Remote High-Intensity Interval Training for COVID-19 Recovery

(REMM-HIIT-CoV Trial)

Recruiting at 4 trial locations

Overseen By Marjan Cobbaert, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Recent cardiac event, Unstable angina, Uncontrolled hypertension, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 3 months

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

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.

Is high-intensity interval training (HIIT) safe for humans?

Research shows that high-intensity interval training (HIIT) is generally safe for humans, with no acute injuries or serious cardiovascular events reported in studies. It has been used safely in various populations, including those with health conditions, and has shown high adherence rates. ^{1 2 3 4 5}

How is the REMM-HIIT-CoV treatment different from other COVID-19 recovery treatments?

The REMM-HIIT-CoV treatment is unique because it combines high-intensity interval training (HIIT) with remote monitoring and mobile health support, allowing patients to engage in a structured rehabilitation program from home. This approach is particularly beneficial for those who cannot access in-person rehabilitation services, offering a novel way to improve recovery and lung function after COVID-19. ^{2 4 5 6 7}

What data supports the effectiveness of the treatment REmotely Monitored, Mhealth supported High Intensity Interval Training for COVID-19 recovery?

Research shows that remote rehabilitation programs, like the COVIDREHAB platform, have been effective in improving lung function and reducing symptoms such as shortness of breath in COVID-19 patients. Additionally, a study on a respiratory telerehabilitation program found it to be effective, safe, and feasible for COVID-19 patients, suggesting that similar remote high-intensity interval training could also be beneficial. ^{4 5 7 8 9}

Who Is on the Research Team?

Paul Wischmeyer, MD

Principal Investigator

Duke Clinical Research Institute

Are You a Good Fit for This Trial?

This trial is for adults over 18 who were hospitalized with COVID-19 and can walk on their own or with a cane. They should be going home directly from the hospital, not to another care facility, and must be able to exercise and use an iPhone for mobile health coaching.

Inclusion Criteria

I will be going home directly after my hospital discharge.

I can walk by myself or with help like a cane before leaving the hospital.

I was hospitalized due to COVID-19.

Exclusion Criteria

I was not walking on my own before getting COVID-19, but I could use a walking aid.

I need home oxygen or can't exercise due to my health condition.

I do not have any health conditions that prevent me from exercising safely.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a remotely monitored, mobile health-supported high intensity interval rehabilitation exercise training program

3 months

Remote monitoring with iWatch/iPhone

Follow-up

Participants are monitored for changes in physical function, cognitive ability, muscle mass, and other health metrics

3 months

Extended Follow-up

Participants are monitored for long-term changes in health metrics such as EQ-5D-5L Score, Lawton Score, and biomarkers of aging and inflammation

6 months

What Are the Treatments Tested in This Trial?

Interventions

• REmotely Monitored, Mhealth supported High Intensity Interval Training
• REmotely Monitored, Mobile Health Supported Multidomain Rehabilitation Program with High Intensity Interval Training

Trial Overview The study tests a remote, mobile health-supported rehab program with high-intensity interval training (REMM-HIIT) in patients recovering from severe COVID-19. It's a randomized controlled trial involving 120 participants who complete at least one exercise session.

How Is the Trial Designed?

Group I: REmotely Monitored, Mobile health supported Multidomain Rehabilitation Program with HIIT Experimental Treatment 1 Intervention

Patients will receive our REmotely monitored, Mobile health supported Multidomain Rehabilitation Program with High Intensity Interval Training Program (REMM-HIIT) with iWatch/iPhone.

Group II: Exercise education without personalized sessions or feedback Active Control 1 Intervention

Patients will receive an exercise handout and iWatch/iPhone. Patients return home to exercise without personalized instruction and coaching.

REmotely Monitored, Mhealth supported High Intensity Interval Training is already approved in United States for the following indications:

Approved in United States as REMM-HIIT-CoV for:

• Rehabilitation after COVID-19 critical illness

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Florida Atlantic University

Collaborator

Trials

35

Recruited

10,700+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Vanderbilt University Medical Center

Collaborator

Trials

922

Recruited

939,000+

Ohio State University

Collaborator

Trials

891

Recruited

2,659,000+

University of Kentucky

Collaborator

Trials

198

Recruited

224,000+

University of Alabama at Birmingham

Collaborator

Trials

1,677

Recruited

2,458,000+

Published Research Related to This Trial

A telemedicine platform called 'COVIDREHAB' was developed and tested in a pilot study with 178 patients recovering from moderate COVID-19, showing that remote rehabilitation can effectively improve respiratory function and reduce symptoms like shortness of breath and feelings of lack of oxygen.

Patients who completed the COVIDREHAB program experienced significant improvements in their respiratory health, with shortness of breath severity decreasing from 34.8% to 12.4% and feelings of lack of oxygen from 32% to 17.4%, highlighting the efficacy of telemedicine in enhancing recovery during self-isolation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemedicine platform COVIDREHAB for remote rehabilitation of patients after COVID-19. Gilmutdinova, IR., Kolyshenkov, VA., Lapickaya, KA., et al.[2022]

A one-week telerehabilitation program focusing on breathing exercises significantly improved respiratory function in COVID-19 patients with mild to moderate symptoms, as shown by various tests including the Six-Minute Walk Test and the Thirty-Second Sit-To-Stand Test.

The program demonstrated high feasibility and safety, with a 90% adherence rate among participants, indicating that remote rehabilitation can be effectively implemented during the acute stage of COVID-19.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-Term Effects of a Respiratory Telerehabilitation Program in Confined COVID-19 Patients in the Acute Phase: A Pilot Study. Gonzalez-Gerez, JJ., Saavedra-Hernandez, M., Anarte-Lazo, E., et al.[2021]

A survey of current pulmonary rehabilitation (PR) service users revealed that 31% had never accessed the Internet, highlighting a significant barrier to remote PR delivery during the COVID-19 pandemic.

Only 48% of participants felt confident using the Internet, and 29% showed no interest in engaging with any online components of PR, indicating challenges in adopting web-based rehabilitation models.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital habits of PR service-users: Implications for home-based interventions during the COVID-19 pandemic. Polgar, O., Aljishi, M., Barker, RE., et al.[2020]

In a study of 61 patients with hypoxemic COVID-19, those who participated in early pulmonary rehabilitation (PR) had a significantly shorter duration of oxygen use compared to those who did not receive PR (P = .012).

PR not only reduced the time patients needed supplemental oxygen but also improved their quality of life, suggesting it is a safe and effective intervention for patients recovering from COVID-19.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Telerehabilitation for Coronavirus Disease 2019 Patients Discharged with Oxygen Shorten the Time of Weaning from Oxygen? Deniz, S., Yılmaz, C., Süneçli, O., et al.[2023]

Tele-pulmonary rehabilitation has emerged as a feasible and effective alternative to traditional in-person pulmonary rehabilitation for patients with chronic obstructive pulmonary disease (COPD), especially during the COVID-19 pandemic.

A hybrid model combining both in-person and remote components may be the best approach for delivering pulmonary rehabilitation in the future, but further high-quality studies and collaboration are needed to optimize this model.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary rehabilitation in a postcoronavirus disease 2019 world: feasibility, challenges, and solutions. Wen, J., Milne, S., Sin, DD.[2023]

High-intensity interval training (HIIT) has been shown to significantly improve various health outcomes, including cardiorespiratory fitness, muscle mass, and mental health indicators like anxiety and depression, across diverse populations, as evidenced by 33 systematic reviews involving both healthy individuals and those with health complications.

HIIT is considered safe, with no reported acute injuries and high adherence rates exceeding 80%, suggesting it is a feasible exercise option for many people.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can high-intensity interval training improve physical and mental health outcomes? A meta-review of 33 systematic reviews across the lifespan. Martland, R., Mondelli, V., Gaughran, F., et al.[2023]

This study is a randomized controlled trial involving 94 COVID-19 survivors, comparing high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT) over an 8-week period to assess their feasibility, safety, adherence, and effectiveness in improving health-related quality of life.

The trial aims to provide valuable insights into which exercise regimen may be more beneficial for post-COVID patients, potentially guiding clinical decisions for optimizing recovery and health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of High-Intensity Interval Training to Moderate-Intensity Continuous Training for Functioning and Quality of Life in Survivors of COVID-19 (COVIDEX): Protocol for a Randomized Controlled Trial. Gomes, VA., Fontoura, F., Saquetto, MB., et al.[2023]

The remote physical exercise program for stroke survivors had a high adherence rate of 86%, indicating that many participants were willing to engage with the program despite the challenges posed by remote delivery.

However, the actual attendance was low, with participants attending only 8 out of 44 sessions, primarily due to barriers like lack of motor skills and the absence of exercise companions, highlighting the need for tailored support in remote exercise programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence Rate, Barriers to Attend, Safety, and Overall Experience of a Remote Physical Exercise Program During the COVID-19 Pandemic for Individuals After Stroke. Torriani-Pasin, C., Palma, GCDS., Makhoul, MP., et al.[2021]

The RespiraConNosotros application provides guided respiratory rehabilitation exercises for COVID-19 patients, facilitating communication with physiotherapists through chat or video calls, which is crucial given the estimated 620,000 patients needing rehabilitation in Spain.

Participants using the app showed improvement in their respiratory function, as indicated by better scores on the Borg scale, highlighting its efficacy as a safe and accessible tool for enhancing pulmonary recovery post-COVID-19.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

RespiraConNosotros: A Viable Home-Based Telerehabilitation System for Respiratory Patients. Bermejo-Gil, BM., Pérez-Robledo, F., Llamas-Ramos, R., et al.[2021]

Citations

1. Italy pubmed.ncbi.nlm.nih.gov

Telemedicine platform COVIDREHAB for remote rehabilitation of patients after COVID-19. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Short-Term Effects of a Respiratory Telerehabilitation Program in Confined COVID-19 Patients in the Acute Phase: A Pilot Study. [2021]

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

Digital habits of PR service-users: Implications for home-based interventions during the COVID-19 pandemic. [2020]

4. Turkey pubmed.ncbi.nlm.nih.gov

Does Telerehabilitation for Coronavirus Disease 2019 Patients Discharged with Oxygen Shorten the Time of Weaning from Oxygen? [2023]

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

Pulmonary rehabilitation in a postcoronavirus disease 2019 world: feasibility, challenges, and solutions. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Can high-intensity interval training improve physical and mental health outcomes? A meta-review of 33 systematic reviews across the lifespan. [2023]

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

Comparison of High-Intensity Interval Training to Moderate-Intensity Continuous Training for Functioning and Quality of Life in Survivors of COVID-19 (COVIDEX): Protocol for a Randomized Controlled Trial. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Adherence Rate, Barriers to Attend, Safety, and Overall Experience of a Remote Physical Exercise Program During the COVID-19 Pandemic for Individuals After Stroke. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

RespiraConNosotros: A Viable Home-Based Telerehabilitation System for Respiratory Patients. [2021]