REmotely Monitored, Mobile Health Supported Multidomain Rehabilitation Program With High Intensity Interval Training for COVID-19 (REMM-HIIT-CoV)

Duke University

Status: Enrolling

Conditions: COVID-19; PICS; Critical Illness; ICU Acquired Weakness; Cardiorespiratory Fitness

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05218083

1R01HD107103 (U.S. NIH Grant/Contract)

Pro00109644

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

120 participants in 2 patient groups

REmotely Monitored, Mobile health supported Multidomain Rehabilitation Program with HIIT

Experimental group

Description:

Patients will receive our REmotely monitored, Mobile health supported Multidomain Rehabilitation Program with High Intensity Interval Training Program (REMM-HIIT) with iWatch/iPhone.

Treatment:

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

Exercise education without personalized sessions or feedback

No Intervention group

Description:

Patients will receive an exercise handout and iWatch/iPhone. Patients return home to exercise without personalized instruction and coaching.