search
Back to results

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

Primary Purpose

Covid19, Critical Illness, High Intensity Interval Training

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
REmotely Monitored, Mhealth (REMM) supported High Intensity Interval Training (HIIT)
Comparator
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring critical care, Covid19, ICU, high intensity interval training, intensive care unit, critical illness, fitness trackers

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Duke University Medical Center
  • Vanderbilt University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

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

Comparator

Arm 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.

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

Outcomes

Primary Outcome Measures

Peak oxygen consumption (V02P) at 3 months after hospital discharge

Secondary Outcome Measures

Change in 6 minute walk test distance from baseline to 3 months after hospital discharge
distance walked in 6 minutes
Change in muscle mass from baseline to 3 months after hospital discharge
Measured by muscle sound
Change in muscle strength from baseline to 3 months after hospital discharge
Measured by Fried Frailty (includes Hand Grip strength)
Change in muscle strength from baseline to 3 months after hospital discharge
Measured by quadriceps strength (Quadricep muscle dynamometry)
Cognition at 3 months after hospital discharge
Measured by Repeatable Battery for Assessment of Neuropsychological Status (RBANS)
Change in cognition from baseline to 3 months after hospital discharge.
Measured by Montreal Cognitive Assessment (MOCA)
Change in cognition from baseline to 3 months after hospital discharge.
Measured by Hayling Sentence Completion
Change in cognition from baseline to 3 months after hospital discharge.
Measured by PROMIS Cognitive function
Change in cognition from 3 months to 6 months after hospital discharge.
Measured by PROMIS Cognitive function
Change in quality of life from baseline to 3 months after hospital discharge.
Measured by Sociodemographic survey
Change in quality of life from baseline to 3 months after hospital discharge.
Measured by Employment Survey
Change in quality of life from baseline to 3 months after hospital discharge.
Measured by EQ-5D-5L
Change in quality of life from baseline to 3 months after hospital discharge.
Measured by Katz ADL/ Lawton IADL
Change in quality of life from baseline to 3 months to 6 months after hospital discharge.
Measured by Sociodemographic Survey
Change in quality of life from baseline to 3 months to 6 months after hospital discharge.
Measured by Employment Survey
Change in quality of life from baseline to 3 months to 6 months after hospital discharge.
Measured by EQ-5D-5L
Change in quality of life from baseline to 3 months to 6 months after hospital discharge.
Measured by Katz ADL/ Lawton IADL

Full Information

First Posted
December 10, 2020
Last Updated
August 18, 2023
Sponsor
Duke University
Collaborators
Vanderbilt University
search

1. Study Identification

Unique Protocol Identification Number
NCT04664101
Brief Title
REmotely Monitored, Mobile Health-Supported High Intensity Interval Training After COVID-19 Critical Illness (REMM-HIIT-COVID-19)
Acronym
REMMHIIT-COVID
Official Title
REmotely Monitored, Mobile Health-Supported High Intensity Interval Training After COVID-19 Critical Illness (REMM-HIIT-COVID-19)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 2, 2022 (Actual)
Primary Completion Date
August 1, 2023 (Actual)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Vanderbilt University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
REmotely Monitored, Mhealth (REMM) supported High Intensity Interval Training (HIIT)
Arm Type
Experimental
Arm 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.
Arm Title
Comparator
Arm Type
Other
Arm 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
Intervention Type
Behavioral
Intervention Name(s)
REmotely Monitored, Mhealth (REMM) supported High Intensity Interval Training (HIIT)
Intervention 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.
Intervention Type
Other
Intervention Name(s)
Comparator
Intervention 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
Primary Outcome Measure Information:
Title
Peak oxygen consumption (V02P) at 3 months after hospital discharge
Time Frame
3 months post-discharge
Secondary Outcome Measure Information:
Title
Change in 6 minute walk test distance from baseline to 3 months after hospital discharge
Description
distance walked in 6 minutes
Time Frame
Hospital discharge (baseline), 3 months post-discharge
Title
Change in muscle mass from baseline to 3 months after hospital discharge
Description
Measured by muscle sound
Time Frame
Hospital discharge (baseline), 3 months post-discharge
Title
Change in muscle strength from baseline to 3 months after hospital discharge
Description
Measured by Fried Frailty (includes Hand Grip strength)
Time Frame
Hospital discharge (baseline), 3 months post-discharge
Title
Change in muscle strength from baseline to 3 months after hospital discharge
Description
Measured by quadriceps strength (Quadricep muscle dynamometry)
Time Frame
Hospital discharge (baseline), 3 months post-discharge
Title
Cognition at 3 months after hospital discharge
Description
Measured by Repeatable Battery for Assessment of Neuropsychological Status (RBANS)
Time Frame
3 months post-discharge
Title
Change in cognition from baseline to 3 months after hospital discharge.
Description
Measured by Montreal Cognitive Assessment (MOCA)
Time Frame
Hospital discharge (baseline), 3 months post-discharge
Title
Change in cognition from baseline to 3 months after hospital discharge.
Description
Measured by Hayling Sentence Completion
Time Frame
Hospital discharge (baseline), 3 months post-discharge
Title
Change in cognition from baseline to 3 months after hospital discharge.
Description
Measured by PROMIS Cognitive function
Time Frame
Hospital discharge (baseline), 3 months post-discharge
Title
Change in cognition from 3 months to 6 months after hospital discharge.
Description
Measured by PROMIS Cognitive function
Time Frame
3 months post-discharge, 6 months post-hospital discharge
Title
Change in quality of life from baseline to 3 months after hospital discharge.
Description
Measured by Sociodemographic survey
Time Frame
Hospital discharge (baseline), 3 months post-discharge
Title
Change in quality of life from baseline to 3 months after hospital discharge.
Description
Measured by Employment Survey
Time Frame
Hospital discharge (baseline), 3 months post-discharge
Title
Change in quality of life from baseline to 3 months after hospital discharge.
Description
Measured by EQ-5D-5L
Time Frame
Hospital discharge (baseline), 3 months post-discharge
Title
Change in quality of life from baseline to 3 months after hospital discharge.
Description
Measured by Katz ADL/ Lawton IADL
Time Frame
Hospital discharge (baseline), 3 months post-discharge
Title
Change in quality of life from baseline to 3 months to 6 months after hospital discharge.
Description
Measured by Sociodemographic Survey
Time Frame
3 months post-discharge, 6 months post-hospital discharge
Title
Change in quality of life from baseline to 3 months to 6 months after hospital discharge.
Description
Measured by Employment Survey
Time Frame
3 months post-discharge, 6 months post-hospital discharge
Title
Change in quality of life from baseline to 3 months to 6 months after hospital discharge.
Description
Measured by EQ-5D-5L
Time Frame
3 months post-discharge, 6 months post-hospital discharge
Title
Change in quality of life from baseline to 3 months to 6 months after hospital discharge.
Description
Measured by Katz ADL/ Lawton IADL
Time Frame
3 months post-discharge, 6 months post-hospital discharge
Other Pre-specified Outcome Measures:
Title
Change in biomarkers of aging and resilience, and mitochondrial function from baseline to 3 months post-discharge
Description
Measured by peripheral blood mononuclear cell (PBMC)
Time Frame
Hospital discharge (baseline), 3 months post-discharge
Title
Change in biomarkers of aging and resilience, and mitochondrial function from baseline to 3 months post-discharge
Description
Measured by plasma
Time Frame
Hospital discharge (baseline), 3 months post-discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Wischmeyer, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs