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| Name | Class |
|---|---|
| Vanderbilt University | OTHER |
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REmotely Monitored, Mobile Health-Supported High Intensity Interval Training after COVID-19 critical illness (REMM-HIIT-COVID-19)
REmotely Monitored, Mhealth (REMM) supported High Intensity Interval Training (HIIT to improve recovery after Intensive Care Unit (ICU) discharge in patients with COVID-19 (REMM-HIIT-ICU-COVID) will evaluate the feasibility of clinical-, physiological- and patient-centered outcomes associated with a remotely monitored, Mhealth-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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REmotely Monitored, Mhealth (REMM) supported High Intensity Interval Training (HIIT) | Experimental | REmotely Monitored, Mhealth (REMM) supported High Intensity Interval Training (HIIT) The intervention consists of high intensity interval training, consisting of a 30-minute exercise session that includes 10 x 1-minute intervals of high intensity 3x/week (e.g., Monday, Wednesday, Friday) and supplemented with 2 sessions per week of strength, balance, and mobility exercises (e.g., Tuesday, Thursday). Exercise will be supported by an activity tracker, which will allow study personnel to track patient heart rates during exercise on a daily basis, allowing them to provide individualized feedback and coaching. |
|
| Comparator | Other | Patients randomized to the control arm will receive the same technology platform and education on exercise options, including HIIT, but will return home to exercise as they see fit without personalized instruction and coaching. They will be remotely monitored, but will not receive feedback unless any adverse events are noted |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REmotely Monitored, Mhealth (REMM) supported High Intensity Interval Training (HIIT) | Behavioral | REmotely Monitored, Mhealth (REMM) supported High Intensity Interval Training (HIIT) The intervention consists of high intensity interval training, consisting of a 30-minute exercise session that includes 10 x 1-minute intervals of high intensity 3x/week (e.g., Monday, Wednesday, Friday) and supplemented with 2 sessions per week of strength, balance, and mobility exercises (e.g., Tuesday, Thursday). Exercise will be supported by an activity tracker, which will allow study personnel to track patient heart rates during exercise on a daily basis, allowing them to provide individualized feedback and coaching. |
| Measure | Description | Time Frame |
|---|---|---|
| Peak oxygen consumption (V02P) at 3 months after hospital discharge | 3 months post-discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 6 minute walk test distance from baseline to 3 months after hospital discharge | distance walked in 6 minutes | Hospital discharge (baseline), 3 months post-discharge |
| Change in muscle mass from baseline to 3 months after hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Change in biomarkers of aging and resilience, and mitochondrial function from baseline to 3 months post-discharge | Measured by peripheral blood mononuclear cell (PBMC) | Hospital discharge (baseline), 3 months post-discharge |
| Change in biomarkers of aging and resilience, and mitochondrial function from baseline to 3 months post-discharge |
Inclusion Criteria:
Exclusion Criteria:
Not ambulating independently prior to COVID-19 illness (use of a gait aid permitted)
Functional impairment resulting in inability to exercise at hospital discharge (including need for home oxygen requirement)
Unable or unwilling to follow coaching via mobile-health iPhone interaction
Any absolute contraindications to exercise (as outlined in the American Thoracic Society Guidelines for Cardiopulmonary Exercise Testing), including but not limited to:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Wischmeyer, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States | ||
| Vanderbilt University |
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|
| Comparator | Other | Patients randomized to the control arm will receive the same technology platform and education on exercise options, including HIIT, but will return home to exercise as they see fit without personalized instruction and coaching. They will be remotely monitored, but will not receive feedback unless any adverse events are noted |
|
Measured by muscle sound
| Hospital discharge (baseline), 3 months post-discharge |
| Change in muscle strength from baseline to 3 months after hospital discharge | Measured by Fried Frailty (includes Hand Grip strength) | Hospital discharge (baseline), 3 months post-discharge |
| Change in muscle strength from baseline to 3 months after hospital discharge | Measured by quadriceps strength (Quadricep muscle dynamometry) | Hospital discharge (baseline), 3 months post-discharge |
| Cognition at 3 months after hospital discharge | Measured by Repeatable Battery for Assessment of Neuropsychological Status (RBANS) | 3 months post-discharge |
| Change in cognition from baseline to 3 months after hospital discharge. | Measured by Montreal Cognitive Assessment (MOCA) | Hospital discharge (baseline), 3 months post-discharge |
| Change in cognition from baseline to 3 months after hospital discharge. | Measured by Hayling Sentence Completion | Hospital discharge (baseline), 3 months post-discharge |
| Change in cognition from baseline to 3 months after hospital discharge. | Measured by PROMIS Cognitive function | Hospital discharge (baseline), 3 months post-discharge |
| Change in cognition from 3 months to 6 months after hospital discharge. | Measured by PROMIS Cognitive function | 3 months post-discharge, 6 months post-hospital discharge |
| Change in quality of life from baseline to 3 months after hospital discharge. | Measured by Sociodemographic survey | Hospital discharge (baseline), 3 months post-discharge |
| Change in quality of life from baseline to 3 months after hospital discharge. | Measured by Employment Survey | Hospital discharge (baseline), 3 months post-discharge |
| Change in quality of life from baseline to 3 months after hospital discharge. | Measured by EQ-5D-5L | Hospital discharge (baseline), 3 months post-discharge |
| Change in quality of life from baseline to 3 months after hospital discharge. | Measured by Katz ADL/ Lawton IADL | Hospital discharge (baseline), 3 months post-discharge |
| Change in quality of life from baseline to 3 months to 6 months after hospital discharge. | Measured by Sociodemographic Survey | 3 months post-discharge, 6 months post-hospital discharge |
| Change in quality of life from baseline to 3 months to 6 months after hospital discharge. | Measured by Employment Survey | 3 months post-discharge, 6 months post-hospital discharge |
| Change in quality of life from baseline to 3 months to 6 months after hospital discharge. | Measured by EQ-5D-5L | 3 months post-discharge, 6 months post-hospital discharge |
| Change in quality of life from baseline to 3 months to 6 months after hospital discharge. | Measured by Katz ADL/ Lawton IADL | 3 months post-discharge, 6 months post-hospital discharge |
Measured by plasma |
| Hospital discharge (baseline), 3 months post-discharge |
| Nashville |
| Tennessee |
| 37232 |
| United States |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D017216 | Telemedicine |
| ID | Term |
|---|---|
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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