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

January 17, 2024 updated by: Duke University
REmotely Monitored, Mobile Health-Supported High Intensity Interval Training after COVID-19 critical illness (REMM-HIIT-COVID-19)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
13

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Peak oxygen consumption (V02P) at 3 months after hospital discharge
Time Frame: 3 months post-discharge
3 months post-discharge

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Hospital discharge (baseline), 3 months post-discharge
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
Hospital discharge (baseline), 3 months post-discharge
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)
Hospital discharge (baseline), 3 months post-discharge
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)
Hospital discharge (baseline), 3 months post-discharge
Cognition at 3 months after hospital discharge
Time Frame: 3 months post-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.
Time Frame: Hospital discharge (baseline), 3 months post-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.
Time Frame: Hospital discharge (baseline), 3 months post-discharge
Measured by Hayling Sentence Completion
Hospital discharge (baseline), 3 months post-discharge
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
Hospital discharge (baseline), 3 months post-discharge
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
3 months post-discharge, 6 months post-hospital discharge
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
Hospital discharge (baseline), 3 months post-discharge
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
Hospital discharge (baseline), 3 months post-discharge
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
Hospital discharge (baseline), 3 months post-discharge
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
Hospital discharge (baseline), 3 months post-discharge
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
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.
Time Frame: 3 months post-discharge, 6 months post-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.
Time Frame: 3 months post-discharge, 6 months post-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.
Time Frame: 3 months post-discharge, 6 months post-hospital discharge
Measured by Katz ADL/ Lawton IADL
3 months post-discharge, 6 months post-hospital discharge

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
Hospital discharge (baseline), 3 months post-discharge
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
Hospital discharge (baseline), 3 months post-discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Vanderbilt University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Paul Wischmeyer, MD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 2, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 10, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 11, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 18, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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