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

Study Overview
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Brief Summary
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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
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REmotely Monitored, Mhealth (REMM) supported High Intensity Interval Training (HIIT) to improve recovery after Intensive Care Unit (ICU) 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.

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

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

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


Participation Criteria
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Eligibility Criteria
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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 > 30 days Not ambulating independently prior to COVID-19 illness (use of a gait aid permitted) Functional impairment resulting in inability to exercise at baseline (including need for home oxygen requirement) 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 screening 6IST (i.e., persistent oxygen saturation drop below 88-90% 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 Anticipated hospital discharge before baseline study measures could be completed 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: REmotely Monitored, Mobile health supported Multidomain Rehabilitation Program with HIIT<br>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)<br>* 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.<br>|
| No Intervention: Exercise education without personalized sessions or feedback<br>Patients will receive an exercise handout and iWatch/iPhone. Patients return home to exercise without personalized instruction and coaching. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Cardiorespiratory fitness | VO2P obtained during incremental Step Test | Baseline to 3 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 6 minute walk distance |  | Baseline to 3 month follow-up | 
| Change in physical function measured by Short Physical Performance Battery (SPPB) score. | Scores range from 0 (frailty) to 12 (robustness). | Baseline to 3 month follow-up | 
| Change in 30-sec sit to stand score |  | Baseline to 3 month follow-up | 
| Change in Fried Frailty Index Score | Score ranges from 0 (not frail) to 5 (frail). | Baseline to 3 month follow-up | 
| Change in cognitive ability as measured by the MoCA Test | Scores range from 0 to 30 with a lower score indicating more cognitive impairment. | Baseline to 3 months follow-up | 
| Cognitive ability as measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) | Scores range from 40 to 160 with a lower score indicating more cognitive impairment. | 6 month follow-up | 
| Change in muscle mass obtained via MuscleSound |  | Baseline to 3 month follow-up | 
| Diet by the GLIM criteria |  | 6 month follow-up | 
| Change in EQ-5D-5L Score | Scores range from -0.224 to 1, with 0, 1, and negative values corresponding to death, full health, and health states worse than death, respectively. | Baseline to 6 month follow-up | 
| Change in Duke Activity Status Index (DASI) Score | DASI scores range from 0 to 58.2, with a higher score indicating higher functional capacity. | Baseline to 6 month follow-up | 
| Change in PCL-5 Score | DASI scores range from 0 to 80, with a higher score indicating higher severity of PTSD symptoms. | Baseline to 6 month follow-up | 
| Compare cognitive ability as measured by PROMIS | Measured by PROMIS Cognitive function | 6 month follow-up | 
| Fatigue as measured by PROMIS | Measured by PROMIS Fatigue questionnaire | 6 month follow-up | 
| Physical function as measured by PROMIS | Measured by PROMIS Physical Function questionnaire | 6 month follow-up | 
| Emotional support as measured by PROMIS | Measured by PROMIS emotional support questionnaire | 6 month follow-up | 
| Social isolation as measured by PROMIS | Measured by PROMIS social isolation questionnaire | 6 month follow-up | 
| Change in and Lawton Score | Score ranges from 0 (very dependent) to 8 (high function, independent) | Baseline to 6 month follow-up | 
| Change in Katz Score | Score ranges from 0 (very dependent) to 6 (independent) | Baseline to 6 month follow-up | 
| Quality of life as measured by Social determinants of health (SDOH) survey |  | 6 month follow-up | 
| Change in IES-R | Score ranges from 0 to 88, with a higher score indicating more affect of routine life stress, everyday traumas and acute stress | Baseline to 6 month follow-up | 
| Change in Hospital Anxiety and Depression Scale (HADS) Scores | Scores ranges from 0 to 21 for both anxiety and depression, with a higher score indicating more symptoms of depression or anxiety | Baseline to 6 month follow-up | 
| Change in Posttraumatic Stress Disorder Checklist Score (PLC-5) | Score ranges from 0 to 80, with a higher score indicating more PTSD symptoms. | Baseline to 6 month follow-up | 
| Change in diet as measured by Diet History Questionnaire (DHQIII) |  | 6 month follow-up | 
| Quality of life as assessed by measured by financial assessment based on the FACIT COST assessment | Score ranges from 0 to 44 with a lower score indicating worse financial toxicity. | 6 month follow-up |