REmotely Monitored, Mobile Health Supported Multidomain Rehabilitation Program With High Intensity Interval Training for COVID-19
NCT ID: NCT05218083
Last Updated: 2025-06-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2023-02-23
2026-11-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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REmotely Monitored, Mobile health supported Multidomain Rehabilitation Program with HIIT
Patients will receive our REmotely monitored, Mobile health supported Multidomain Rehabilitation Program with High Intensity Interval Training Program (REMM-HIIT) with iWatch/iPhone.
REmotely monitored, Mobile health supported Multidomain Rehabilitation Program with High Intensity Interval Training (REMM-HIIT)
REmotely Monitored, Mobile health-supported, High Intensity Interval Training consists of remotely monitored tailored, structured, progressive multidomain physical rehabilitation \& personalized instruction \& coaching.
Patients complete 3 structured exercise sessions/week consisting of HIIT, strength, balance, and mobility exercises. Following warmup, patients increase workload at a heart rate corresponding to 95% VO2peak for 1-minute before returning to warm-up speed for 1-minute at a heart rate corresponding to 60% VO2peak.
Strength includes functional strengthening exercises for lower extremities \& general resistance exercises for major muscle groups.
Balance incorporates static \& dynamic exercises, including progressively narrowing base of support with eyes open or closed, reaching forward \& backward starting within base of support \& progressing to outside base of support.
Mobility rehabilitation includes dynamic start/stop while walking and changing direction while walking.
Exercise education without personalized sessions or feedback
Patients will receive an exercise handout and iWatch/iPhone. Patients return home to exercise without personalized instruction and coaching.
No interventions assigned to this group
Interventions
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REmotely monitored, Mobile health supported Multidomain Rehabilitation Program with High Intensity Interval Training (REMM-HIIT)
REmotely Monitored, Mobile health-supported, High Intensity Interval Training consists of remotely monitored tailored, structured, progressive multidomain physical rehabilitation \& personalized instruction \& coaching.
Patients complete 3 structured exercise sessions/week consisting of HIIT, strength, balance, and mobility exercises. Following warmup, patients increase workload at a heart rate corresponding to 95% VO2peak for 1-minute before returning to warm-up speed for 1-minute at a heart rate corresponding to 60% VO2peak.
Strength includes functional strengthening exercises for lower extremities \& general resistance exercises for major muscle groups.
Balance incorporates static \& dynamic exercises, including progressively narrowing base of support with eyes open or closed, reaching forward \& backward starting within base of support \& progressing to outside base of support.
Mobility rehabilitation includes dynamic start/stop while walking and changing direction while walking.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Vanderbilt University Medical Center
OTHER
Ohio State University
OTHER
University of Kentucky
OTHER
University of Alabama at Birmingham
OTHER
Florida Atlantic University
OTHER
Duke University
OTHER
Responsible Party
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Principal Investigators
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Paul Wischmeyer, MD
Role: PRINCIPAL_INVESTIGATOR
Duke Clinical Research Institute
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Kentucky
Lexington, Kentucky, United States
Duke University Health System
Durham, North Carolina, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Countries
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Central Contacts
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Facility Contacts
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Peter Morris, MD
Role: primary
Kirby Mayer, PT, DPT, PhD
Role: primary
Amy Pastva, PT, PhD
Role: primary
Nathan Brummel, MD
Role: primary
E Wesley Ely, MD
Role: primary
Other Identifiers
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Pro00109644
Identifier Type: -
Identifier Source: org_study_id
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