A central goal in the management of heart failure (HF) is to improve patient health status and functional capacity, characterized by the ability to perform tasks and activities essential to day-to-day living. Two common tools used to measure health status and functional capacity in HF are the Kansas City Cardiomyopathy Questionnaire-Physical Limitation Score (KCCQ-PLS), a self-administered assessment of health status, and the 6-minute walk test (6MWT), which measures aerobic endurance.
There is growing interest in tracking actual patient activity in order to enhance performance metrics in clinical trials. One approach to doing this involves accelerometer devices that are wearable monitors tracking continuous physical activity data during daily life. Limited evidence is currently available on the use of these devices in HF patients and how they relate to more conventional tools, such as the KCCQ-PLS and 6MWT. In this pre-specified substudy of the VITALITY-HFpEF trial, published in ESC Heart Failure, researchers collected accelerometer data from 69 patients with HF with preserved ejection fraction (HFpEF) to examine the relationship between the changes in accelerometry and the KCCQ-PLS and 6MWT.
The study’s primary objective was to assess patient activity obtained from accelerometry recordings and compare this data to changes in KCCQ-PLS and 6MWT from the study start to week 24. Patients were required to wear activity monitors on their non-dominant wrist for 24 hours a day; any days with wearing time of less than 10 hours were deemed non-compliant and removed from the analysis.
The researchers found that continuous physical activity in patients with HFpEF was significantly lower than the age-adjusted values of a typical adult. Overall, the study results showed no statistically significant correlation between the physical activity data captured by accelerometers and the KCCQ-PLS and 6MWT results. The researchers emphasize the need for further investigation into these devices to better understand their utility for measuring health status and functional capacity in HF patients.
Summarizing the results, Dr. Paul Armstrong states, “We learned a great deal about the practicality and logistics of wearable devices in this study that will be useful in applying wearable technologies in future research.”
This research was conducted on behalf of the VITALITY-HFpEF study group, and was co-authored by CVC Founding Director and VITALITY-HFpEF Study Chair, Dr. Paul Armstrong. Learn more about the VITALITY-HFpEF trial here.
