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

Duke University

Status: Completed

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

Treatments: Behavioral: REmotely Monitored, Mhealth (REMM) supported High Intensity Interval Training (HIIT); Other: Comparator

Study type: Interventional

Funder types: Other

Identifiers

NCT04664101

Pro00105798

Details and patient eligibility

About

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

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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13 participants in 2 patient groups

REmotely Monitored, Mhealth (REMM) supported High Intensity Interval Training (HIIT)

Experimental group

Description:

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.

Treatment:

Behavioral: REmotely Monitored, Mhealth (REMM) supported High Intensity Interval Training (HIIT)

Comparator

Other group

Description:

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

Treatment:

Other: Comparator