REMM-HIIT-CoV: REmotely Monitored, Mobile Health Supported Multidomain Rehabilitation Program With High Intensity Interval Training for COVID-19
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: REmotely Monitored, Mobile health supported Multidomain Rehabilitation Program with HIIT 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)
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.
|
| No Intervention: Exercise education without personalized sessions or feedback Patients will receive an exercise handout and iWatch/iPhone. Patients return home to exercise without personalized instruction and coaching. |
Outcome Measures
Primary Outcome Measures
- Change in Cardiorespiratory fitness [Baseline to 3 months after hospital discharge]
VO2P obtained during incremental 6 Minute Step Test
Secondary Outcome Measures
- Change in 6 minute walk distance [Baseline to 3 months after hospital discharge]
- Change in physical function measured by Short Physical Performance Battery (SPPB) score. [Baseline to 3 months after hospital discharge]
Scores range from 0 (frailty) to 12 (robustness).
- Change in 30-sec sit to stand score [Baseline to 3 months after hospital discharge]
- Change in Fried Frailty Index Score [Baseline to 3 months after hospital discharge]
Score ranges from 0 (not frail) to 5 (frail).
- Change in cognitive ability [Baseline to 3 months after hospital discharge]
Measured by the Montreal Cognitive Assessment (MoCA) Test. Scores range from 0 to 30 with a lower score indicating more cognitive impairment.
- Change in cognitive ability [Baseline to 3 months after hospital discharge]
Measured by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Score. Scores range from 40 to 160 with a lower score indicating more cognitive impairment.
- Change in cognitive ability [Baseline to 3 months after hospital discharge]
Measured by the Hayling Scaled Score. Scores range from 1 (impaired) to 10 (very superior).
- Change in muscle mass obtained via MuscleSound [Baseline to 3 months after hospital discharge]
- Change in diet [Baseline to 3 months after hospital discharge]
measured by the GLIM Criteria
- Change in EQ-5D-5L Score [Baseline to 6 months after hospital discharge]
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.
- Change in Duke Activity Status Index (DASI) Score [Baseline to 6 months after hospital discharge]
DASI scores range from 0 to 58.2, with a higher score indicating higher functional capacity.
- Change in cognition from baseline to 3 months after hospital discharge [Baseline to 6 months after hospital discharge]
Measured by PROMIS Cognitive function
- Change in fatigue from baseline to 3 months after hospital discharge [Baseline to 6 months after hospital discharge]
Measured by PROMIS Fatigue questionnaire
- Change in physical function from baseline to 3 months after hospital discharge [Baseline to 6 months after hospital discharge]
Measured by PROMIS Physical Function questionnaire
- Change in emotional support from baseline to 3 months after hospital discharge [Baseline to 6 months after hospital discharge]
Measured by PROMIS emotional support questionnaire
- Change in social isolation from baseline to 3 months after hospital discharge [Baseline to 6 months after hospital discharge]
Measured by PROMIS social isolation questionnaire
- Change in and Lawton Score [Baseline to 6 months after hospital discharge]
Score ranges from 0 (very dependent) to 8 (high function, independent)
- Change in Katz Score [Baseline to 6 months after hospital discharge]
Score ranges from 0 (very dependent) to 6 (independent)
- Change in quality of life [Baseline to 6 months after hospital discharge]
Measured by Social determinants of health (SDOH) survey
- Change in IES-R [Baseline to 6 months after hospital discharge]
Score ranges from 0 to 88, with a higher score indicating more affect of routine life stress, everyday traumas and acute stress
- Change in Hospital Anxiety and Depression Scale (HADS) Scores [Baseline to 6 months after hospital discharge]
Scores ranges from 0 to 21 for both anxiety and depression, with a higher score indicating more symptoms of depression or anxiety
- Change in Posttraumatic Stress Disorder Checklist Score (PLC-5) [Baseline to 6 months after hospital discharge]
Score ranges from 0 to 80, with a higher score indicating more PTSD symptoms.
- Change in diet [Baseline to 6 months after hospital discharge]
measured by Diet History Questionnaire (DHQIII)
- Change in quality of life [Baseline to 6 months after hospital discharge]
Measured by financial assessment based on the FACIT COST assessment
Other Outcome Measures
- Change in mitochondrial function [Baseline and 6 months post-hospital discharge]
blood collection
- Change in biomarkers of inflammation [Baseline and 6 months post-hospital discharge]
blood collection
- Change in biomarkers of aging [Baseline and 6 months post-hospital discharge]
blood collection
Eligibility Criteria
Criteria
Inclusion Criteria:
-
ICU admission and subsequent discharge for primary diagnosis of COVID-19 respiratory failure or infection requiring treatment with noninvasive ventilation (i.e., BiPap), High Flow Nasal Cannula O2, or Invasive mechanical ventilation for ≥ 48 hours with an ICU length of stay of ≥ 4 days.
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Expected to be discharged directly home from the hospital (not to a skilled nursing facility, inpatient rehabilitation center, or long-term acute care hospital)
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Able to ambulate with or without a gait aid prior to hospital discharge
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Age ≥ 18 years
Exclusion Criteria:
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Not ambulating independently prior to COVID-19 illness (use of a gait aid permitted)
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Functional impairment resulting in inability to exercise at hospital discharge (including need for home oxygen requirement)
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Inability or unwillingness to comply with the study requirements or unable or unwilling to follow coaching via mobile-health iPhone interaction
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Any absolute contraindications to exercise, including but not limited to:
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Recent (< 5 days) acute primary cardiac event
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Unstable Angina
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Uncontrolled dysrhythmias causing symptoms or hemodynamic compromise
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Uncontrolled hypertension over 255 mmHg Systolic or 155 diastolic blood pressure
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Symptomatic aortic stenosis
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Uncontrolled symptomatic heart failure
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Acute myocarditis or pericarditis
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Suspected or known dissecting aneurysm
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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)
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High risk for non-adherence as determined by screening evaluation
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Anticipated hospital discharge before baseline study measures could be completed
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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
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Pregnant
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Duke University
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Vanderbilt University Medical Center
- Ohio State University
- University of Kentucky
- University of Alabama at Birmingham
Investigators
- Principal Investigator: Paul Wischmeyer, MD, Duke Clinical Research Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Pro00109644
- 1R01HD107103