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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HD107103 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| Vanderbilt University Medical Center | OTHER |
| Ohio State University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REmotely Monitored, Mobile health supported Multidomain Rehabilitation Program with HIIT | Experimental | Patients will receive our REmotely monitored, Mobile health supported Multidomain Rehabilitation Program with High Intensity Interval Training Program (REMM-HIIT) with iWatch/iPhone. |
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| Exercise education without personalized sessions or feedback | No Intervention | Patients will receive an exercise handout and iWatch/iPhone. Patients return home to exercise without personalized instruction and coaching. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REmotely monitored, Mobile health supported Multidomain Rehabilitation Program with High Intensity Interval Training (REMM-HIIT) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 6 minute walk distance | distance walked in m | Baseline to 3 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cardiorespiratory fitness | VO2P obtained during incremental Step Test | Baseline to 3 month follow-up |
| Change in physical function measured by Short Physical Performance Battery (SPPB) score. |
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Inclusion Criteria:
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:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marjan Cobbaert, MPH | Contact | 919-668-9740 | marjan.cobbaert@duke.edu |
| Name | Affiliation | Role |
|---|---|---|
| Paul Wischmeyer, MD | Duke Clinical Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Recruiting | Birmingham | Alabama | 35233 | United States |
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| University of Kentucky |
| OTHER |
| University of Alabama at Birmingham | OTHER |
| Florida Atlantic University | OTHER |
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Scores range from 0 (frailty) to 12 (robustness).
| Baseline to 3 month follow-up |
| Change in 30-sec sit to stand score | Number of times the patient comes to a full standing position in 30 seconds | 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 |
| Change in muscle mass obtained via MuscleSound | Change in IMAT index as measured by MuscleSound | Baseline to 3 month follow-up |
| Compare EQ-5D-5L Score between intervention and control group | Scores range from -0.59 to where 1 is the best possible health state. Negative values represent health states perceived as worse than death, which is equal to 0 | Baseline |
| Compare EQ-5D-5L Score between intervention and control group | Scores range from -0.59 to where 1 is the best possible health state. Negative values represent health states perceived as worse than death, which is equal to 0 | 3 month visit |
| Compare EQ-5D-5L Score between intervention and control group | Scores range from -0.59 to where 1 is the best possible health state. Negative values represent health states perceived as worse than death, which is equal to 0 | 6 month visit |
| Compare Duke Activity Status Index (DASI) Score between intervention and control group | DASI scores range from 0 to 58.2, with a higher score indicating higher functional capacity. | Baseline |
| Compare Duke Activity Status Index (DASI) Score between intervention and control group | DASI scores range from 0 to 58.2, with a higher score indicating higher functional capacity. | 3 months |
| Compare Duke Activity Status Index (DASI) Score between intervention and control group | DASI scores range from 0 to 58.2, with a higher score indicating higher functional capacity. | 6 months |
| Compare Lawton Score between intervention and control group | Score ranges from 0 (very dependent) to 8 (high function, independent) | Baseline |
| Compare Lawton Score between intervention and control group | Score ranges from 0 (very dependent) to 8 (high function, independent) | 3 months |
| Compare Lawton Score between intervention and control group | Score ranges from 0 (very dependent) to 8 (high function, independent) | 6 months |
| Compare Hospital Anxiety and Depression Scale (HADS) Score between intervention and control group | Scores ranges from 0 to 21 for both anxiety and depression, with a higher score indicating more symptoms of depression or anxiety | Baseline |
| Compare Hospital Anxiety and Depression Scale (HADS) Score between intervention and control group | Scores ranges from 0 to 21 for both anxiety and depression, with a higher score indicating more symptoms of depression or anxiety | 3 months |
| Compare Hospital Anxiety and Depression Scale (HADS) Score between intervention and control group | Scores ranges from 0 to 21 for both anxiety and depression, with a higher score indicating more symptoms of depression or anxiety | 6 months |
| Compare social determinants of health between intervention and control group | Completion of the Accountable Health Communities Health-Related Social Needs Screening Tool. A higher score indicates a higher Health-related social need. | 3 months |
| Compare social determinants of health between intervention and control group | Completion of the Accountable Health Communities Health-Related Social Needs Screening Tool. A higher score indicates a higher Health-related social need. | 6 months |
| University of Kentucky | Recruiting | Lexington | Kentucky | 40536 | United States |
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| Duke University Health System | Recruiting | Durham | North Carolina | 27710 | United States |
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| The Ohio State University Wexner Medical Center | Recruiting | Columbus | Ohio | 43201 | United States |
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| Vanderbilt University Medical Center | Recruiting | Nashville | Tennessee | 37203 | United States |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000072696 | High-Intensity Interval Training |
| ID | Term |
|---|---|
| D064797 | Physical Conditioning, Human |
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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