Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05218083

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in 6 minute walk distance

    Time frame: Baseline to 3 month follow-up

    distance walked in m

Secondary outcomes

  1. Change in Cardiorespiratory fitness

    Time frame: Baseline to 3 month follow-up

    VO2P obtained during incremental Step Test

  2. Change in physical function measured by Short Physical Performance Battery (SPPB) score.

    Time frame: Baseline to 3 month follow-up

    Scores range from 0 (frailty) to 12 (robustness).

  3. Change in 30-sec sit to stand score

    Time frame: Baseline to 3 month follow-up

    Number of times the patient comes to a full standing position in 30 seconds

  4. Change in Fried Frailty Index Score

    Time frame: Baseline to 3 month follow-up

    Score ranges from 0 (not frail) to 5 (frail).

  5. Change in cognitive ability as measured by the MoCA Test

    Time frame: Baseline to 3 months follow-up

    Scores range from 0 to 30 with a lower score indicating more cognitive impairment.

  6. Change in muscle mass obtained via MuscleSound

    Time frame: Baseline to 3 month follow-up

    Change in IMAT index as measured by MuscleSound

  7. Compare EQ-5D-5L Score between intervention and control group

    Time frame: Baseline

    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

  8. Compare EQ-5D-5L Score between intervention and control group

    Time frame: 3 month visit

    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

  9. Compare EQ-5D-5L Score between intervention and control group

    Time frame: 6 month visit

    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

  10. Compare Duke Activity Status Index (DASI) Score between intervention and control group

    Time frame: Baseline

    DASI scores range from 0 to 58.2, with a higher score indicating higher functional capacity.

  11. Compare Duke Activity Status Index (DASI) Score between intervention and control group

    Time frame: 3 months

    DASI scores range from 0 to 58.2, with a higher score indicating higher functional capacity.

  12. Compare Duke Activity Status Index (DASI) Score between intervention and control group

    Time frame: 6 months

    DASI scores range from 0 to 58.2, with a higher score indicating higher functional capacity.

  13. Compare Lawton Score between intervention and control group

    Time frame: Baseline

    Score ranges from 0 (very dependent) to 8 (high function, independent)

  14. Compare Lawton Score between intervention and control group

    Time frame: 3 months

    Score ranges from 0 (very dependent) to 8 (high function, independent)

  15. Compare Lawton Score between intervention and control group

    Time frame: 6 months

    Score ranges from 0 (very dependent) to 8 (high function, independent)

  16. Compare Hospital Anxiety and Depression Scale (HADS) Score between intervention and control group

    Time frame: Baseline

    Scores ranges from 0 to 21 for both anxiety and depression, with a higher score indicating more symptoms of depression or anxiety

  17. Compare Hospital Anxiety and Depression Scale (HADS) Score between intervention and control group

    Time frame: 3 months

    Scores ranges from 0 to 21 for both anxiety and depression, with a higher score indicating more symptoms of depression or anxiety

  18. Compare Hospital Anxiety and Depression Scale (HADS) Score between intervention and control group

    Time frame: 6 months

    Scores ranges from 0 to 21 for both anxiety and depression, with a higher score indicating more symptoms of depression or anxiety

  19. Compare social determinants of health between intervention and control group

    Time frame: 3 months

    Completion of the Accountable Health Communities Health-Related Social Needs Screening Tool. A higher score indicates a higher Health-related social need.

  20. Compare social determinants of health between intervention and control group

    Time frame: 6 months

    Completion of the Accountable Health Communities Health-Related Social Needs Screening Tool. A higher score indicates a higher Health-related social need.

Study contacts

Contact information is provided by the study sponsor or research team.

Marjan Cobbaert, MPH

CONTACT

[email protected]

919-668-9740

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • 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

Registry information

Acronym: REMM-HIIT-CoV

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Feb 1, 2022
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.