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

Duke University120 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

120

Conditions

COVID-19 Critical Illness ICU Acquired Weakness PICS Cardiorespiratory Fitness

Interventions

REmotely monitored, Mobile health supported Multidomain Rehabilitation Program with High Intensity Interval Training (REMM-HIIT)BEHAVIORAL

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

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

University of Alabama at Birmingham

Birmingham, Alabama, United States

RECRUITING

University of Kentucky

Lexington, Kentucky, United States

RECRUITING

Duke University Health System

Durham, North Carolina, United States