Earlier in 2021, concerns were raised by people with ME about the REGAIN clinical trial  and whether there was a risk to people suffering from post-viral symptoms, particularly post-exertional malaise. The REGAIN study aims to find out which of two treatments is better for helping people recover after being in hospital with Covid 19 – an online rehabilitation and recovery support group OR a single online session of exercise advice and support.

In response to those concerns, two people from #MEAction UK and #MEAction global’s Director of Scientific and Medical Outreach, Jaime Seltzer, had a very useful online meeting with the main clinical leads on the REGAIN team.  #MEAction explained our concerns that the publicity about the trial had made no mention of any need for caution in taking part in an exercise programme. We detailed why exercise is inappropriate and potentially dangerous for people with post-exertional malaise, and the need for such people to be screened out of any exercise programme that might encourage people to do more than they could safely within their “energy envelope”.  We discussed how post-exertional malaise can be identified.  

The team explained that the trial had been developed with oversight from a patient group and anyone taking part in the trial had an initial one hour one-to-one session with a practitioner.  They explained that once someone had been accepted onto the trial, the team could not exclude them as that would be altering the protocol which the trial was following. (They made the point that that is one of the criticisms of the PACE trial.) However, they agreed it was important to identify anyone with post-exertional malaise, explain fully to them the risks and that participants are able to withdraw from any part of the trial without any impact on health care options. A participant could, for instance, choose to continue in the support group sessions only. The team welcomed further information from us on identifying post-exertional malaise and Jaime Seltzer sent her advice on that.  

At a follow-up meeting, the practitioners demonstrated that they have adapted some procedures based on #MEAction’s input and advice.  Practitioner training materials and the trial manual have been amended to include a section on post-exertional malaise.  Screening criteria for post-exertional malaise had been added to the pre/post activity monitoring and at various other points. We found the team willing to listen to the advice and experience we were giving, and we are very pleased that we were able to influence the methodology of the trial.  

If anyone has experience of the trial and wishes to share this with us, please do contact us at [email protected]