REMM-HIIT for Post-COVID-19 Critical Illness

(REMMHIIT-COVID Trial)

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

13 Participants Needed

Trial Summary

What is the purpose of this trial?

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 strength and fitness through short bursts of intense exercise.

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 data supports the effectiveness of the treatment REMM-HIIT for Post-COVID-19 Critical Illness?

Research shows that early rehabilitation and exercise, like cycling and muscle stimulation, can improve recovery and physical function in critically ill patients, suggesting that high-intensity interval training could be beneficial for post-COVID-19 recovery. ^{1 2 3 4 5}

Is REMM-HIIT safe for humans?

Research on similar exercise programs for critically ill patients suggests that supervised exercise, even early on, is generally safe and can improve physical fitness and quality of life after hospital discharge. ^{1 4 6 7 8}

How is the REMM-HIIT treatment different from other treatments for post-COVID-19 critical illness?

REMM-HIIT is unique because it combines high-intensity interval training with remote monitoring and mobile health support, allowing patients to exercise safely at home while being supervised digitally. This approach is novel compared to traditional rehabilitation methods, which often require in-person sessions and may not utilize technology for remote monitoring. ^{4 5 6 9 10}

Research Team

Paul Wischmeyer, MD

Principal Investigator

Duke University

Eligibility Criteria

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

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

Treatment Details

Interventions

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

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Effect of supervised aerobic exercise rehabilitation on physical fitness and quality-of-life in survivors of critical illness: an exploratory minimized controlled trial (PIX study). [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Muscle mass and physical recovery in ICU: innovations for targeting of nutrition and exercise. [2021]

3. England pubmed.ncbi.nlm.nih.gov

The impact of early rehabilitation in intensive care unit for COVID-19 patients. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Very early passive cycling exercise in mechanically ventilated critically ill patients: physiological and safety aspects--a case series. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Effect of In-Bed Leg Cycling and Electrical Stimulation of the Quadriceps on Global Muscle Strength in Critically Ill Adults: A Randomized Clinical Trial. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Detailed characterization of a long-term rodent model of critical illness and recovery. [2021]

7. China pubmed.ncbi.nlm.nih.gov

[Application of early exercise safety management in patients undergoing mechanical ventilation in intensive care unit]. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Supervised exercise rehabilitation in survivors of critical illness: A randomised controlled trial. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Digitally enhanced recovery from severe COVID-19: a new frontier? [2021]

10. England pubmed.ncbi.nlm.nih.gov

A repeated measures, randomised cross-over trial, comparing the acute exercise response between passive and active sitting in critically ill patients. [2022]