COVID-19 Clinical Trial
— REMM-HIIT-CoVOfficial title:
REmotely Monitored, Mobile Health Supported Multidomain Rehabilitation Program With High Intensity Interval Training for COVID-19
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.
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 |
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 |
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 |
United States,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
NCT06065033 -
Exercise Interventions in Post-acute Sequelae of Covid-19
|
N/A | |
Completed |
NCT06267534 -
Mindfulness-based Mobile Applications Program
|
N/A | |
Completed |
NCT05047601 -
A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection
|
Phase 2/Phase 3 | |
Recruiting |
NCT04481633 -
Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection
|
N/A | |
Recruiting |
NCT05323760 -
Functional Capacity in Patients Post Mild COVID-19
|
N/A | |
Completed |
NCT04612972 -
Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) to Prevent COVID-19 in Healthy Adult Population In Peru Healthy Adult Population In Peru
|
Phase 3 | |
Completed |
NCT04537949 -
A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults
|
Phase 1/Phase 2 | |
Recruiting |
NCT05494424 -
Cognitive Rehabilitation in Post-COVID-19 Condition
|
N/A | |
Active, not recruiting |
NCT06039449 -
A Study to Investigate the Prevention of COVID-19 withVYD222 in Adults With Immune Compromise and in Participants Aged 12 Years or Older Who Are at Risk of Exposure to SARS-CoV-2
|
Phase 3 | |
Enrolling by invitation |
NCT05589376 -
You and Me Healthy
|
||
Completed |
NCT05158816 -
Extracorporal Membrane Oxygenation for Critically Ill Patients With COVID-19
|
||
Recruiting |
NCT04341506 -
Non-contact ECG Sensor System for COVID19
|
||
Completed |
NCT04512079 -
FREEDOM COVID-19 Anticoagulation Strategy
|
Phase 4 | |
Completed |
NCT04384445 -
Zofin (Organicell Flow) for Patients With COVID-19
|
Phase 1/Phase 2 | |
Completed |
NCT05975060 -
A Study to Evaluate the Safety and Immunogenicity of an (Omicron Subvariant) COVID-19 Vaccine Booster Dose in Previously Vaccinated Participants and Unvaccinated Participants.
|
Phase 2/Phase 3 | |
Active, not recruiting |
NCT05542862 -
Booster Study of SpikoGen COVID-19 Vaccine
|
Phase 3 | |
Terminated |
NCT05487040 -
A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease
|
Phase 1 | |
Withdrawn |
NCT05621967 -
Phonation Therapy to Improve Symptoms and Lung Physiology in Patients Referred for Pulmonary Rehabilitation
|
N/A | |
Terminated |
NCT04498273 -
COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80
|
Phase 3 | |
Active, not recruiting |
NCT06033560 -
The Effect of Non-invasive Respiratory Support on Outcome and Its Risks in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2)-Related Hypoxemic Respiratory Failure
|