REmotely Monitored, Mobile Health Supported Multidomain Rehabilitation Program With High Intensity Interval Training for COVID-19
Duke University
120 participants
Feb 23, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- 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 Criteria17
- 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
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Interventions
REmotely Monitored, Mobile health-supported, High Intensity Interval Training consists of remotely monitored tailored, structured, progressive multidomain physical rehabilitation \& personalized instruction \& coaching. Patients complete 3 structured exercise sessions/week consisting of HIIT, strength, balance, and mobility exercises. Following warmup, patients increase workload at a heart rate corresponding to 95% VO2peak for 1-minute before returning to warm-up speed for 1-minute at a heart rate corresponding to 60% VO2peak. Strength includes functional strengthening exercises for lower extremities \& general resistance exercises for major muscle groups. Balance incorporates static \& dynamic exercises, including progressively narrowing base of support with eyes open or closed, reaching forward \& backward starting within base of support \& progressing to outside base of support. Mobility rehabilitation includes dynamic start/stop while walking and changing direction while walking.
Locations(5)
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NCT05218083