REMM-HIIT for Post-COVID-19 Critical Illness

(REMMHIIT-COVID Trial)

No longer recruiting at 1 trial location

Overseen By Alice Szydlowska

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Recent cardiac event, Unstable angina, Uncontrolled dysrhythmias, Symptomatic aortic stenosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a workout program designed to aid recovery from severe COVID-19. It employs a high-intensity interval training (HIIT) routine that participants can perform at home, with support from remote monitoring and coaching via a mobile app. The researchers aim to determine if this approach improves strength, balance, and mobility after a serious illness. Individuals who have been in the ICU due to COVID-19, can walk independently, and are going home directly from the hospital may be suitable candidates for this trial. The trial will compare participants receiving personalized coaching with those using the same app without direct feedback. As an unphased trial, it offers a unique opportunity to contribute to innovative recovery methods that could benefit many others.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this high intensity interval training protocol is safe for post-COVID-19 critical illness recovery?

Research has shown that high-intensity interval training (HIIT), when monitored remotely with mobile health tools, is generally safe for participants. Studies on older adults with health issues indicate that HIIT is well-tolerated and can lead to noticeable improvements in just a few weeks, making the exercise program manageable even for those with existing health challenges.

Importantly, studies involving HIIT report that unwanted side effects are rare. Participants use activity trackers, enabling health professionals to monitor heart rates and provide personalized advice. This remote monitoring ensures the exercise is safe and tailored to each person's needs.

Overall, HIIT with remote support appears to be a safe and effective way to regain fitness, even after serious illnesses like COVID-19. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the REMM-HIIT treatment because it offers a unique approach to recovering from post-COVID-19 critical illness. Unlike traditional rehabilitation methods that might not provide real-time feedback, this method uses remotely monitored, high-intensity interval training (HIIT) supported by mobile health technology. This setup allows for personalized coaching based on heart rate data, potentially improving exercise effectiveness and patient motivation. By combining high-intensity workouts with tailored feedback, researchers hope to enhance recovery faster and more effectively than standard self-directed exercise regimens.

What evidence suggests that REMM-HIIT is effective for post-COVID-19 critical illness?

Research has shown that high-intensity interval training (HIIT) can greatly aid COVID-19 ICU survivors in their recovery. Studies have found that HIIT enhances physical ability and overall fitness, crucial for those recovering from serious illnesses. In this trial, one group of participants will engage in HIIT monitored remotely through mobile health technology, receiving personalized feedback and coaching. This support maintains motivation and ensures safe and effective exercise. Early results suggest that this structured and supported exercise program can lead to better health outcomes compared to exercising without guidance, which participants in the comparator group will experience. ^{1 4 5 6 7}

Who Is on the Research Team?

Paul Wischmeyer, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

Inclusion Criteria

ICU admission and subsequent discharge for primary diagnosis of COVID-19 respiratory failure or infection requiring intubation and mechanical ventilation for > 48 hours with an ICU length of stay of ≥ 4 days

Ability to ambulate with or without a gait aid prior to hospital discharge

Expected hospital discharge directly back to patient's residence (not to a skilled nursing facility, inpatient rehabilitation center, or long-term acute care hospital)

Exclusion Criteria

Not ambulating independently prior to COVID-19 illness (use of a gait aid permitted)

Functional impairment resulting in inability to exercise at hospital discharge (including need for home oxygen requirement)

Unable or unwilling to follow coaching via mobile-health iPhone interaction

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in remotely monitored, mobile health-supported high intensity interval training (HIIT) 3 times a week, supplemented with strength, balance, and mobility exercises 2 times a week.

12 weeks

Remote monitoring with daily feedback

Follow-up

Participants are monitored for changes in biomarkers, physical performance, and cognitive function post-treatment.

3 months

Remote assessments at 3 months post-discharge

Extended Follow-up

Participants' cognitive function and quality of life are assessed from 3 to 6 months post-discharge.

3 months

Remote assessments at 6 months post-discharge

What Are the Treatments Tested in This Trial?

Interventions

• REMotely Monitored, Mobile Health-Supported High Intensity Interval Training

How Is the Trial Designed?

Group I: REmotely Monitored, Mhealth (REMM) supported High Intensity Interval Training (HIIT) Experimental Treatment 1 Intervention

REmotely Monitored, Mhealth (REMM) supported High Intensity Interval Training (HIIT) The intervention consists of high intensity interval training, consisting of a 30-minute exercise session that includes 10 x 1-minute intervals of high intensity 3x/week (e.g., Monday, Wednesday, Friday) and supplemented with 2 sessions per week of strength, balance, and mobility exercises (e.g., Tuesday, Thursday). Exercise will be supported by an activity tracker, which will allow study personnel to track patient heart rates during exercise on a daily basis, allowing them to provide individualized feedback and coaching.

Group II: Comparator Experimental Treatment 1 Intervention

Patients randomized to the control arm will receive the same technology platform and education on exercise options, including HIIT, but will return home to exercise as they see fit without personalized instruction and coaching. They will be remotely monitored, but will not receive feedback unless any adverse events are noted

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Vanderbilt University

Collaborator

Trials

714

Recruited

6,143,000+

Published Research Related to This Trial

A study involving 90 patients with severe respiratory failure showed that implementing an early exercise safety management program during mechanical ventilation significantly improved mental health, lung function, and overall quality of life compared to standard care.

The early exercise program also resulted in a lower incidence of complications (24.44% vs. 57.78%), highlighting its safety and effectiveness in the ICU setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Application of early exercise safety management in patients undergoing mechanical ventilation in intensive care unit]. Zhang, L., Yan, R., Zhou, Y., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04664101

Study Details | NCT04664101 | REmotely Monitored, ... A remotely monitored, Mhealth-supported high intensity interval rehabilitation exercise training to improve the functional recovery of survivors who have ...

2. irad.nih.gov irad.nih.gov/project/remotely-monitored-mobile-health-supported-high-intensity-interval-training-after-covid-0

Remotely Monitored, Mobile health-supported High Intensity ... Remotely Monitored, Mobile health-supported High Intensity Interval Training after COVID-19 Critical Illness (REMM HIIT-Covid19) ... Data provided by NIH for this ...

3. pandemicpact.org pandemicpact.org/grants/P37375

Remotely Monitored, Mobile health-supported High ... To address this gap in knowledge, we will randomize 140 COVID-19 ICU survivors being discharged home to our REmotely Monitored, Mobile health-supported High ...

4. scholars.uky.edu scholars.uky.edu/en/projects/covid-19-remotely-monitored-mobile-health-supported-high-intensit-4

Covid 19: Remotely Monitored, Mobile Health-Supported High ... ... REmotely monitored, Mobile health supported Multidomain rehabilitation program with High Intensity Interval Training for COVID-19 (REMM-HIIT-COVID19) study.

5. withpower.com withpower.com/trial/phase-covid-19-9-2021-9976e

REMM-HIIT for Post-COVID-19 Critical Illness This trial uses technology to remotely monitor and support high-intensity exercise for COVID-19 survivors. The goal is to help these patients rebuild their ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06953648

Remotely Monitored, Mobile Health-supported, High ... The goal of this clinical trial is to learn how a remotely monitored high-intensity interval training (REMM-HIIT) affects the cardiorespiratory fitness and ...

7. reporter.nih.gov reporter.nih.gov/search/jO6GJ_twoES5SfhjTclHxw/project-details/10688052

Project Details In debilitated older patients, high intensity interval training (HIIT) is safe and associated with significant improvements (in as little as two weeks) in ...