REmotely Monitored, Mobile Health Supported Multidomain Rehabilitation Program With High Intensity Interval Training for COVID-19 (REMM-HIIT-CoV)

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.

Study Overview

• Status: Recruiting
• Conditions: COVID-19; Critical Illness; ICU Acquired Weakness; Cardiorespiratory Fitness; PICS
• Intervention / Treatment: Behavioral: REmotely monitored, Mobile health supported Multidomain Rehabilitation Program with High Intensity Interval Training (REMM-HIIT)

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marjan Cobbaert, MPH; Phone Number: 919-668-9740; Email: marjan.cobbaert@duke.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Recruiting
      • University of Alabama at Birmingham
      • Contact: Peter Morris, MD
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • Recruiting
      • University Of Kentucky
      • Contact: Kirby Mayer, PT, DPT, PhD
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke University Health System
      • Contact: Amy Pastva, PT, PhD
  • Ohio
    • Columbus, Ohio, United States, 43201
      • Recruiting
      • The Ohio State University Wexner Medical Center
      • Contact: Nathan Brummel, MD
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • Vanderbilt University Medical Center
      • Contact: E Wesley Ely, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 6 minute walk distance	distance walked in m	Baseline to 3 month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Cardiorespiratory fitness	VO2P obtained during incremental Step Test	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 muscle mass obtained via MuscleSound	Change in IMAT index as measured by MuscleSound	Baseline to 3 month follow-up
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in mitochondrial function	blood collection	Baseline and 6 months post-hospital discharge
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
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
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

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); University of Alabama at Birmingham; Vanderbilt University Medical Center; Ohio State University; University of Kentucky; Florida Atlantic University
• Investigators: Principal Investigator: Paul Wischmeyer, MD, Duke Clinical Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: January 6, 2022
• First Submitted That Met QC Criteria: January 31, 2022
• First Posted (Actual): February 1, 2022

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Pathological Conditions, Signs and Symptoms; COVID-19; Critical Illness; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Physical Conditioning, Human; Exercise; High-Intensity Interval Training
• Other Study ID Numbers: Pro00109644; 1R01HD107103 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No