Recovery of Physical Function After Critical Illness In Older Adults
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Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Sepsis, Acute Lung Injury(ALI). Базовые параметры: 18 лет — 99 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
RETURN: Recovery of Physical Function After Critical Illness In Older Adults
Обзор
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.
Подробное описание
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.
Первичные конечные точки
- Muscle Strength measured by Chair Rise Test [Срок оценки: Baseline and repeated 3-, 6-, 12-, and 24-months after baseline assessment.]
- Functional Capacity [Срок оценки: Baseline and repeated 3-, 6-, 12-, and 24-months after baseline assessment.]
Вторичные конечные точки (12)
- Muscle morphology # 1 [Срок оценки: Percent change from baseline to 12 months]
- Muscle morphology #2 [Срок оценки: Percent change from baseline to 12 months]
- Lower-extremity Muscle Power [Срок оценки: Baseline and repeated 3-, 6-, 12-, and 24-months after baseline assessment.]
- Muscle Size and Quality measured by Ultrasound [Срок оценки: Baseline and repeated 3-, 6-, 12-, and 24-months after baseline assessment.]
- Activities of Daily Living (ADL) [Срок оценки: Baseline and repeated 3-, 6-, 12-, and 24-months after baseline assessment.]
- Health Reported Quality of Life [Срок оценки: Baseline and repeated 3-, 6-, 12-, and 24-months after baseline assessment.]
- Fatigue [Срок оценки: Baseline and repeated 3-, 6-, 12-, and 24-months after baseline assessment.]
- Physical Frailty [Срок оценки: Baseline and repeated 3-, 6-, 12-, and 24-months after baseline assessment.]
- Physical Activity [Срок оценки: Baseline and repeated 3-, 6-, 12-, and 24-months after baseline assessment.]
- Muscle strength of quadriceps [Срок оценки: Baseline and repeated 3-, 6-, 12-, and 24-months after baseline assessment.]
- Grip Strength [Срок оценки: Baseline and repeated 3-, 6-, 12-, and 24-months after baseline assessment.]
- Physical function [Срок оценки: Baseline and repeated 3-, 6-, 12-, and 24-months after baseline assessment.]
Критерии участия
Критерии включения
- 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.
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
США · 1 центр
- University of Kentucky, Lexington, Kentucky 40536 — Lexington
Идентификаторы
NCT: NCT07225257 · 106867