Mobile health program for rehabilitation after COVID-19
REmotely Monitored, Mobile Health Supported Multidomain Rehabilitation Program With High Intensity Interval Training for COVID-19
This study is testing a mobile health program that uses high intensity exercise to help 120 patients recover better after being seriously ill with COVID-19.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 5 sites (Birmingham, Alabama and 4 other locations) |
| Trial ID | NCT05218083 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who were hospitalized due to COVID-19 and are able to ambulate with or without assistance prior to discharge.
Not a fit: Patients who have significant functional impairments preventing them from exercising or those with recent acute cardiac events may not benefit from this program.
Why it matters
Potential benefit: If successful, this program could significantly improve the functional recovery and overall health of COVID-19 survivors after hospital discharge.
How similar studies have performed: Other studies have shown promise in using mobile health technologies for rehabilitation, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Birmingham, Alabama and 4 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.