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

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.

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.

Interventions

• 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 r

Primary outcome measures

• Change in 6 minute walk distance [Time frame: Baseline to 3 month follow-up]

Secondary outcome measures (12)

• Change in Cardiorespiratory fitness [Time frame: Baseline to 3 month follow-up]
• Change in physical function measured by Short Physical Performance Battery (SPPB) score. [Time frame: Baseline to 3 month follow-up]
• Change in 30-sec sit to stand score [Time frame: Baseline to 3 month follow-up]
• Change in Fried Frailty Index Score [Time frame: Baseline to 3 month follow-up]
• Change in cognitive ability as measured by the MoCA Test [Time frame: Baseline to 3 months follow-up]
• Change in muscle mass obtained via MuscleSound [Time frame: Baseline to 3 month follow-up]
• Compare EQ-5D-5L Score between intervention and control group [Time frame: Baseline]
• Compare EQ-5D-5L Score between intervention and control group [Time frame: 3 month visit]
• Compare EQ-5D-5L Score between intervention and control group [Time frame: 6 month visit]
• Compare Duke Activity Status Index (DASI) Score between intervention and control group [Time frame: Baseline]
• Compare Duke Activity Status Index (DASI) Score between intervention and control group [Time frame: 3 months]
• Compare Duke Activity Status Index (DASI) Score between intervention and control group [Time frame: 6 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 5 centers

• University of Alabama at Birmingham — Birmingham
• University of Kentucky — Lexington
• Duke University Health System — Durham
• The Ohio State University Wexner Medical Center — Columbus
• Vanderbilt University Medical Center — Nashville

Identifiers

NCT: NCT05218083 · Pro00109644 · 1R01HD107103

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗