Untethered six-minute walk test
This multi-site, multi-country study involves a six-minute walk test protocol designed to capture ECG rhythm and heart rate before, during and after the routine, while the patient walks a 90 foot designated path.
This study leveraged Vivalink’s Biometric Data Platform and the wearable ECG monitor to analyze patient heart rate changes throughout the routine.
| Requirements/Challenges | Solution |
| Specific clinical protocol required to manage 6MWT routine | Customized clinical mobile app to match protocol use case |
| Logistical challenges with international sites | Provisioning and direct ship to international sites |
| Aggregating data from multi-sites | Consolidated data for centralized analysis |
| Network disconnections during 6MWT routine | Auto network recovery and data synchronization |
| Ensuring data adherence for RPM devices | Data acquisition reports to monitor adherence |
"Medical wearables are making it possible to explore new, potentially meaningful outcomes in clinical studies without adding much additional burden to patients or their clinicians."
-Robert F. Roscigno, PhD, Vice President, Clinical Development at Gossamer Bio
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