RETURN: Recovery of Physical Function After Critical Illness In Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Muscle Strength measured by Chair Rise Test
研究概览
简要总结
The proposed study is a prospective, observational study assessing the recovery of muscle and physical function in patients surviving critical illness (n =150) at hospital discharge (baseline) and repeated serially. Patients will be enrolled after life-saving modalities have been weaned near hospital discharge. Patients will participate in testing at baseline, 3-, 6-, 12-, and 24-months after hospital discharge. In a subset of patients (n = 18), muscle biopsies will be performed at baseline and then repeated once at either 12- or 24-months after hospital discharge.
详细描述
The overarching goal of the proposed study is to determine the trajectories of physical recovery and cellular markers involved with the underlying failure to recover muscle after critical illness, while exploring which characteristics are associated with sustained physical disability. This proposal will examine muscle pathophysiology carefully aligned with physical function outcomes in order to longitudinally assess the recovery, or failed recovery, of muscle function in participants after critical illness:
Aim 1: Determine the long-term trajectory of muscle strength, physical function and ADL recovery in ICU survivors. Patients (n = 150) will participate in a battery of tests to determine muscle and physical function aligned with self-reported measures of ADLs and quality of life at hospital discharge, 3-, 6-, 12-, and 24-months post.
Aim 2: Assess cellular changes in skeletal muscle in ICU survivors contributing to long-term physical dysfunction. In a subgroup of patients enrolled in Aim 1, muscle biopsies will be collected at baseline and long-term follow-up to determine oxidative stress, mitochondrial function, and cellular senescence.
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
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •adult patients (≥40 years of age)
- •patients who have survived an ICU admission of at least 72 hours
- •diagnosis of acute lung injury or sepsis are eligible.
排除标准
- •individuals who were not ambulatory prior to ICU admission,
- •not expected to survive at least 6 months,
- •have a new or pre-existing brain infarct, injury, or neurological condition with deficits preventing participation in physical testing,
- •have a pre-existing geriatric syndrome that were confound recovery trajectory
结局指标
主要结局
Muscle Strength measured by Chair Rise Test
时间窗: Baseline and repeated 3-, 6-, 12-, and 24-months after baseline assessment.
Performance on 5x sit to stand test will be the primary outcome measure representing lower extremity muscle strength ; measured as time in seconds to complete 5 repetitive sit-stands.
Functional Capacity
时间窗: Baseline and repeated 3-, 6-, 12-, and 24-months after baseline assessment.
The 6-minute walk test (6MWT), which measures the distance a participant can walk in six minutes and serves as an indicator of cardiopulmonary function, will be used as a primary outcome.
次要结局
- Muscle morphology # 1(Percent change from baseline to 12 months)
- Muscle morphology #2(Percent change from baseline to 12 months)
- Lower-extremity Muscle Power(Baseline and repeated 3-, 6-, 12-, and 24-months after baseline assessment.)
- Muscle Size and Quality measured by Ultrasound(Baseline and repeated 3-, 6-, 12-, and 24-months after baseline assessment.)
- Activities of Daily Living (ADL)(Baseline and repeated 3-, 6-, 12-, and 24-months after baseline assessment.)
- Health Reported Quality of Life(Baseline and repeated 3-, 6-, 12-, and 24-months after baseline assessment.)
- Fatigue(Baseline and repeated 3-, 6-, 12-, and 24-months after baseline assessment.)
- Physical Frailty(Baseline and repeated 3-, 6-, 12-, and 24-months after baseline assessment.)
- Physical Activity(Baseline and repeated 3-, 6-, 12-, and 24-months after baseline assessment.)
- Muscle strength of quadriceps(Baseline and repeated 3-, 6-, 12-, and 24-months after baseline assessment.)
- Grip Strength(Baseline and repeated 3-, 6-, 12-, and 24-months after baseline assessment.)
- Physical function(Baseline and repeated 3-, 6-, 12-, and 24-months after baseline assessment.)
研究者
Kirby Mayer
Associate Professor
University of Kentucky