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

Launched by DUKE UNIVERSITY · Jan 31, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new rehabilitation program designed to help patients who have been seriously ill with COVID-19. The program includes high-intensity interval training, which is a type of exercise that alternates between short bursts of intense activity and rest. Researchers want to see if this mobile health-supported program can improve the physical fitness and overall recovery of 120 patients after their hospital stay.

To join the study, participants must be at least 18 years old and have been diagnosed with COVID-19 that required hospitalization. They should be able to walk, even with the help of a device, and must be expected to go directly home after leaving the hospital. Participants will engage in guided exercises through their smartphones, allowing them to receive support and coaching from home. It's important to note that some individuals, such as those with certain heart conditions or who are unable to follow the study requirements, may not be eligible to participate.

Gender

ALL

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