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

COVID-19 Clinical Trial

— REMM-HIIT-CoV  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05218083
• Other study ID #: Pro00109644
• Secondary ID: 1R01HD107103
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Cardiorespiratory Fitness
• COVID-19
• Critical Illness
• ICU Acquired Weakness
• PICS

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