Cardiorespiratory Fitness, COVID-19, Critical Illness, ICU Acquired Weakness, PICS
Conditions
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 exercise session.
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-, physiological- and patient-centered outcomes associated with a remotely monitored, mobile health-supported high intensity interval rehabilitation exercise training to improve the functional recovery of survivors who have experienced critical illness with COVID-19 and have been discharged home from the hospital.
Interventions
BEHAVIORALREmotely monitored, Mobile health supported Multidomain Rehabilitation Program with High Intensity Interval Training (REMM-HIIT)
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.
Sponsors
Duke University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Vanderbilt University Medical Center
Ohio State University
University of Kentucky
University of Alabama at Birmingham
Florida Atlantic University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in 6 minute walk distance | Baseline to 3 month follow-up | distance walked in m |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cardiorespiratory fitness | Baseline to 3 month follow-up | VO2P obtained during incremental Step Test |
| Change in physical function measured by Short Physical Performance Battery (SPPB) score. | Baseline to 3 month follow-up | Scores range from 0 (frailty) to 12 (robustness). |
| Change in 30-sec sit to stand score | Baseline to 3 month follow-up | Number of times the patient comes to a full standing position in 30 seconds |
| Change in Fried Frailty Index Score | Baseline to 3 month follow-up | Score ranges from 0 (not frail) to 5 (frail). |
| Change in cognitive ability as measured by the MoCA Test | Baseline to 3 months follow-up | Scores range from 0 to 30 with a lower score indicating more cognitive impairment. |
| Change in muscle mass obtained via MuscleSound | Baseline to 3 month follow-up | Change in IMAT index as measured by MuscleSound |
| Compare EQ-5D-5L Score between intervention and control group | Baseline | Scores range from -0.59 to where 1 is the best possible health state. Negative values represent health states perceived as worse than death, which is equal to 0 |
| Compare Duke Activity Status Index (DASI) Score between intervention and control group | Baseline | DASI scores range from 0 to 58.2, with a higher score indicating higher functional capacity. |
| Compare Lawton Score between intervention and control group | Baseline | Score ranges from 0 (very dependent) to 8 (high function, independent) |
| Compare Hospital Anxiety and Depression Scale (HADS) Score between intervention and control group | Baseline | Scores ranges from 0 to 21 for both anxiety and depression, with a higher score indicating more symptoms of depression or anxiety |
| Compare social determinants of health between intervention and control group | 3 months | Completion of the Accountable Health Communities Health-Related Social Needs Screening Tool. A higher score indicates a higher Health-related social need. |
Countries
United States
Contacts
CONTACTMarjan Cobbaert, MPH
PRINCIPAL_INVESTIGATORPaul Wischmeyer, MD
Duke Clinical Research Institute
Outcome results
None listed