REmotely Monitored, Mobile Health Supported Multidomain Rehabilitation Program With High Intensit… (NCT05218083) | Clinical Trial Compass
RecruitingNot Applicable
REmotely Monitored, Mobile Health Supported Multidomain Rehabilitation Program With High Intensity Interval Training for COVID-19
United States120 participantsStarted 2023-02-23
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial focuses on people recovering from severe COVID-19 who developed ICU-acquired weakness or post-intensive care syndrome — does my specific situation after COVID-19 match the kind of recovery this program is designed for?
2The exercise component involves high-intensity interval training, which is more demanding than standard gentle rehab — given my current cardiorespiratory fitness level after my illness, is it safe for me to attempt that level of intensity right now?
3The program is described as remotely monitored and mobile health supported, meaning I'd likely be doing much of this from home using an app or device — do I have the right technology, internet access, and physical setup at home to realistically participate?
4The trial measures improvement in 6-minute walk distance as its main outcome — what does my current ability to walk and exercise look like compared to where this trial expects participants to start, and is that a meaningful goal for my recovery?
5Since this trial doesn't have a traditional phase number, meaning it may still be establishing how well this approach works rather than confirming proven benefit — is there a more established rehabilitation program I should consider first, or does my doctor think this trial could still be a good fit for my stage of recovery?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.