Early Mobilization in Older Adults With Acute Cardiovascular Disease: A Prospective, Multi-centre Stepped Wedge Cluster Randomized Trial
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 主要终点
- Short Form (SF)-36 Physical Component Summary (PCS) score at 1-month post-hospitalization
研究概览
简要总结
The EM-HEART study is a prospective, multi-centre stepped wedge cluster randomized trial to evaluate the effectiveness of a pragmatic early mobilization (EM) program to improve patient-centred and clinical outcomes in older adults with acute CV disease. There will be 256 participants ≥60 years old with acute CV disease enrolled at 6 participating Canadian hospitals. The study will investigate whether EM improves functional status during admission, as compared to usual care, and whether this leads to improved health-related quality of life post-hospitalization. Functional status will be measured with the validated Level of Function Mobility Scale. The primary outcome will be the Short-Form SF-36 physical component scale score at 1-month post-hospitalization. Secondary outcomes include functional status and hospital readmission at 1-month post-hospitalization.
详细描述
The EM-HEART study is a prospective, multi-centre stepped wedge cluster randomized trial to evaluate the effectiveness of a pragmatic EM program to improve patient-centred and clinical outcomes in older adults with acute CV disease. There will be 256 participants ≥60 years old with acute CV disease enrolled at 6 participating Canadian hospitals. The study will investigate whether EM improves functional status during admission, as compared to usual care, and whether this leads to improved health-related quality of life post-hospitalization. Functional status will be measured with the validated Level of Function Mobility Scale. The primary outcome will be the Short-Form SF-36 physical component scale score at 1-month post-hospitalization. Secondary outcomes include functional status and hospital readmission at 1-month post-hospitalization. Nested cohort studies will explore (1) the relationship between EM, sedentary time, and posthospitalization outcomes and (2) the impact of EM on muscle mass loss and inflammation in older adults with acute CV disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥ 60 years
- •no planned cardiac surgery during admission
排除标准
- •projected cardiac ICU stays less than 24 hours
- •patients unable to complete follow-up
结局指标
主要结局
Short Form (SF)-36 Physical Component Summary (PCS) score at 1-month post-hospitalization
时间窗: 1 month post-hospitalization
Health-related quality of life
次要结局
- SF-36 Mental Component Summary score(12 months post-hospitalization)
- SF-36 Physical Component Scale score(12 months post-hospitalization)
- Level of Function Mobility Score(12 months post-hospitalization)
- Hospital readmission(12 months post-hospitalization)
研究者
Michael Goldfarb
Clinician-Investigator
Lady Davis Institute