R01HD107103

Remotely Monitored, Mobile Health-Supported High Intensity Interval Training After COVID-19 Critical Illness (REMM HIIT-COVID19) - Severe disease from COVID-19 requires hospitalization in 20% 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.

Despite literature demonstrating the benefit of physical rehabilitation in COVID-19 and other ICU survivors, there are limited available options and data to support an optimal post-hospital physical rehabilitation strategy. Combined with the difficulties of delivering rehabilitation in-person after hospitalization during a pandemic, addressing this "rehabilitation pandemic" from COVID-19 represents an enormous public health challenge.

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.

In debilitated older patients, high intensity interval training (HIIT) is safe and associated with significant improvements (in as little as two weeks) in cardiorespiratory fitness (CRF) that also correlates with self-reported physical function and disability. We have evaluated this approach in a successful NIH-funded phase 1 pilot study demonstrating safety and feasibility of HIIT in debilitated older adults with cancer. Adherence to exercise was 117% (meaning patients exercised more than recommended 3 sessions/week), compliance with heart rate goals was 98% (meaning patients were actually doing HIIT vs. less-intensive exercise), and on average patients improved CRF, as measured by VO2peak on cardiopulmonary exercise testing by 25%.

The key to our approach is our mHealth platform, in which patients are given Apple Watches and iPhones preloaded with our software allowing us to remotely download data after each exercise session to provide personalized up-coaching via videoconferencing in home setting.

As critical illness survivors, including COVID-19 ICU survivors, have impaired CRF (similar to patients in pilot study) and other manifestations of PICS, a similar monitored, personalized, structured, and progressive multi-domain physical rehabilitation intervention has significant potential for improving recovery, but has not yet been studied in COVID-19 survivors.

To address this gap in knowledge, we will randomize 140 COVID-19 ICU survivors being discharged home to our remotely monitored, mobile health-supported high intensity interval training after COVID-19 critical illness (REMM-HIIT-COVID-19) study to test the hypothesis that the REMM-HIIT exercise intervention, in contrast to exercise education alone, will improve CRF and muscle strength/mass (Aim 1); improve physical function and quality of life (Aim 2); and improve markers of mitochondrial function and inflammation (Aim 3) measured at 3-months after discharge.

Duke University

TO CONDUCT AND SUPPORT LABORATORY RESEARCH, CLINICAL TRIALS, AND STUDIES WITH PEOPLE THAT EXPLORE HEALTH PROCESSES. NICHD RESEARCHERS EXAMINE GROWTH AND DEVELOPMENT, BIOLOGIC AND REPRODUCTIVE FUNCTIONS, BEHAVIOR PATTERNS, AND POPULATION DYNAMICS TO PROTECT AND MAINTAIN THE HEALTH OF ALL PEOPLE. TO EXAMINE THE IMPACT OF DISABILITIES, DISEASES, AND DEFECTS ON THE LIVES OF INDIVIDUALS. WITH THIS INFORMATION, THE NICHD HOPES TO RESTORE, INCREASE, AND MAXIMIZE THE CAPABILITIES OF PEOPLE AFFECTED BY DISEASE AND INJURY. TO SPONSOR TRAINING PROGRAMS FOR SCIENTISTS, DOCTORS, AND RESEARCHERS TO ENSURE THAT NICHD RESEARCH CAN CONTINUE. BY TRAINING THESE PROFESSIONALS IN THE LATEST RESEARCH METHODS AND TECHNOLOGIES, THE NICHD WILL BE ABLE TO CONDUCT ITS RESEARCH AND MAKE HEALTH RESEARCH PROGRESS UNTIL ALL CHILDREN, ADULTS, FAMILIES, AND POPULATIONS ENJOY GOOD HEALTH. THE MISSION OF THE NICHD IS TO ENSURE THAT EVERY PERSON IS BORN HEALTHY AND WANTED, THAT WOMEN SUFFER NO HARMFUL EFFECTS FROM REPRODUCTIVE PROCESSES, AND THAT ALL CHILDREN HAVE THE CHANCE TO ACHIEVE THEIR FULL POTENTIAL FOR HEALTHY AND PRODUCTIVE LIVES, FREE FROM DISEASE OR DISABILITY, AND TO ENSURE THE HEALTH, PRODUCTIVITY, INDEPENDENCE, AND WELL-BEING OF ALL PEOPLE THROUGH OPTIMAL REHABILITATION.

93.865 - Child Health and Human Development Extramural Research

National Institute of Child Health and Human Development (NICHD) [HHS - NIH]

Durham, North Carolina 277054640 United States

Single Zip Code

NICHD Research Project Grant (R01 - Clinical Trial Required) (PA-18-480)

Amendment Since initial award the End Date has been extended from 08/31/26 to 08/31/27 and the total obligations have increased 258% from $920,165 to $3,292,532.