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Keywords: Actigraphy, 6MWT, functional capacity, digital health technology, wearable devices
As digital health technology for wearable devices advances, so does the interest in using these devices for clinical studies. The detail and sheer volume of data that is produced, while opening opportunities to a better understanding of health conditions and potentially more accurate clinical endpoints, also produces challenges in assessing the quality and precision of the data.
The six-minute walk test (6MWT) is a well-known endpoint used for measuring functional capacity in certain types of cardiovascular studies. There are, however, a number of documented drawbacks to this measure which has led some to examine the potential use of activity monitors for endpoints that do not have these drawbacks. There are numerous challenges in obtaining and analyzing data from these monitors in an accurate manner that neither oversimplifies the patients’ experience, nor overwhelms the investigators with data. It is also imperative to adequately train patients on the use of DHTs and make technical assistance available to users to assist with problems that emerge when using DHTs. Overcoming challenges associated with actigraphy devices could potentially lead to more informative studies that could transform how studies using traditional endpoints like the 6MWT are designed.