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

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

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Vanderbilt University
• Investigators: Principal Investigator: Paul Wischmeyer, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2022
• Primary Completion (Actual): August 1, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: December 10, 2020
• First Submitted That Met QC Criteria: December 10, 2020
• First Posted (Actual): December 11, 2020

Study Record Updates

• Last Update Posted (Actual): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: intensive care unit; Covid19; critical care; ICU; critical illness; high intensity interval training; fitness trackers
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; COVID-19; Critical Illness
• Other Study ID Numbers: Pro00105798

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No