Validity and reliability of an app-based medical device to empower individuals in evaluating their physical capacities

Background: Cardiorespiratory fitness and muscle strength are valid markers of health and strong predictors of mortality and morbidity. The tests used to measure these variables require in-person visits with specialized equipment and trained personnel–leading to organizational constraints both for patients and hospitals, and making them difficult to implement at a large scale. In this context, technologies embedded in smartphones offer new opportunities to develop remote tests. Objectives: This study aimed to test the validity and reliability of MediEval, a newly developed app-based medical device that allows individuals to perform the 6-minute walk test (6MWT) and the 30-second sit-to-stand (30s-STS) test on their own using GPS signal and camera detection with a skeleton extraction algorithm. Methods: A total of 53 healthy adults performed the two tests in three different sessions to determine the intra- and inter-day reproducibility. Test validity was assessed by comparing the results obtained from the app to gold standard measures. Pearson correlations and concordance correlation coefficients, the relative measurement error, intraclass correlation coefficients, the standard error of measure and the minimal detectable change were computed for each test.s Results: The results revealed high to excellent validity of the app in comparison to gold standards (ρ = 0.84 for the 6MWT and ρ = 0.99 for the 30s-STS test) with low relative measurement error. The mean differences between the app and the gold standard measures were 8.96m for the 6MWT and 0.28 repetition for the 30s-STS test. Both tests had good test-retest reliability (ICCs = 0.77). The minimal detectable changes were respectively 97.56 meters for the 6MWT and 7.37 repetitions for the 30s-STS test. Conclusion: The MediEval medical device proposes valid and reproducible measures of the 6MWT and the 30s-STS test. This device holds promise for monitoring the physical activity of large epidemiologic cohorts while refining patient experience and improving the scalability of the healthcare system. Considering minimal detectable change values, it may be important to ask participants to perform several tests and average them to improve accuracy. Future studies in clinical context are needed to evaluate the responsiveness and the smallest detectable changes of the device for specific populations with chronic diseases.