The National Institutes of Health’s Eunice Kennedy Shriver National Institute of Child Health and Human Development has awarded Duke Anesthesiology’s Paul Wischmeyer, MD, EDIC, FASPEN, FCCM, a five-year, $4,059,863 R01 grant for his project titled, “Remotely Monitored, Mobile Health-Supported High Intensity Interval Training After COVID-19 Critical Illness (REMM HIIT-Covid19).”
This trial utilizes high-level exercise testing, like that used by Olympic athletes, at hospital discharge in COVID-19 ICU survivors to personalize and target home exercise goals to promote recovery of physical function, exercise tolerance and quality of life. This program is unique and innovative as it allows personalized high intensity training exercise to be performed in patients at home while they are monitored remotely by physical therapists via IWatch and IPhone mobile device technology. This allows coaching and adaptation of exercise performance directly by physical therapists on a daily basis. The trial will be conducted at four leading US Academic ICU centers including Duke, Vanderbilt (co-site PIs: Drs. Wes Ely and Matthew Mart), University of Kentucky (site-PI: Dr. Peter Morris), and Ohio State University (site PI: Dr. Nathan Brummel).
This trial is critically and urgently needed as severe disease from COVID-19 continues to require hospitalization in 20 percent of adults, with a third of those patients requiring intensive care unit (ICU) treatment. While a growing number of patients are surviving COVID-19 critical illness, like other ICU survivors, the majority will experience significant post-hospital disabilities in physical function and exercise capacity, new-onset disability, muscle wasting/weakness, and new cognitive deficits. These difficulties, which can persist for months to years post-ICU, are collectively known as post-intensive care syndrome (PICS) and may be more severe in COVID-19 survivors.
The National Center for Medical Rehabilitation Research has deemed “research to address the rehabilitation needs of severe COVID-19 survivors…via new clinical trials of home-based rehabilitation interventions…with emphasis on use of mobile or digital devices” a priority area of research. In alignment with those priorities and the urgent public health need created by COVID-19 to overcome challenges to traditional rehabilitation strategies, Wischmeyer and co-PI Dr. Amy Pastva (PhD physical therapist) of Duke Orthopaedic Surgery will assess a successfully piloted novel home rehabilitation program to improve recovery of cardiorespiratory fitness (CRF) and physical function in COVID-19 ICU survivors – specifically, survivors who frequently experience PICS.
The unique strengths of this randomized trial include a home-based innovative, tailored, structured, and progressive multidomain rehabilitation strategy, scientifically rigorous clinical trial design, an inter-disciplinary research team, access to a large COVID-19 ICU patient pool, innovative mobile health device platform, statistical power, patient safety, and inclusion of CRF performance-based, as well as patient-reported post-hospital outcomes. The key to the approach of this trial is Wischmeyer and Pastva’s mHealth platform, in which patients are given Apple watches and iPhones preloaded with their software allowing them to remotely download data after each exercise session to provide personalized up-coaching via videoconferencing in a home setting. This novel home exercise concept has been successfully piloted at Duke in cancer patients preparing for bone marrow transplant by Dr. Tony Sung and his team; Sung will serve as key co-investigator on this new RO1 with Wischmeyer.
Previous studies of home-based physical rehabilitation in ICU survivors have utilized unsupervised exercise training without a personalized exercise prescription, and none have done so while actively monitoring and targeting exercise via physiologic data such as heart rate or included strength and balance training. To address this gap in knowledge, the investigators will randomize 140 COVID-19 ICU survivors being discharged home to their study to test the hypothesis that the REMM-HIIT exercise intervention, in contrast to exercise education alone, will improve CRF and muscle strength/mass and improve physical function and quality of life.
Wischmeyer says, “We hope this study of post-ICU personalized high-intensity interval exercise training will lead to more ICU survivors from COVID-19 and other ICU illness who are able to return to active, productive lives versus ‘ICU victims’ who often suffer long term disabilities that can persist for years after an ICU admission.”