Therapeutic respiratory and functional rehabilitation protocol for intensive care unit patients affected by COVID-19: a structured summary of a study protocol for a randomised controlled trial

AbstractObjectivesThe 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 designThis is a randomized, controlled, double-blind, double-arm clinical trial of treatment, with an allocation ratio 1:1 and framework of superiority.ParticipantsThe 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 ...
Source: Trials - Category: Research Source Type: clinical trials