Covid19 Clinical Trial
— REMMHIIT-COVIDOfficial title:
REmotely Monitored, Mobile Health-Supported High Intensity Interval Training After COVID-19 Critical Illness (REMM-HIIT-COVID-19)
Verified date | January 2024 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
REmotely Monitored, Mobile Health-Supported High Intensity Interval Training after COVID-19 critical illness (REMM-HIIT-COVID-19)
Status | Completed |
Enrollment | 13 |
Est. completion date | December 1, 2023 |
Est. primary completion date | August 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Age >= 18 years 2. ICU admission and subsequent discharge for primary diagnosis of COVID-19 respiratory failure or infection requiring intubation and mechanical ventilation for > 48 hours with an ICU length of stay of = 4 days. 3. Ability to ambulate with or without a gait aid prior to hospital discharge 4. Expected hospital discharge directly back to patient's residence (not to a skilled nursing facility, inpatient rehabilitation center, or long-term acute care hospital) Exclusion Criteria: 1. Not ambulating independently prior to COVID-19 illness (use of a gait aid permitted) 2. Functional impairment resulting in inability to exercise at hospital discharge (including need for home oxygen requirement) 3. Unable or unwilling to follow coaching via mobile-health iPhone interaction 4. Any absolute contraindications to exercise (as outlined in the American Thoracic Society Guidelines for Cardiopulmonary Exercise Testing), including but not limited to: 1. Recent (< 5 days) acute primary cardiac event 2. Unstable Angina 3. Uncontrolled dysrhythmias causing symptoms or hemodynamic compromise 4. Symptomatic aortic stenosis 5. Uncontrolled symptomatic heart failure 6. Acute myocarditis or pericarditis 7. Suspected or known dissecting aneurysm |
Country | Name | City | State |
---|---|---|---|
United States | Duke University Medical Center | Durham | North Carolina |
United States | Vanderbilt University | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Duke University | Vanderbilt University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | |
Other | Change in biomarkers of aging and resilience, and mitochondrial function from baseline to 3 months post-discharge | Measured by plasma | Hospital discharge (baseline), 3 months post-discharge | |
Primary | Peak oxygen consumption (V02P) at 3 months after hospital discharge | 3 months post-discharge | ||
Secondary | 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 | |
Secondary | Change in muscle mass from baseline to 3 months after hospital discharge | Measured by muscle sound | Hospital discharge (baseline), 3 months post-discharge | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Cognition at 3 months after hospital discharge | Measured by Repeatable Battery for Assessment of Neuropsychological Status (RBANS) | 3 months post-discharge | |
Secondary | Change in cognition from baseline to 3 months after hospital discharge. | Measured by Montreal Cognitive Assessment (MOCA) | Hospital discharge (baseline), 3 months post-discharge | |
Secondary | Change in cognition from baseline to 3 months after hospital discharge. | Measured by Hayling Sentence Completion | Hospital discharge (baseline), 3 months post-discharge | |
Secondary | Change in cognition from baseline to 3 months after hospital discharge. | Measured by PROMIS Cognitive function | Hospital discharge (baseline), 3 months post-discharge | |
Secondary | 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 | |
Secondary | Change in quality of life from baseline to 3 months after hospital discharge. | Measured by Sociodemographic survey | Hospital discharge (baseline), 3 months post-discharge | |
Secondary | Change in quality of life from baseline to 3 months after hospital discharge. | Measured by Employment Survey | Hospital discharge (baseline), 3 months post-discharge | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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