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

Not Applicable

Completed

• Conditions: Covid19; Critical Illness; Intensive Care Units; Fitness Trackers; ICU; High Intensity Interval Training
• Interventions: Behavioral: REmotely Monitored, Mhealth (REMM) supported High Intensity Interval Training (HIIT); Other: Comparator

• Registration Number: NCT04664101
• Lead Sponsor: Duke University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-12-10
• Study First Submitted QC: 2020-12-10
• Study First Posted: 2020-12-11
• Study Start: 2022-03-02
• Primary Completion: 2023-08-01
• Study Completion: 2023-12-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-17
• Last Update Posted: 2024-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
REmotely Monitored, Mhealth (REMM) supported High Intensity Interval Training (HIIT)	REmotely Monitored, Mhealth (REMM) supported High Intensity Interval Training (HIIT)	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	Comparator	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

Primary Outcome Measures

Name	Time	Method
Peak oxygen consumption (V02P) at 3 months after hospital discharge	3 months post-discharge

Secondary Outcome Measures

Name	Time	Method
Change in 6 minute walk test distance from baseline to 3 months after hospital discharge	Hospital discharge (baseline), 3 months post-discharge	distance walked in 6 minutes
Change in muscle mass from baseline to 3 months after hospital discharge	Hospital discharge (baseline), 3 months post-discharge	Measured by muscle sound
Change in muscle strength from baseline to 3 months after hospital discharge	Hospital discharge (baseline), 3 months post-discharge	Measured by quadriceps strength (Quadricep muscle dynamometry)
Cognition at 3 months after hospital discharge	3 months post-discharge	Measured by Repeatable Battery for Assessment of Neuropsychological Status (RBANS)
Change in cognition from baseline to 3 months after hospital discharge.	Hospital discharge (baseline), 3 months post-discharge	Measured by PROMIS Cognitive function
Change in cognition from 3 months to 6 months after hospital discharge.	3 months post-discharge, 6 months post-hospital discharge	Measured by PROMIS Cognitive function
Change in quality of life from baseline to 3 months to 6 months after hospital discharge.	3 months post-discharge, 6 months post-hospital discharge	Measured by Katz ADL/ Lawton IADL
Change in quality of life from baseline to 3 months after hospital discharge.	Hospital discharge (baseline), 3 months post-discharge	Measured by Katz ADL/ Lawton IADL

Trial Locations

Locations (2)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States