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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05218083
Other study ID # Pro00109644
Secondary ID 1R01HD107103
Status Recruiting
Phase N/A
First received
Last updated
Start date February 23, 2023
Est. completion date June 1, 2027

Study information

Verified date April 2024
Source Duke University
Contact Marjan Cobbaert, MPH
Phone 919-668-9740
Email marjan.cobbaert@duke.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date June 1, 2027
Est. primary completion date March 1, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 IST (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

Study Design


Intervention

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.

Locations

Country Name City State
United States University of Alabama at Birmingham Birmingham Alabama
United States The Ohio State University Wexner Medical Center Columbus Ohio
United States Duke University Health System Durham North Carolina
United States Vanderbilt University Medical Center Nashville Tennessee

Sponsors (7)

Lead Sponsor Collaborator
Duke University Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Florida Atlantic University, Ohio State University, University of Alabama at Birmingham, University of Kentucky, Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Change in mitochondrial function blood collection Baseline and 6 months post-hospital discharge
Other Change in biomarkers of inflammation Lower concentrations (pg/mL) of IL-6 , NF-alpha in blood show reduced systemic inflammation Baseline and 6 months post-hospital discharge
Other Change in biomarkers of inflammation Lower concentrations (ng/mL) of D-Dimer in blood show reduced systemic inflammation Baseline and 6 months post-hospital discharge
Other Change in biomarkers of aging Concentration (ng/mL) TNFR-I and TNFR-II in blood, with lower TNFR-I and TNFR-II showing reduced aging Baseline and 6 months post-hospital discharge
Primary Change in 6 minute walk distance distance walked in m Baseline to 3 month follow-up
Secondary 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
Secondary 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
Secondary Change in Fried Frailty Index Score Score ranges from 0 (not frail) to 5 (frail). Baseline to 3 month follow-up
Secondary 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
Secondary Change in muscle mass obtained via MuscleSound Change in IMAT index as measured by MuscleSound Baseline to 3 month follow-up
Secondary Change in EQ-5D-5L Score Scores range from -0.59 to 1. 1 is the best possible health state. Negative values represent health states perceived as worse than death, which is equal to 0 Baseline to 6 month follow-up
Secondary 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
Secondary 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
Secondary Change in and Lawton Score Score ranges from 0 (very dependent) to 8 (high function, independent) Baseline to 6 month follow-up
Secondary Change in Katz Score Score ranges from 0 (very dependent) to 6 (independent) Baseline to 6 month follow-up
Secondary 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
Secondary 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
Secondary 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
Secondary Change in Cardiorespiratory fitness VO2P obtained during incremental Step Test Baseline to 3 month follow-up
Secondary 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
Secondary 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
Secondary Compare COST-FACIT score between intervention and control group Score ranges from 0 to 44, with a higher score indicating better financial well-being. 6 months
Secondary Compare COST-FACIT score between intervention and control group Score ranges from 0 to 44, with a higher score indicating better financial well-being. 3 months
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