No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
120 (estimated)
Sponsor
Duke University · Other
Who this trial is looking for
This trial is looking for people who have been seriously ill with COVID-19 and are ready to go home from the hospital. Participants will receive support for a physical rehabilitation program that includes exercise sessions monitored through mobile health technology.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with COVID-19 and needed hospital care.
I am going straight home from the hospital.
I can walk with or without a walking aid.
I am at least 18 years old.
You may not be able to join if
I was discharged from the hospital more than 60 days ago.
I was unable to walk independently before getting COVID-19.
I have a severe health issue that stops me from exercising.
I cannot follow the study’s rules or mobile health instructions.
I have serious heart problems or high blood pressure.
I have had any dangerous changes during exercise testing.
I have a condition that makes it unsafe for me to participate.
I am pregnant.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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Status
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…
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
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