Mobile health program for rehabilitation after COVID-19

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, prospective, randomized controlled trial aims to provide mobile health-supported physical rehabilitation to 120 patients who have been critically ill with COVID-19. The program utilizes high intensity interval training (HIIT) to enhance recovery after hospital discharge. It evaluates clinical, physiological, and patient-centered outcomes associated with this remotely monitored rehabilitation approach. Participants must complete at least one exercise session to be included in the study.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Where it's running

• University of Alabama at Birmingham
  Birmingham, Alabama, United States Recruiting
• University of Kentucky
  Lexington, Kentucky, United States Recruiting
• Duke University Health System
  Durham, North Carolina, United States Recruiting
• The Ohio State University Wexner Medical Center
  Columbus, Ohio, United States Recruiting
• Vanderbilt University Medical Center
  Nashville, Tennessee, United States Recruiting

Study contacts

• Principal investigator: Paul Wischmeyer, MD — Duke Clinical Research Institute
• Study coordinator: Marjan Cobbaert, MPH
• Email: marjan.cobbaert@duke.edu
• Phone: 919-668-9740

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.