Clinical trial NCT05218083: REmotely Monitored, Mobile Health Supported Multidomain Rehabilitation Program With High Intensity Interval Training for COVID-19
Official title: REmotely Monitored, Mobile Health Supported Multidomain Rehabilitation Program With High Intensity Interval Training for COVID-19
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: COVID-19
Critical Illness
ICU Acquired Weakness
PICS
Cardiorespiratory Fitness
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Vanderbilt University Medical Center
name: Ohio State University
name: University of Kentucky
name: University of Alabama at Birmingham
name: Florida Atlantic University
First posted: 2022-02-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

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 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

Primary outcomes:
measure: Change in 6 minute walk distance
timeFrame: Baseline to 3 month follow-up
Secondary outcomes:
measure: Change in Cardiorespiratory fitness
timeFrame: Baseline to 3 month follow-up
measure: Change in physical function measured by Short Physical Performance Battery (SPPB) score.
timeFrame: Baseline to 3 month follow-up
measure: Change in 30-sec sit to stand score
timeFrame: Baseline to 3 month follow-up
measure: Change in Fried Frailty Index Score
timeFrame: Baseline to 3 month follow-up
measure: Change in cognitive ability as measured by the MoCA Test
timeFrame: Baseline to 3 months follow-up
measure: Change in muscle mass obtained via MuscleSound
timeFrame: Baseline to 3 month follow-up
measure: Compare EQ-5D-5L Score between intervention and control group
timeFrame: Baseline
measure: Compare EQ-5D-5L Score between intervention and control group
timeFrame: 3 month visit
measure: Compare EQ-5D-5L Score between intervention and control group
timeFrame: 6 month visit
measure: Compare Duke Activity Status Index (DASI) Score between intervention and control group
timeFrame: Baseline
measure: Compare Duke Activity Status Index (DASI) Score between intervention and control group
timeFrame: 3 months
measure: Compare Duke Activity Status Index (DASI) Score between intervention and control group
timeFrame: 6 months
measure: Compare Lawton Score between intervention and control group
timeFrame: Baseline
measure: Compare Lawton Score between intervention and control group
timeFrame: 3 months
measure: Compare Lawton Score between intervention and control group
timeFrame: 6 months
measure: Compare Hospital Anxiety and Depression Scale (HADS) Score between intervention and control group
timeFrame: Baseline
measure: Compare Hospital Anxiety and Depression Scale (HADS) Score between intervention and control group
timeFrame: 3 months
measure: Compare Hospital Anxiety and Depression Scale (HADS) Score between intervention and control group
timeFrame: 6 months
measure: Compare social determinants of health between intervention and control group
timeFrame: 3 months
measure: Compare social determinants of health between intervention and control group
timeFrame: 6 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Duke Clinical Research Institute
name: Paul Wischmeyer, MD
role: PRINCIPAL_INVESTIGATOR
References: