REmotely Monitored, Mobile Health Supported Multidomain Rehabilitation Program With High Intensity Interval Training for COVID-19
Recruiting now · Not applicable
Conditions studied: COVID-19, Critical Illness, ICU Acquired Weakness, PICS, Cardiorespiratory Fitness
In brief
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.
Key facts
- Study ID
- NCT05218083
- Run by
- Duke University
- People needed
- 120
- Starts
- 2023-02-23
- Expected to finish
- 2027-04-01
- Last updated by the study team
- 2026-05-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)
- University of Kentucky — Lexington, Kentucky, United States (enrolling)
- Duke University Health System — Durham, North Carolina, United States (enrolling)
- The Ohio State University Wexner Medical Center — Columbus, Ohio, United States (enrolling)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.