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COVID-19REMM-HIIT-CoVNCT05218083

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

A study testing REmotely monitored, Mobile health supported Multidomain Rehabilitation Program with High Intensity Interval Training (REMM-HIIT) in people with COVID-19 and Critical Illness, run by Duke University at 5 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COVID-19, Critical Illness, ICU Acquired Weakness
What is being tested?
REmotely monitored, Mobile health supported Multidomain Rehabilitation Program with High Intensity Interval Training (REMM-HIIT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
5 sitesUnited States
Study dates
23 Feb 2023to 1 Apr 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Marjan Cobbaert, MPH contact

919-668-9740

marjan.cobbaert@duke.edu

5 sites in 1 country

United States5 sites, 5 recruiting

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

    Peter Morris, MD

    Recruiting

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43201

    Nathan Brummel, MD

    Recruiting

  • Duke University Health System

    Durham, North Carolina, 27710

    Amy Pastva, PT, PhD

    Recruiting

  • University of Kentucky

    Lexington, Kentucky, 40536

    Kirby Mayer, PT, DPT, PhD

    Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37203

    E Wesley Ely, MD

    Recruiting

Other trials in United States

About this study

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.

Read the 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.

Being tested
REmotely monitored, Mobile health supported Multidomain Rehabilitation Program with High Intensity Interval Training (REMM-HIIT)
Medical subject headings
COVID-19, Critical Illness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • REmotely monitored, Mobile health supported Multidomain Rehabilitation Program with High Intensity Interval Training (REMM-HIIT)Behavioural

    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.

Study groups in NCT05218083
Study groupRoleWhat they receive
REmotely Monitored, Mobile health supported Multidomain Rehabilitation Program with HIITExperimentalPatients will receive our REmotely monitored, Mobile health supported Multidomain Rehabilitation Program with High Intensity Interval Training Program (REMM-HIIT) with iWatch/iPhone.
Receives: Behavioral: REmotely monitored, Mobile health supported Multidomain Rehabilitation Program with High Intensity Interval Training (REMM-HIIT)
Exercise education without personalized sessions or feedbackNo interventionPatients will receive an exercise handout and iWatch/iPhone. Patients return home to exercise without personalized instruction and coaching.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in 6 minute walk distance

    distance walked in m

    Measured: Baseline to 3 month follow-up

Secondary outcomes (20)

  1. Change in Cardiorespiratory fitness

    VO2P obtained during incremental Step Test

    Measured: Baseline to 3 month follow-up

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

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

    Measured: Baseline to 3 month follow-up

  3. Change in 30-sec sit to stand score

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

    Measured: Baseline to 3 month follow-up

  4. Change in Fried Frailty Index Score

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

    Measured: Baseline to 3 month follow-up

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

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

    Measured: Baseline to 3 months follow-up

  6. Change in muscle mass obtained via MuscleSound

    Change in IMAT index as measured by MuscleSound

    Measured: Baseline to 3 month follow-up

  7. 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

    Measured: Baseline

  8. 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

    Measured: 3 month visit

  9. 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

    Measured: 6 month visit

  10. 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.

    Measured: Baseline

  11. 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.

    Measured: 3 months

  12. 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.

    Measured: 6 months

  13. Compare Lawton Score between intervention and control group

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

    Measured: Baseline

  14. Compare Lawton Score between intervention and control group

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

    Measured: 3 months

  15. Compare Lawton Score between intervention and control group

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

    Measured: 6 months

  16. 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

    Measured: Baseline

  17. 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

    Measured: 3 months

  18. 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

    Measured: 6 months

  19. 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.

    Measured: 3 months

  20. 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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2022
  2. Study start23 Feb 2023
  3. Primary completion1 Jan 2027 (estimated)
  4. Study completion1 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05218083
Sponsor's protocol ID
Pro00109644
Other IDs
1R01HD107103
Acronym
REMM-HIIT-CoV
Status last verified
May 2026
First submitted
6 Jan 2022
Last updated
28 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing REmotely monitored, Mobile health supported Multidomain Rehabilitation Program with High Intensity Interval Training (REMM-HIIT) in people with COVID-19 and Critical Illness, run by Duke University at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Marjan Cobbaert, MPH (919-668-9740, marjan.cobbaert@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in 6 minute walk distance (time frame: Baseline to 3 month follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05218083.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.

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