Randomized Feasibility Trial of COVIDEx Rehabilitation Program to Reduce Fatigue After COVID-19 Compared to Standard Care

What this Trial Is About

Long COVID affects about 1.4 million Canadians who have had a SARS-CoV-2 infection, with fatigue being the most common symptom. Researchers are evaluating a new rehabilitation program called COVIDEx to treat fatigue after COVID-19 and compare it to the standard care currently used. This randomized feasibility trial uses a modified Zelen design to study rehabilitation under real-world conditions, focusing on effectiveness and patient-reported outcomes for individuals living with Long COVID. Participants are randomly assigned to either the COVIDEx group or standard care. The COVIDEx group takes part in an 8-week program with two 50-minute virtual group sessions weekly, including warm-up, cardio, balance training, breathing exercises, cognitive training, strengthening, and stretching, all paced to prevent post-exertional malaise PEM. The standard care group receives no intervention during this period but is offered COVIDEx after study completion. The study includes blood oxygen and heart rate monitoring using Apple Watches, and participants use an app to report symptoms at random times up to 24 weeks. Participants will be assessed at baseline and at 4, 8, 12, and 24 weeks for various outcomes such as fatigue, physical exertion, brain function, and quality of life. The study collects both quantitative and qualitative data, including one-on-one interviews with COVIDEx participants to explore program acceptability and adherence. The total follow-up period is 24 weeks, and safety monitoring includes tracking symptom flare-ups and metabolic responses during exercise sessions.

Pursuing Reduction in Fatigue After COVID-19 Via Exercise and Rehabilitation (PREFACER): A Randomized Feasibility Trial