Status:
RECRUITING
REmotely Monitored, Mobile Health Supported Multidomain Rehabilitation Program With High Intensity Interval Training for COVID-19
Lead Sponsor:
Duke University
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Vanderbilt University Medical Center
Conditions:
COVID-19
Critical Illness
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
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-, ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 23 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05218083
Start Date
February 23 2023
End Date
November 1 2026
Last Update
June 8 2025
Active Locations (5)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
University of Kentucky
Lexington, Kentucky, United States, 40536
3
Duke University Health System
Durham, North Carolina, United States, 27710
4
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43201