary outcomes. The addition of this timepoint resulted in a shift of post-intervention timepoints as follows: Baseline 1 (week 1), Baseline 2 (week 6), Post-intervention (week 11), and Follow-up (week 18). Intervention was delivered between Baseline 2 and Post-intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of ischemic or hemorrhagic stroke
- •≥6 months and ≤24 months post-stroke
- •≥18 years of age
- •ambulatory in the community with or without an assistive device (e.g. walker, cane)
- •self-reported sedentary behavior (≥6 hours/day of sedentary behavior reported using the Sedentary Behavior Questionnaire)
- •reside within 50 miles of Pittsburgh, Pennsylvania
排除标准
- •severe aphasia (Boston Diagnostic Aphasia Examination score ≤1)
- •currently receiving outpatient or home care rehabilitation services (physical therapy, occupational therapy, or speech therapy)
- •current active cancer treatment
- •medical history of neurodegenerative disorder (i.e. dementia, Parkinson's disease, multiple sclerosis, Lou Gehrig's disease (ALS), glioblastoma, myasthenia gravis)
- •current major depressive disorder, psychiatric condition, substance abuse (Patient Health Questionnaire-9, PRIME-MD/MINI)
结局指标
主要结局
Change in Daily Sedentary Time Accumulated in Bouts Greater Than or Equal to 30 Minutes
时间窗: Baseline (Baseline=computed mean of week 1 and week 6) to 11 weeks
Objectively measured sedentary time (ActivPAL)
Change in Daily Number of Sedentary Breaks
时间窗: Baseline (Baseline=computed mean of week 1 and week 6) to 11 weeks
Objectively measured sedentary breaks (ActivPAL)
次要结局
- Change in Daily Number of Sedentary Breaks(Baseline (Baseline=computed mean of week 1 and week 6) to 18 weeks)
- Change in Participation(Baseline (Baseline=computed mean of week 1 and week 6) to 18 weeks)
- Change in Daily Sedentary Time Accumulated in Bouts Greater Than or Equal to 30 Minutes(Baseline (Baseline=computed mean of week 1 and week 6) to 18 weeks)
研究者
Emily Kringle
Occupational Therapist
University of Pittsburgh