120 Participants Needed

Remote High-Intensity Interval Training for COVID-19 Recovery

(REMM-HIIT-CoV Trial)

Recruiting at 4 trial locations
MC
Overseen ByMarjan Cobbaert, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Duke University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 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.12345

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.12678

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-19.12479

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.

Research Team

PW

Paul Wischmeyer, MD

Principal Investigator

Duke Clinical Research Institute

Eligibility Criteria

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.
See 2 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: REmotely Monitored, Mobile health supported Multidomain Rehabilitation Program with HIITExperimental Treatment1 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 feedbackActive Control1 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

Find a Clinic Near You

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+

Findings from Research

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.
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.
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.
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]

References

Telemedicine platform COVIDREHAB for remote rehabilitation of patients after COVID-19. [2022]
Short-Term Effects of a Respiratory Telerehabilitation Program in Confined COVID-19 Patients in the Acute Phase: A Pilot Study. [2021]
Digital habits of PR service-users: Implications for home-based interventions during the COVID-19 pandemic. [2020]
Does Telerehabilitation for Coronavirus Disease 2019 Patients Discharged with Oxygen Shorten the Time of Weaning from Oxygen? [2023]
Pulmonary rehabilitation in a postcoronavirus disease 2019 world: feasibility, challenges, and solutions. [2023]
Can high-intensity interval training improve physical and mental health outcomes? A meta-review of 33 systematic reviews across the lifespan. [2023]
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]
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]
RespiraConNosotros: A Viable Home-Based Telerehabilitation System for Respiratory Patients. [2021]
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