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

Sponsor

Duke University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04664101

Collaborator

Vanderbilt University (Other)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Covid19 Critical Illness High Intensity Interval Training ICU Intensive Care Units Fitness Trackers	Behavioral: REmotely Monitored, Mhealth (REMM) supported High Intensity Interval Training (HIIT) Other: Comparator	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 2, 2022

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: 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.
Other: 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	Other: 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

Arm

Intervention/Treatment

Experimental: 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.

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

Other: 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

Other: Comparator

Outcome Measures

Primary Outcome Measures

Peak oxygen consumption (V02P) at 3 months after hospital discharge [3 months post-discharge]

Secondary Outcome Measures

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 Fried Frailty (includes Hand Grip strength)
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 Montreal Cognitive Assessment (MOCA)
Change in cognition from baseline to 3 months after hospital discharge. [Hospital discharge (baseline), 3 months post-discharge]
Measured by Hayling Sentence Completion
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 after hospital discharge. [Hospital discharge (baseline), 3 months post-discharge]
Measured by Sociodemographic survey
Change in quality of life from baseline to 3 months after hospital discharge. [Hospital discharge (baseline), 3 months post-discharge]
Measured by Employment Survey
Change in quality of life from baseline to 3 months after hospital discharge. [Hospital discharge (baseline), 3 months post-discharge]
Measured by EQ-5D-5L
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
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 Sociodemographic Survey
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 Employment Survey
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 EQ-5D-5L
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

Other Outcome Measures

Change in biomarkers of aging and resilience, and mitochondrial function from baseline to 3 months post-discharge [Hospital discharge (baseline), 3 months post-discharge]
Measured by peripheral blood mononuclear cell (PBMC)
Change in biomarkers of aging and resilience, and mitochondrial function from baseline to 3 months post-discharge [Hospital discharge (baseline), 3 months post-discharge]
Measured by plasma

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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