NCT05218083招募中不适用
REmotely Monitored, Mobile Health Supported Multidomain Rehabilitation Program With High Intensity Interval Training for COVID-19
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 10
- 主要终点
- Change in 6 minute walk distance
研究概览
简要总结
Multicenter, prospective, randomized controlled trial providing mobile health supported physical rehabilitation to 120 patients who have been critically ill with COVID-19 and who complete at least one exercise session.
详细描述
REmotely Monitored, Mhealth (REMM) supported High Intensity Interval Training (HIIT) to improve recovery after hospital discharge in patients with COVID-19 will evaluate the feasibility of clinical-, physiological- and patient-centered outcomes associated with a remotely monitored, mobile health-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
- Single (Outcomes Assessor)
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
- •Primary diagnosis of COVID-19 requiring hospital admission
- •Discharged or expected to be discharged directly home from the hospital (not to a skilled nursing facility, inpatient rehabilitation center, or long-term acute care hospital)
- •Able to ambulate with or without a gait aid prior to hospital discharge
- •Age ≥ 18 years
排除标准
- •Hospital discharge > 60 days unless readmitted to hospital in first 30 days, then 60 day window restarts and new exclusion is last hospital discharge > 60 days
- •Not ambulating independently prior to COVID-19 illness (use of a gait aid permitted)
- •Functional impairment resulting in inability to exercise at baseline
- •Inability or unwillingness to comply with the study requirements or unable or unwilling to follow coaching via mobile-health iPhone interaction
- •Any absolute contraindications to exercise, including but not limited to:
- •Recent (< 5 days) acute primary cardiac event
- •Unstable Angina
- •Uncontrolled dysrhythmias causing symptoms or hemodynamic compromise
- •Uncontrolled hypertension over 255 mmHg Systolic or 155 diastolic blood pressure
- •Symptomatic aortic stenosis
- •Uncontrolled symptomatic heart failure
- •Acute myocarditis or pericarditis
- •Suspected or known dissecting aneurysm
- •Any adverse changes during GXT (i.e., persistent oxygen saturation drop below 88% while on prescribed oxygen therapy or significant hypotension such as mean arterial blood pressure < 60 mmHg on 2 consecutive readings within 1 minute)
- •High risk for non-adherence as determined by screening evaluation
- •Any condition, including cognitive impairment, that, in the judgment of the investigator, precludes participation because it could affect subject safety or ability of subject to complete the study
研究组 & 干预措施
Exercise education without personalized sessions or feedback
No Intervention
Patients will receive an exercise handout and iWatch/iPhone. Patients return home to exercise without personalized instruction and coaching.
REmotely Monitored, Mobile health supported Multidomain Rehabilitation Program with HIIT
Experimental
Patients will receive our REmotely monitored, Mobile health supported Multidomain Rehabilitation Program with High Intensity Interval Training Program (REMM-HIIT) with iWatch/iPhone.
干预措施: REmotely monitored, Mobile health supported Multidomain Rehabilitation Program with High Intensity Interval Training (REMM-HIIT) (Behavioral)
结局指标
主要结局
Change in 6 minute walk distance
时间窗: Baseline to 3 month follow-up
distance walked in m
次要结局
- Change in Cardiorespiratory fitness(Baseline to 3 month follow-up)
- Change in muscle mass obtained via MuscleSound(Baseline to 3 month follow-up)
- Compare EQ-5D-5L Score between intervention and control group(6 month visit)
- Change in physical function measured by Short Physical Performance Battery (SPPB) score.(Baseline to 3 month follow-up)
- Change in 30-sec sit to stand score(Baseline to 3 month follow-up)
- Compare social determinants of health between intervention and control group(6 months)
- Change in Fried Frailty Index Score(Baseline to 3 month follow-up)
- Compare Hospital Anxiety and Depression Scale (HADS) Score between intervention and control group(6 months)
- Change in cognitive ability as measured by the MoCA Test(Baseline to 3 months follow-up)
- Compare Duke Activity Status Index (DASI) Score between intervention and control group(6 months)
- Compare Lawton Score between intervention and control group(6 months)
- Compare EQ-5D-5L Score between intervention and control group(Baseline)
- Compare EQ-5D-5L Score between intervention and control group(3 month visit)
- Compare Duke Activity Status Index (DASI) Score between intervention and control group(Baseline)
- Compare Duke Activity Status Index (DASI) Score between intervention and control group(3 months)
- Compare Lawton Score between intervention and control group(Baseline)
- Compare Lawton Score between intervention and control group(3 months)
- Compare Hospital Anxiety and Depression Scale (HADS) Score between intervention and control group(Baseline)
- Compare Hospital Anxiety and Depression Scale (HADS) Score between intervention and control group(3 months)
- Compare social determinants of health between intervention and control group(3 months)
研究者
研究点 (10)
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