By David Tuller, DrPH
In a new paper, a team of investigators from the University of South Australia in Adelaide, Australia, describes a “pilot feasibility” trial for an ME/CFS intervention focused on physical activity. The trial fell dramatically short on recruitment efforts—a failure that the investigators appear to explicitly blame on the patient community rather than any possible shortcomings in their approach. The paper, in the journal Translational Exercise Biomedicine, is called “Pacing, conventional physical activity and active video gaming to increase physical activity levels for adults with myalgic encephalomyelitis/chronic fatigue syndrome: a pilot feasibility study.”
A major issue seems to be the basic assumption behind the study–that the question of whether physical activity is rehabilitative for ME/CFS remains unsettled. That assumption is false. The question has been asked and satisfactorily answered: Interventions focused on graded exercise and boosting physical activity do not lead to improvement or recovery. As the UK’s National Institute for Health and Care Excellence (NICE) found in its assessment of the literature for its 2021 guidance on ME/CFS, the quality of evidence in favor of such interventions is either “very low” or merely “low.”
And yet, the Australian investigators write this:
“Physical activity-based (e.g. exercise therapy) interventions are not well understood in this population, with the effectiveness, safety, optimal intervention design, and method of delivery yet to be properly elucidated. A review of eight physical activity-based interventions concluded that whilst definitive conclusions were difficult to draw, it was likely that physical activity had a positive effect on fatigue experienced by adults living with ME/CFS compared to usual care or passive therapies.”
The “review of eight physical activity-based interventions,” cited authoritatively to support the claim that the science is unsettled, is a discredited Cochrane review last revised in 2019. The investigators do not acknowledge Cochrane’s own admission, at the time the 2019 version was published, that the review was not fit for purpose and required an update. In December, Cochrane did an abrupt about-face and cancelled the planned update. The largest study in the Cochrane review was the fraudulent PACE trial, with the overall body of research in this domain marked by a range of serious flaws–as noted by NICE.
Based on their apparent misunderstanding of the state of play, the investigators decided that a gentler form of physical activity might be the answer. They settled on active video-gaming (AVG). What is that? (I didn’t know either.) From the study: “Active video gaming can be broadly summarised as any video game that requires participant trunk and limb movements for game play. Games can be played at home, standing or sitting, and for short periods (e.g., 1–2 min).”
The plan was to divide participants into three arms: pacing alone, pacing combined with conventional physical activity, and pacing combined with AVG. Both the conventional and AVG interventions included incremental increases in activity every two weeks, but these increases were framed as “symptom-contingent.” In other words, participants could decide not to increase their activity, or even reduce it, depending on their response to the intervention. The study included a range ot subjective and objective outcomes.
(As a side issue, the investigators seem to regard pacing as a theory-driven practice rather than a self-help strategy used by patients to avoid relapses. “Pacing draws on elements of self-determination theory by allowing participants to self-regulate their activity within their perceived boundaries, promoting intrinsic motivation and sense of control,” they write. Ok, I guess so. But there’s no need to engage in elaborate theorizing to explain why people with ME choose to pace.)
Unfortunately, recruitment was dismal. Despite an estimated 11,000 people with ME/CFS in South Australia, only a few dozen expressed interest during the 17-month recruitment period. Ultimately, 15 participants enrolled, 12 completed the assigned intervention, and 11 provided follow-up data six months after the intervention. As a result, the investigators concluded that “the feasibility of the intervention was deemed to be low.”
In seeking to explain the recruitment problems, the investigators have successfully found others to blame:
“Recruitment may have been negatively impacted by a small but vocal number of people in the ME/CFS community spreading misinformation about the study via social media and patient support groups. The motive of these individuals was not known although their messaging insisted that (1) physical activity is harmful, and (2) research funds should only be allocated to projects that directly seek to understand the pathological mechanisms and lead to an eventual cure. Although the latter point is entirely understandable, the researchers and stakeholder advisory group members believed the desire to maximise the quality of life for those already suffering from such a debilitating disease is also important, and worthy of research investment.”
Note that the passage does not share the “misinformation” purportedly being spread by these “vocal” patient advocates, although it highlights the critics’ positions on the dangers of physical activity for ME/CFS patients and the need for biomedical research. It is hard to take issue with either of those stances. When those whining about “misinformation” do not back up their statements with examples, it suggests that the issue might not be “misinformation” but differing interpretations of the existing data. The investigators write that “the motive” of these critics was unknown, but their motive appears to have been very clear and eminently reasonable–to prevent harm to patients and to ensure that research funding isn’t wasted.
Participants who completed the AVG intervention reported finding it helpful in some ways; the investigators therefore reported that it was “viewed as acceptable and potentially useful.” However, no one increased their physical activity levels—which was the point of the intervention in the first place. Oh, and did I mention that they had a huge recruitment problem?
We can all agree that it would be great, as the investigators write, “to maximise the quality of life for those already suffering from such a debilitating disease.” But misrepresenting the medical literature in order to pursue research that patients obviously reject does nothing to improve anyone’s quality of life. The critics who challenged the rationale for this research were right.
