Sarcopenia in Patients During the Acute Phase of Ischemic Stroke: Multimodal Assessment and Three-Month Functional Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Change from Baseline in Barthel Index for Activities of Daily Living at 14 days
研究概览
简要总结
The objective of this observational study is to determine the prevalence of sarcopenia in patients aged 50 years and older with acute ischemic stroke, to characterize its trajectory during the acute phase using instrumental verification and functional-cognitive assessments, and to evaluate its impact on functional outcome at three months. The main research question is:
Is the presence of sarcopenia at admission associated with less favorable stroke outcomes, including higher rates of complications and mortality?
Participants receiving standard medical care for acute ischemic stroke will undergo extended functional assessment for sarcopenia, and a subset will additionally undergo cognitive evaluation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 50 years and older
- •Acute ischemic stroke confirmed by CT or MRI
- •Admission within the first 72 hours
- •Written informed consent and availability of a contact telephone number for follow-up
排除标准
- •TIA without a visible lesion on neuroimaging; bilateral hemiparesis
- •Amputations or severe contractures that preclude anthropometric assessment
- •Active cancer at stage IV or life expectancy of less than 3 months
- •Neuromuscular diseases; chronic use of systemic glucocorticoids for more than 3 months
- •Pregnancy; refusal to participate
- •Discontinuation criteria (drop-out)
- •Discharge or death within the first 7 days
- •Withdrawal of consent
- •Transfer to another facility resulting in loss of contact
结局指标
主要结局
Change from Baseline in Barthel Index for Activities of Daily Living at 14 days
时间窗: Baseline and 14 days
Lower scores indicate increasing disability and a greater need for skilled care. Min - 0 ( \< 20 - totally dependent), max - 100 ( \> 80 - independent).
Change from Baseline in Modified Rankin scale at 90 days
时间窗: Baseline and 90 days
Min - 0 (no disability), max - 6 (dead). A score of 0 is no disability, 5 is disability requiring constant care for all needs; 6 is death.
次要结局
- Number of Participants with sarcopenia(Baseline)
- Change from Baseline in arm muscle mass at 14 and 28 days.(Baseline, 14 and 28 days)
- Change from Baseline in calf circumference at 14 and 28 days(Baseline, 14 and 28 days)
- Change from Baseline in handgrip strength at 14 and 28 days.(Baseline, 14 and 28 days.)
- Correlations between anthropometric measures and ultrasound/CT parameters(Baseline, 14, 28, and 90 days)
- Change from Baseline in National Institutes of Health Stroke Scale (NIHSS) at 24 hours, 7 and 14 days.(Baseline, 24 hours, 7 and 14 days.)
- Change from Baseline in Rivermead Mobility Index at 14 and 28 days.(Baseline, 14 and 28 days.)
- Mortality at 14 and 90 days(14 and 90 days)
- Hospital length of stay(Up to 28 days)
- Intensive care unit length of stay(Up to 28 days)
- Number of Participants with recurrent events within 90 days(From baseline to 90 days)