Zusammenfassung

Abstract Objectives The primary objective of the presented study is to analyze the respiratory and functional effects of a rehabilitation program in patients affected by hospitalization in Intensive Care Unit (ICU) due to COVID-19, in comparison with the group treated with standard of care, at discharge endpoint. The secondary objectives of the presented study are to evaluate different outcomes of the rehabilitation program in comparison to standard of care regarding: functional performance at 4-week and 12-week post- discharge mark; health-related quality of life, the impact on the health services (namely days of hospitalization), the cost-effectiveness of the intervention proposed. Trial design This is a randomized, controlled, double-blind, double-arm clinical trial of treatment, with an allocation ratio 1:1 and framework of superiority. Participants The study will be conducted at Centro Hospitalar Entre Douro e Vouga, Santa Maria da Feira, Portugal. Potential participants will be adult patients (≥18 years old) hospitalized in ICU with respiratory insufficiency due to COVID-19, who are referred to respiratory and functional rehabilitation. Only patients approved by physical rehabilitation doctors to perform respiratory and functional rehabilitation will be considered potential participants. To be eligible for inclusion participants must have been independent in their activities of daily living before the onset of critical illness (verbal statement by their proxy) and have to meet the safety criteria defined by the Portuguese Society of Physical Rehabilitation Medicine. Intervention and comparator Both groups will receive usual medical and nursing care in the ICU, which involves assessment and treatment of the respiratory system and may include positioning, hyperinflation techniques and suctioning. The physical function of the patient is assessed, and active bed exercises and mobility are encouraged as soon as possible and may include sitting out of bed. The intervention group will receive a functional and ...