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Completed

NCT Number: NCT04664101

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

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

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Critical Illness Disease Attributes Fitness Trackers High Intensity Interval Training ICU Infections Intensive Care Units Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center, Durham, North Carolina, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Behavioral

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

Other

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 outcomes

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

    Time frame: 3 months post-discharge

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Vanderbilt University

Registry information

Acronym: REMMHIIT-COVID

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 11, 2020
Registry last updated
Jan 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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