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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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.
  • Behavioral: 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.
No Intervention
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.

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35233
Contact:
Peter Morris, MD

The Ohio State University Wexner Medical Center
Columbus, Ohio 43201
Contact:
Nathan Brummel, MD

More Details

NCT ID
NCT05218083
Status
Recruiting
Sponsor
Duke University

Study Contact

Marjan Cobbaert, MPH
919-668-9740
marjan.cobbaert@duke.edu

Detailed Description

REmotely Monitored, Mhealth (REMM) supported High Intensity Interval Training (HIIT) to improve recovery after hospital discharge in patients with COVID-19 will evaluate the feasibility of clinical-, physiological- and patient-centered outcomes associated with a remotely monitored, mobile health-supported high intensity interval rehabilitation exercise training to improve the functional recovery of survivors who have experienced critical illness with COVID-19 and have been discharged home from the hospital.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.