Wearable Sensors Are Changing Activity Monitoring for Clinical Trials

What a Validation Study Reveals About Wearable ECGs in Clinical Research

Measuring how much patients move each day is a critical data point in healthcare and research. Activity data help clinicians track recovery, guide treatment plans, and give researchers reliable endpoints for clinical trials. In surgical care, understanding whether a patient can tolerate the physical stress of an operation depends on how accurately their functional capacity is measured.

The problem is that traditional methods have limitations that make it hard to get a complete and reliable picture of patient activity. Self-reported logs can be unreliable, and devices worn on the wrist or hip don’t always capture the full picture of how the body moves. 

Without a validated way to separate sedentary time from active time, the data can be misleading. That’s why a recent validation study set out to determine whether medical-grade, chest-worn ECG patches could reliably distinguish sedentary from ambulatory states in healthy adults.

In this blog, we will cover:

• What a recent study revealed about validating Vivalink’s ECG patch for activity tracking
• Why accurate activity data matters for clinical research, surgical assessment, and patient care
• How validation and ease of use shape the future of wearable adoption in trials and healthcare

Study Spotlight: Validating Wearable Patches for Activity Monitoring

To test the accuracy of the device, a University of Glasgow research team recruited 18 healthy adult volunteers and asked them to perform nine everyday activities. These included sedentary tasks such as sitting, standing, typing, or writing, as well as ambulatory movements like slow, normal, and brisk walking.

Consumer-grade, wrist-worn wearables may suffice for fitness tracking, but they don’t deliver the precise data researchers and clinicians need. Self-reports are often inaccurate, and while gold-standard lab tests like cardiopulmonary exercise testing provide strong data, they are expensive and not widely available. Testing the patch against everyday movements showed it could close the gap between unreliable self-reports and expensive lab tests.

Researchers used Vivalink’s chest-worn ECG patches, which include an embedded accelerometer to capture raw movement data. They analyzed the data using a measure called Mean Amplitude Deviation (MAD), which quantifies the difference between sedentary and active states.

Why Accurate Activity Data Matters for Trials and Patient Care

Using the MAD cut-point identified by the researchers, the patch classified sedentary versus ambulatory activity with 99% accuracy. It also scored just under 1.0 on the AUC scale, a benchmark researchers use to confirm near-perfect performance.

This meant the patch almost never misclassified someone who was sitting still as active, and it consistently detected when participants were moving. The findings highlight potential applications in preoperative risk assessment, where providers need reliable ways to measure patient fitness before surgery. Validated wearables could complement, and in some cases replace, traditional lab-based exercise tests.

Next Steps for Validating Wearables in Real-World Settings

Future validation will be essential. This first study focused on healthy adults in a supervised environment. Testing in more diverse populations, including older adults and patients with chronic conditions, will help confirm that the results hold outside the lab. 

Regardless, the study’s findings open the door to broader applications of wearables in clinical care and research. In healthcare settings, a patch that can accurately capture activity may help with rehabilitation monitoring, chronic disease management, and recovery tracking at home. In trials, it provides researchers and sponsors with more reliable data to strengthen endpoints and reduce uncertainty.

At the same time, patient interest in wearable devices is growing. Vivalink’s recent survey found that nearly 90% of Americans are open to joining fully remote trials, and that the easier the tools are to use, the more likely participants are to stay engaged. Validation studies like this one are vital to demonstrate accuracy while building the trust needed for real-world adoption.