Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04664101
Recruitment Status : Not yet recruiting
First Posted : December 11, 2020
Last Update Posted : January 19, 2022
Sponsor:
Collaborator:
Vanderbilt University
Information provided by (Responsible Party):
Duke University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Not Applicable

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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)
Estimated Study Start Date : March 1, 2022
Estimated Primary Completion Date : January 1, 2024
Estimated Study Completion Date : January 1, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Peak oxygen consumption (V02P) at 3 months after hospital discharge [ Time Frame: 3 months post-discharge ]

Secondary Outcome Measures :
  1. Change in 6 minute walk test distance from baseline to 3 months after hospital discharge [ Time Frame: Hospital discharge (baseline), 3 months post-discharge ]
    distance walked in 6 minutes

  2. Change in muscle mass from baseline to 3 months after hospital discharge [ Time Frame: Hospital discharge (baseline), 3 months post-discharge ]
    Measured by muscle sound

  3. Change in muscle strength from baseline to 3 months after hospital discharge [ Time Frame: Hospital discharge (baseline), 3 months post-discharge ]
    Measured by Fried Frailty (includes Hand Grip strength)

  4. Change in muscle strength from baseline to 3 months after hospital discharge [ Time Frame: Hospital discharge (baseline), 3 months post-discharge ]
    Measured by quadriceps strength (Quadricep muscle dynamometry)

  5. Cognition at 3 months after hospital discharge [ Time Frame: 3 months post-discharge ]
    Measured by Repeatable Battery for Assessment of Neuropsychological Status (RBANS)

  6. Change in cognition from baseline to 3 months after hospital discharge. [ Time Frame: Hospital discharge (baseline), 3 months post-discharge ]
    Measured by Montreal Cognitive Assessment (MOCA)

  7. Change in cognition from baseline to 3 months after hospital discharge. [ Time Frame: Hospital discharge (baseline), 3 months post-discharge ]
    Measured by Hayling Sentence Completion

  8. Change in cognition from baseline to 3 months after hospital discharge. [ Time Frame: Hospital discharge (baseline), 3 months post-discharge ]
    Measured by PROMIS Cognitive function

  9. Change in cognition from 3 months to 6 months after hospital discharge. [ Time Frame: 3 months post-discharge, 6 months post-hospital discharge ]
    Measured by PROMIS Cognitive function

  10. Change in quality of life from baseline to 3 months after hospital discharge. [ Time Frame: Hospital discharge (baseline), 3 months post-discharge ]
    Measured by Sociodemographic survey

  11. Change in quality of life from baseline to 3 months after hospital discharge. [ Time Frame: Hospital discharge (baseline), 3 months post-discharge ]
    Measured by Employment Survey

  12. Change in quality of life from baseline to 3 months after hospital discharge. [ Time Frame: Hospital discharge (baseline), 3 months post-discharge ]
    Measured by EQ-5D-5L

  13. Change in quality of life from baseline to 3 months after hospital discharge. [ Time Frame: Hospital discharge (baseline), 3 months post-discharge ]
    Measured by Katz ADL/ Lawton IADL

  14. Change in quality of life from baseline to 3 months to 6 months after hospital discharge. [ Time Frame: 3 months post-discharge, 6 months post-hospital discharge ]
    Measured by Sociodemographic Survey

  15. Change in quality of life from baseline to 3 months to 6 months after hospital discharge. [ Time Frame: 3 months post-discharge, 6 months post-hospital discharge ]
    Measured by Employment Survey

  16. Change in quality of life from baseline to 3 months to 6 months after hospital discharge. [ Time Frame: 3 months post-discharge, 6 months post-hospital discharge ]
    Measured by EQ-5D-5L

  17. Change in quality of life from baseline to 3 months to 6 months after hospital discharge. [ Time Frame: 3 months post-discharge, 6 months post-hospital discharge ]
    Measured by Katz ADL/ Lawton IADL


Other Outcome Measures:
  1. Change in biomarkers of aging and resilience, and mitochondrial function from baseline to 3 months post-discharge [ Time Frame: Hospital discharge (baseline), 3 months post-discharge ]
    Measured by peripheral blood mononuclear cell (PBMC)

  2. Change in biomarkers of aging and resilience, and mitochondrial function from baseline to 3 months post-discharge [ Time Frame: Hospital discharge (baseline), 3 months post-discharge ]
    Measured by plasma


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04664101


Contacts
Layout table for location contacts
Contact: Paul Wischmeyer, MD 919-681-4377 paul.wischmeyer@duke.edu
Contact: Alice Szydlowska 919-681-4377 alicja.szydlowska@duke.edu

Locations
Layout table for location information
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Contact: Alicja Szydlowska    919-681-4377      
Contact       alicja.szydlowska@duke.edu   
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
Contact: Matthew Mart, MD         
Sponsors and Collaborators
Duke University
Vanderbilt University
Investigators
Layout table for investigator information
Principal Investigator: Paul Wischmeyer, MD Duke University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04664101    
Other Study ID Numbers: Pro00105798
First Posted: December 11, 2020    Key Record Dates
Last Update Posted: January 19, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Duke University:
critical care
Covid19
ICU
high intensity interval training
 intensive care unit
critical illness
fitness trackers
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Critical Illness
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
 Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes