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?

This trial tests whether remotely conducted high-intensity interval training (HIIT) can enhance recovery for individuals critically ill with COVID-19. Participants will either receive a personalized exercise program with feedback via a mobile device or exercise guidelines without personalized support. It targets those who were hospitalized due to COVID-19, are now home, and could walk independently before illness. The study aims to determine if guided, tech-supported exercise improves recovery compared to standard exercise advice. As an unphased trial, it offers a unique opportunity to contribute to innovative recovery methods that could benefit future patients.

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.

What prior data suggests that this protocol is safe for COVID-19 recovery?

Research shows that the REmotely Monitored, Mobile Health-supported High Intensity Interval Training (REMM-HIIT) is generally easy for participants to handle. In past studies, many adhered well to the exercise plan, with some even exceeding the recommended sessions. Nearly all participants met their heart rate targets, achieving a success rate of 98%. This indicates that most people can perform the exercises without major issues.

No specific reports of serious side effects or negative events appear in the available data. Mobile health support helps participants stay within safe exercise limits. However, like any physical activity, there is a small risk of strain or injury, so following the guidelines and paying attention to body signals is important.

Overall, research suggests that this exercise program is safe for those recovering from severe COVID-19 illness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the remote high-intensity interval training (HIIT) for COVID-19 recovery because it offers a novel approach by integrating technology and exercise. Unlike traditional rehabilitation methods that often require in-person sessions, this program allows patients to engage in high-intensity workouts from their homes, with support and monitoring via mobile health technology like iWatch or iPhone. This remote aspect can increase accessibility and convenience, potentially helping more people recover faster by maintaining consistent exercise routines. Additionally, the multidomain rehabilitation program aims to address various aspects of recovery, providing a more comprehensive approach compared to standard exercise education alone.

What evidence suggests that this trial's treatments could be effective for COVID-19 recovery?

Research has shown that high-intensity interval training (HIIT), monitored remotely through mobile health tools, can significantly aid COVID-19 patients in recovery. In this trial, some participants will receive the REmotely Monitored, Mobile Health Supported Multidomain Rehabilitation Program with HIIT. Studies have found that patients in this exercise program improve their heart and lung function, as well as their overall physical abilities. Participants demonstrated strong commitment, often completing more sessions than required and meeting their heart rate targets. Early results suggest that mobile health tools can effectively enhance health outcomes after severe COVID-19. These findings are promising for improving recovery and quality of life for those recovering from serious COVID-19 illness. ^{1 2 5 6 7}

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pandemicpact.org pandemicpact.org/grants/P37375

Remotely Monitored, Mobile health-supported High ... Adherence to exercise was 117% (meaning patients exercised more than recommended 3 sessions/week), compliance with heart rate goals was 98% (meaning patients ...

2. 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 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06953648

Remotely Monitored, Mobile Health-supported, High ... The investigators hypothesize that patients undergoing REMM-HIIT program will experience improved CRF, physical function, and QOL pre-HCT, leading to better ...

4. reporter.nih.gov reporter.nih.gov/search/y6F-l-F5ZUyx_jkN_TOG5w/project-details/10688052

Project Details - NIH RePORTER Adherence to exercise was 117% (meaning patients exercised more than recommended 3 sessions/week), compliance with heart rate goals was 98% (meaning patients ...

5. 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) | IRAD Research Portfolio.

6. pandemicpact.org pandemicpact.org/grants/P40183

Remotely Monitored, Mobile health-supported High ... Adherence to exercise was 117% (meaning patients exercised more than recommended 3 sessions/week), compliance with heart rate goals was 98% (meaning patients ...

7. ctv.veeva.com ctv.veeva.com/study/remotely-monitored-mobile-health-supported-multidomain-rehabilitation-program-with-high-intensity-i

REmotely Monitored, Mobile Health Supported Multidomain ... Patients will receive our REmotely monitored, Mobile health supported Multidomain Rehabilitation Program with High Intensity Interval Training ...