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NCT05218083NARecruiting

REmotely Monitored, Mobile Health Supported Multidomain Rehabilitation Program With High Intensity Interval Training for COVID-19

Duke University

Start Date

2/23/2023

Completion Date

4/1/2027

Summary

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.

Detailed Description

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.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Pregnant

Interventions

BEHAVIORAL

REmotely monitored, Mobile health supported Multidomain Rehabilitation Program with High Intensity Interval Training (REMM-HIIT)

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Conditions

COVID-19Critical IllnessICU Acquired WeaknessPICSCardiorespiratory Fitness

Locations

University of Alabama at Birmingham

Birmingham, Alabama 35233

United States

University of Kentucky

Lexington, Kentucky 40536

United States

Duke University Health System

Durham, North Carolina 27710

United States

The Ohio State University Wexner Medical Center

Columbus, Ohio 43201

United States

Vanderbilt University Medical Center

Nashville, Tennessee 37203

United States