REmotely Monitored, Mobile Health Supported Multidomain Rehabilitation Program With High Intensit… (NCT05218083) | Clinical Trial Compass
RecruitingNot Applicable
REmotely Monitored, Mobile Health Supported Multidomain Rehabilitation Program With High Intensity Interval Training for COVID-19
United States120 participantsStarted 2023-02-23
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…