Optimizing Outcomes With Physical Therapy Treatment for IndividuALs Surviving an Intensive Care Units Admission for COVID-19 (OPTImAL)—A Protocol for a Single Center Prospective Study

Abstract

Purpose: Survivors of acute respiratory failure develop persistent muscle weakness and deficits in cardiopulmonary endurance leading to limited physical function. Early data from the COVID-19 pandemic suggest a high incidence of critically ill patients admitted to intensive care units (ICU) will require mechanical ventilation for acute respiratory failure. Patients with COVID-19 that survive an admission to the ICU are expected to suffer from physical and cognitive impairments that will limit quality of life and return to prehospital level of function. The primary aim of this study is to evaluate the safety and feasibility of providing combined ICU aftercare (ICU Recovery Clinic) and 8 weeks of physical therapy treatment for patients surviving an admission to ICU for COVID-19. The secondary aims will be to explore trends of effect on physical, mental, and cognitive recovery as well as the impact on return to work, readmission rates, and mortality. Methods: This is a protocol to describe a single-center, prospective phase I feasibility study in patients surviving ICU admission for COVID-19. We hypothesize that this novel combination is (1) feasible to provide for patients surviving COVID-19, will (2) improve physical function and exercise capacity measured by performance on 6-minute walk test and Short Performance Physical Battery, and (3) reduce incidence of anxiety, depression, and post-traumatic stress assessed with Hospital Anxiety and Depression Scale and the Impact of Events Scale-Revised. Safety will be assessed based on occurrence of adverse events and feasibility will be measured by adherence and attrition. Repeated measures analysis of variance will be used to assess change in outcomes from baseline to 3- and 6-months after institutional discharge. Results: We present the protocol of this study that has already received ethics approval at the University of Kentucky with enrollment commenced on May 1, 2020. Conclusions: The results of this study will support the feasibility of providing ICU follow-up treatment and physical therapy treatment for patients surviving critical illness for COVID-19 and will assess the effectiveness. We plan to disseminate study results in peer-reviewed journals as well as presentation at physical therapy and critical care national and international conferences.

Safety and Feasibility of an Interdisciplinary Treatment Approach to Optimize Recovery From Critical Coronavirus Disease 2019

“…The University of Kentucky ICU Recovery Clinic was established in 2012 and consists of an interdisciplinary team with expertise in critical illness recovery ( 14 ). Due to high potential for long-term impairments in COVID-19 survivors, the U.K. ICU Recovery Clinic team formulated a multimodal treatment program in the March of 2020 ( 18 ). Prior to February 2020, the ICU Recovery Clinic performed multidisciplinary assessments and referred patients in need to both rehabilitation specialist within our healthcare system and external providers.…”

“…The study was a phase I feasibility study using a pragmatic, pre-post design with patients self-selecting enrollment into one of the two recovery pathways: in-person versus telehealth. The study was registered in ClinicalTrials.gov (NCT04412330), and the protocol was previously published ( 18 ).…”

“…Adult patients (greater than or equal to 18 yr old) surviving an ICU admission for critical COVID-19 (laboratory-confirmed) and attending the ICU Recovery Clinic for interdisciplinary follow-up were eligible. More detailed eligibility criteria are outlined in the protocol ( 18 ). Patients were recruited at hospital discharge or during the patients’ first ICU Recovery Clinic appointment (occurring ~2- to 4-wk posthospital discharge), where they underwent a full medical assessment to confirm appropriateness for physical rehabilitation.…”

“…The interventions are described in brief below ( 18 ). The ICU Recovery Clinic and the outpatient rehabilitation center are housed in the same outpatient center and share common spaces.…”

“…Mindfulness techniques focused on components of mediation and guided imaginary ( 23 ). Breathing and mindfulness techniques were added to the program as a modification to original protocol during the first week of study enrollment; thus, all patients engaged in breathing and mindfulness techniques ( 18 ).…”