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.
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
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
Parallel
REmotely monitored, Mobile health supported Multidomain Rehabilitation Program with High Intensity Interval Training (REMM-HIIT)
BehavioralREmotely 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.
Change in 6 minute walk distance
distance walked in m
Change in Cardiorespiratory fitness
VO2P obtained during incremental Step Test
Change in physical function measured by Short Physical Performance Battery (SPPB) score.
Scores range from 0 (frailty) to 12 (robustness).
Change in 30-sec sit to stand score
Number of times the patient comes to a full standing position in 30 seconds
Change in Fried Frailty Index Score
Score ranges from 0 (not frail) to 5 (frail).
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Duke University
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Vanderbilt University Medical Center
Collaborator
Ohio State University
Collaborator
University of Kentucky
Collaborator
University of Alabama at Birmingham
Collaborator
Florida Atlantic University
Collaborator
