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https://www.virology.ws/2022/04/23/...gmgQ93DVbgqAHG4aZdUaisp6U7VUOLGMO8aIj7_Cxj_nk
Trial By Error: Now a Scottish Long Covid Study Fails to Mention the Risk of Post-Exertional Malaise
23 April 2022 Leave a Comment
By David Tuller, DrPH
*April is crowdfunding month at UC Berkeley. If you like my work, consider making a tax-deductible donation to Berkeley’s School of Public Health to support the Trial By Error project: https://crowdfund.berkeley.edu/project/31347
Trial By Error: Now a Scottish Long Covid Study Fails to Mention the Risk of Post-Exertional Malaise
23 April 2022 Leave a Comment
By David Tuller, DrPH
*April is crowdfunding month at UC Berkeley. If you like my work, consider making a tax-deductible donation to Berkeley’s School of Public Health to support the Trial By Error project: https://crowdfund.berkeley.edu/project/31347
And here’s another major trial designed by investigators who think that an exercise program might be the optimal strategy for treating the complex grab-bag of conditions known as long Covid. As with other long Covid research, these investigators seem either unaware of or unconcerned about the core ME/CFS symptom known as post-exertional malaise (PEM)–also called post-exertional symptom exacerbation (PESE) or, in the ME-ICC case definition, post-exertional neuroimmune exhaustion (PENE).
The study in question is called “Prevention and Early Treatment of the Long-term Physical Effects of Coronarvirus-19 (COVID-19): a Randomised Clinical Trial of Resistance Exercise.” Conducted by the University of Glasgow, in conjunction with NHS Greater Glasgow and Clyde, it is funded by Scotland’s Chief Scientist Office, which two decades ago also kicked in some of the funding for the now-discredited PACE trial.
The projected sample size is 220. Recruitment began last May and is expected to continue into next year. A twitter thread critiquing the study caught my attention.
The investigators are recruiting patients still experiencing symptoms four weeks or more after the onset of infection, including both those who were hospitalized for Covid-19 and those who weren’t. Another group of hospitalized patients is being tracked from shortly after infection to determine if the exercise intervention can prevent prolonged symptoms. All participants also receive standard care. Those in the comparison arm get only standard care—a typical feature of many such behavioral intervention studies.
Unlike key members of the GET/CBT ideological brigades, the Glasgow investigators seem to recognize that measures of function, and not just self-reported measures like fatigue and physical function, are critical. While the multiple assessments include a range of subjective questionnaires, the primary outcome is something called the Shuttle Walk Test. Here is how it is described in a version of the patient information sheet from March, 2021: