NCT05218083 REmotely Monitored, Mobile Health Supported Multidomain Rehabilitation Program With High Intensity Interval Training for COVID-19
| NCT ID | NCT05218083 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Duke University |
| Condition | COVID-19 |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2023-02-23 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2023-02-23 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Paul Wischmeyer, MD
PRINCIPAL INVESTIGATOR
Duke Clinical Research Institute
Frequently Asked Questions
Who can join the NCT05218083 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying COVID-19. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05218083 currently recruiting?
Yes, NCT05218083 is actively recruiting participants. Contact the research team at marjan.cobbaert@duke.edu for enrollment information.
Where is the NCT05218083 trial being conducted?
This trial is being conducted at Birmingham, United States, Lexington, United States, Durham, United States, Columbus, United States and 1 additional location.
Who is sponsoring the NCT05218083 clinical trial?
NCT05218083 is sponsored by Duke University. The principal investigator is Paul Wischmeyer, MD at Duke Clinical Research Institute. The trial plans to enroll 120 participants.
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