REmotely Monitored, Mobile Health-Supported High Intensity Interval Training After COVID-19 Critical Illness (REMM-HIIT-COVID-19)

Study Overview
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Brief Summary
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REmotely Monitored, Mobile Health-Supported High Intensity Interval Training after COVID-19 critical illness (REMM-HIIT-COVID-19)

Detailed Description
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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.

Official Title
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REmotely Monitored, Mobile Health-Supported High Intensity Interval Training After COVID-19 Critical Illness (REMM-HIIT-COVID-19)

Conditions
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Covid19, Critical Illness, High Intensity Interval Training, ICU, Intensive Care Units, Fitness Trackers

Intervention / Treatment
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* Behavioral: REmotely Monitored, Mhealth (REMM) supported High Intensity Interval Training (HIIT)
* Other: Comparator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >= 18 years 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. Ability to ambulate with or without a gait aid prior to hospital discharge 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: 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: Recent (< 5 days) acute primary cardiac event Unstable Angina Uncontrolled dysrhythmias causing symptoms or hemodynamic compromise Symptomatic aortic stenosis Uncontrolled symptomatic heart failure Acute myocarditis or pericarditis Suspected or known dissecting aneurysm

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: REmotely Monitored, Mhealth (REMM) supported High Intensity Interval Training (HIIT)<br>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. | Behavioral: REmotely Monitored, Mhealth (REMM) supported High Intensity Interval Training (HIIT)<br>* 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.<br>|
| Other: Comparator<br>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 | Other: Comparator<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak oxygen consumption (V02P) at 3 months after hospital discharge |  | 3 months post-discharge | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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critical care, Covid19, ICU, high intensity interval training, intensive care unit, critical illness, fitness trackers