Cardiovascular diseases, according to the World Health Organization, are the leading cause of death globally1. Regular physical activity has been shown to contribute to the decreased risk of developing heart disease. As advancements in medical care improve survival rates of those experiencing chronic heart failure and coronary heart disease2, how physical activity levels impact health outcomes in patients already diagnosed with heart disease becomes increasingly important to understand.
Researchers currently don’t have consensus on the relationship between physical activity levels and health outcomes in people with heart disease, which could differ from recommended physical activity levels for healthy individuals. It’s important to understand this difference to improve secondary prevention programs and prevent repeat cardiac events.
However, current data collection methods to assess physical activity occur either in a laboratory setting over a limited period, and/or are self-reported via questionnaires. These measuresdon’t give clinical researchers the necessary details to create acomprehensive, accurate view of activity levelsin order to make this comparison.
Developing a novel, clinically validated endpoint based on physical activity data collected over time in a real-life setting, such as data collected from a wearable accelerometer,can help address this shortcoming. Using wearable digital health technologies (DHTs) can help researchers gather data on physical activity levels not only in a laboratory setting, but also during daily life activities such as sweeping the floor or watching TV. This type of data can help researchers develop evidence-based, disease-specific physical activity recommendations.
ActiGraph launched the Digital Endpoint Accelerator Research “DEAR” Grant to help address these evidence gaps by partnering with clinical researchers on projects that examine the validity of digital measures as compared to established ground truth measures. One of the researchers receiving this grant is Nicole Freene, PhD, an Associate Professor in Physiotherapy at the University of Canberra.
With the DEAR Grant, Dr. Freene and her research team will identify heart disease-specific accelerometer cut-points that will allow the disease-specific relationship between physical activity and health outcomes to be accurately established. This will guide future physical activity recommendations and interventions, helping more people live longer and healthier lives after a cardiac event.
Dr. Freene is also a practicing physiotherapist, the co-chair of the Asia-Pacific Society of Physical Activity Special Interest Group Physical Activity in Healthcare, and the Cardiorespiratory Lead of the Australian Physiotherapy for Physical Activity group. Her research focuses on increasing physical activity levels and decreasing sedentary behavior in adults, both in healthy and cardiac populations.
The Critical Path Institute’s (C-Path's) Patient-Reported Outcome (PRO) Consortium will collaborate with ActiGraph and the University of Canberraon this project to generate evidence to support regulatory qualification of an accelerometer-based clinical outcome assessment (COA) in patients with chronic heart failure. Development and FDA qualification of an activity monitor-based COA could then be used in clinical trials developing novel therapies for patients with chronic heart failure.
This research project is one of five that have been selected to receive the DEAR Grant, all of which have progressed over the course of 2023. Evidence generated from these studies will accelerate the adoption of wearable data as patient-centered outcomes, which will ultimately improve clinical trial efficiency.