Yes, so the PEARL study is the proteomic response to exercise in restless leg syndrome. It’s a pilot study, so we’re looking to examine the effect of both acute and chronic exercise in people with restless leg syndrome and how it affects their symptoms. So far, we’ve enrolled 14 individuals who’ve completed the baseline testing for the acute aspect, which is what I’m presenting on here at the conference...
Yes, so the PEARL study is the proteomic response to exercise in restless leg syndrome. It’s a pilot study, so we’re looking to examine the effect of both acute and chronic exercise in people with restless leg syndrome and how it affects their symptoms. So far, we’ve enrolled 14 individuals who’ve completed the baseline testing for the acute aspect, which is what I’m presenting on here at the conference. And what that involves is the individuals are randomized into either exercise or control condition, but everybody goes through the baseline testing. And that includes a week of wearing accelerometers, measuring restless leg syndrome severity, among other things in a sleep diary. And then we have them come in in the middle of that week where they’re measuring each day for a week. In the middle of that week, they come in and do maximal exercise testing on a treadmill and then maximal strength testing on a Humac Norm for their lower extremities. Yes, so it’s all very preliminary. What we’re seeing so far, I guess I should start with what we were expecting to see. For people with RLS, a lot of times we hear anecdotal reports of exercise making their symptoms worse, particularly anything that’s more than what their body’s used to, so higher intensity, a lot of lower leg involvement, any abrupt change in their activity levels. So what we would anticipate with a single bout or acute bout of high-intensity exercise is that their symptoms would get worse, right? At least the first night after exercise. And what we actually saw was that their symptoms stayed relatively stable on average. So if you look at the week of symptoms, it was unchanged based statistically so far in the 14 individuals we’ve had. And then when we look at just the night post-exercise compared to kind of their pre-night baseline, their symptoms significantly improved on average, which is not exactly what we expected to see. But again, we’re only in 14 individuals so far. And then when we look at the individual response, the response heterogeneity of those individuals, we did have three people report that their symptoms worsened that first night. But it was all very minimal. I think it was a three-point change, less than a three-point change for those individuals. So whether that’s clinically significant is to be determined.
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