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REGAIN trial for Long Covid

In December we became aware of a trial from the University of Warwick investigating whether online exercise programmes could help people recovering from Covid-19. The trial is called “REGAIN” and aims to compare a single online session of exercise advice and support with an 8 week online exercise and support programme.


Participants in the study must have been treated in hospital for Covid 19 and be suffering health problems more than three months later.


From looking at the study information we had several concerns, summarised as:


- There was no mention of the identification of post viral fatigue syndrome symptoms (in particular post exertional malaise) in the exclusion criteria

- The protocol says appropriately trained members of the team will conduct the eligibility screening, however as neither physiotherapists or exercise physiologists have expertise in supporting people with PVFS, we would anticipate that additional training in identifying PVFS would be required.


- As we know many people who develop post viral fatigue and Long Covid are in a cohort who has not been admitted to hospital, we were concerned that any findings may be overly generalised without taking this into account.


From looking at the responses on social media we knew we were not alone in our concerns, but were very pleased to receive an invitation from the REGAIN trial team to discuss the trial protocol in more detail. Along with representatives from the “Long Covid Physio” team, we met with the trial team just before Christmas and were able to outline our concerns.


Although we were pleased to have been able to meet the team, we have as yet had no further outcome from the meeting or acknowledgement that the protocol may need to be altered to include staff training and screening for post viral fatigue symptoms.


We note that the website currently says: We do not anticipate any serious risk to you. There is always a very small chance that exercise can make you feel unwell. You will be advised and monitored by specialist staff. Exercise may cause tiredness, breathlessness and sore muscles, but this should get a bit easier each time you exercise.”


It is unfortunate that this continues to leave out any mention of the potential for post exertional malaise and the risk of continued exercise in this instance.


As physiotherapists, we are knowledgeable and enthusiastic about promoting physical activity and recognise and support the benefits of exercise and psychological support particularly after admission to ITU. We therefore wholly support research to help develop understanding of the management of long covid in this cohort.


However, with the National Institute of Health Research describing post viral fatigue syndrome as one of four types of long covid, we remain concerned that many studies into long covid are failing to acknowledge the importance of screening for post exertional malaise.


We have now written to the National Institute for Health Research to outline the same concerns regarding this trial. You can read our notes in depth here:

review of REGAIN study
.pdf
Download PDF • 78KB

If we receive any updates we will endeavour to share them.


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