Clinical trial NCT04664101: REmotely Monitored, Mobile Health-Supported High Intensity Interval Training After COVID-19 Critical Illness (REMM-HIIT-COVID-19)
Official title: REmotely Monitored, Mobile Health-Supported High Intensity Interval Training After COVID-19 Critical Illness (REMM-HIIT-COVID-19)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Critical Illness
High Intensity Interval Training
ICU
Intensive Care Units
Fitness Trackers
Keywords: critical care
Covid19
ICU
high intensity interval training
intensive care unit
critical illness
fitness trackers
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Vanderbilt University
First posted: 2020-12-11
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Peak oxygen consumption (V02P) at 3 months after hospital discharge
timeFrame: 3 months post-discharge
Secondary outcomes:
measure: Change in 6 minute walk test distance from baseline to 3 months after hospital discharge
timeFrame: Hospital discharge (baseline), 3 months post-discharge
measure: Change in muscle mass from baseline to 3 months after hospital discharge
timeFrame: Hospital discharge (baseline), 3 months post-discharge
measure: Change in muscle strength from baseline to 3 months after hospital discharge
timeFrame: Hospital discharge (baseline), 3 months post-discharge
measure: Change in muscle strength from baseline to 3 months after hospital discharge
timeFrame: Hospital discharge (baseline), 3 months post-discharge
measure: Cognition at 3 months after hospital discharge
timeFrame: 3 months post-discharge
measure: Change in cognition from baseline to 3 months after hospital discharge.
timeFrame: Hospital discharge (baseline), 3 months post-discharge
measure: Change in cognition from baseline to 3 months after hospital discharge.
timeFrame: Hospital discharge (baseline), 3 months post-discharge
measure: Change in cognition from baseline to 3 months after hospital discharge.
timeFrame: Hospital discharge (baseline), 3 months post-discharge
measure: Change in cognition from 3 months to 6 months after hospital discharge.
timeFrame: 3 months post-discharge, 6 months post-hospital discharge
measure: Change in quality of life from baseline to 3 months after hospital discharge.
timeFrame: Hospital discharge (baseline), 3 months post-discharge
measure: Change in quality of life from baseline to 3 months after hospital discharge.
timeFrame: Hospital discharge (baseline), 3 months post-discharge
measure: Change in quality of life from baseline to 3 months after hospital discharge.
timeFrame: Hospital discharge (baseline), 3 months post-discharge
measure: Change in quality of life from baseline to 3 months after hospital discharge.
timeFrame: Hospital discharge (baseline), 3 months post-discharge
measure: Change in quality of life from baseline to 3 months to 6 months after hospital discharge.
timeFrame: 3 months post-discharge, 6 months post-hospital discharge
measure: Change in quality of life from baseline to 3 months to 6 months after hospital discharge.
timeFrame: 3 months post-discharge, 6 months post-hospital discharge
measure: Change in quality of life from baseline to 3 months to 6 months after hospital discharge.
timeFrame: 3 months post-discharge, 6 months post-hospital discharge
measure: Change in quality of life from baseline to 3 months to 6 months after hospital discharge.
timeFrame: 3 months post-discharge, 6 months post-hospital discharge
Other outcomes:
measure: Change in biomarkers of aging and resilience, and mitochondrial function from baseline to 3 months post-discharge
timeFrame: Hospital discharge (baseline), 3 months post-discharge
measure: Change in biomarkers of aging and resilience, and mitochondrial function from baseline to 3 months post-discharge
timeFrame: Hospital discharge (baseline), 3 months post-discharge
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Duke University
name: Paul Wischmeyer, MD
role: PRINCIPAL_INVESTIGATOR
References: