NCT04664101已完成不适用
REmotely Monitored, Mobile Health-Supported High Intensity Interval Training After COVID-19 Critical Illness (REMM-HIIT-COVID-19)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 4
- 主要终点
- Peak oxygen consumption (V02P) at 3 months after hospital discharge
研究概览
简要总结
REmotely Monitored, Mobile Health-Supported High Intensity Interval Training after COVID-19 critical illness (REMM-HIIT-COVID-19)
详细描述
REmotely Monitored, Mhealth (REMM) supported High Intensity Interval Training (HIIT to improve recovery after Intensive Care Unit (ICU) discharge in patients with COVID-19 (REMM-HIIT-ICU-COVID) will evaluate the feasibility of clinical-, physiological- and patient-centered outcomes associated with a remotely monitored, Mhealth-supported high intensity interval rehabilitation exercise training to improve the functional recovery of survivors who have experienced critical illness with COVID-19 and have been discharged home from the hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Age >= 18 years
- •ICU admission and subsequent discharge for primary diagnosis of COVID-19 respiratory failure or infection requiring intubation and mechanical ventilation for > 48 hours with an ICU length of stay of ≥ 4 days.
- •Ability to ambulate with or without a gait aid prior to hospital discharge
- •Expected hospital discharge directly back to patient's residence (not to a skilled nursing facility, inpatient rehabilitation center, or long-term acute care hospital)
排除标准
- •Not ambulating independently prior to COVID-19 illness (use of a gait aid permitted)
- •Functional impairment resulting in inability to exercise at hospital discharge (including need for home oxygen requirement)
- •Unable or unwilling to follow coaching via mobile-health iPhone interaction
- •Any absolute contraindications to exercise (as outlined in the American Thoracic Society Guidelines for Cardiopulmonary Exercise Testing), including but not limited to:
- •Recent (< 5 days) acute primary cardiac event
- •Unstable Angina
- •Uncontrolled dysrhythmias causing symptoms or hemodynamic compromise
- •Symptomatic aortic stenosis
- •Uncontrolled symptomatic heart failure
- •Acute myocarditis or pericarditis
- •Suspected or known dissecting aneurysm
结局指标
主要结局
Peak oxygen consumption (V02P) at 3 months after hospital discharge
时间窗: 3 months post-discharge
次要结局
- Change in 6 minute walk test distance from baseline to 3 months after hospital discharge(Hospital discharge (baseline), 3 months post-discharge)
- Change in muscle mass from baseline to 3 months after hospital discharge(Hospital discharge (baseline), 3 months post-discharge)
- Cognition at 3 months after hospital discharge(3 months post-discharge)
- Change in cognition from 3 months to 6 months after hospital discharge.(3 months post-discharge, 6 months post-hospital discharge)
- Change in muscle strength from baseline to 3 months after hospital discharge(Hospital discharge (baseline), 3 months post-discharge)
- Change in cognition from baseline to 3 months after hospital discharge.(Hospital discharge (baseline), 3 months post-discharge)
- Change in quality of life from baseline to 3 months after hospital discharge.(Hospital discharge (baseline), 3 months post-discharge)
- Change in quality of life from baseline to 3 months to 6 months after hospital discharge.(3 months post-discharge, 6 months post-hospital discharge)
研究者
研究点 (4)
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