Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05218083

REmotely Monitored, Mobile Health Supported Multidomain Rehabilitation Program With High Intensity Interval Training for COVID-19

Led by Duke University · Updated on 2026-05-06

120

Participants Needed

5

Research Sites

192 weeks

Total Duration

On this page

Sponsors

D

Duke University

Lead Sponsor

E

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Multicenter, prospective, randomized controlled trial providing mobile health supported physical rehabilitation to 120 patients who have been critically ill with COVID-19 and who complete at least one exercise session.

CONDITIONS

Official Title

REmotely Monitored, Mobile Health Supported Multidomain Rehabilitation Program With High Intensity Interval Training for COVID-19

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Primary diagnosis of COVID-19 requiring hospital admission
  • Discharged or expected to be discharged directly home from the hospital (not to a skilled nursing facility, inpatient rehabilitation center, or long-term acute care hospital)
  • Able to ambulate with or without a gait aid prior to hospital discharge
  • Age ≥ 18 years
Not Eligible

You will not qualify if you...

  • Hospital discharge > 60 days unless readmitted to hospital in first 30 days, then 60 day window restarts and new exclusion is last hospital discharge > 60 days

  • Not ambulating independently prior to COVID-19 illness (use of a gait aid permitted)

  • Functional impairment resulting in inability to exercise at baseline

  • Inability or unwillingness to comply with the study requirements or unable or unwilling to follow coaching via mobile-health iPhone interaction

  • Any absolute contraindications to exercise, including but not limited to:

    • Recent (< 5 days) acute primary cardiac event
    • Unstable Angina
    • Uncontrolled dysrhythmias causing symptoms or hemodynamic compromise
    • Uncontrolled hypertension over 255 mmHg Systolic or 155 diastolic blood pressure
    • Symptomatic aortic stenosis
    • Uncontrolled symptomatic heart failure
    • Acute myocarditis or pericarditis
    • Suspected or known dissecting aneurysm
  • Any adverse changes during GXT (i.e., persistent oxygen saturation drop below 88% while on prescribed oxygen therapy or significant hypotension such as mean arterial blood pressure < 60 mmHg on 2 consecutive readings within 1 minute)

  • High risk for non-adherence as determined by screening evaluation

  • Any condition, including cognitive impairment, that, in the judgment of the investigator, precludes participation because it could affect subject safety or ability of subject to complete the study

  • Pregnant

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35233

Actively Recruiting

2

University of Kentucky

Lexington, Kentucky, United States, 40536

Actively Recruiting

3

Duke University Health System

Durham, North Carolina, United States, 27710

Actively Recruiting

4

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States, 43201

Actively Recruiting

5

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37203

Actively Recruiting

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Research Team

M

Marjan Cobbaert, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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REmotely Monitored, Mobile Health Supported Multidomain Rehabilitation Program With High Intensity Interval Training for COVID-19 | DecenTrialz