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de Graaf D, de Vries NM, van de Zande T, Rigters-Schimmel J, Shin S, Kowahl N, Barman P, Kapur R, Marks WJ Jr, van 't Hul A, Bloem B
Measuring Physical Functioning Using Wearable Sensors in Parkinson Disease and Chronic Obstructive Pulmonary Disease (the Accuracy of Digital Assessment of Performance Trial Study): Protocol for a Prospective Observational Study
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
The ADAPT-study protocol: measuring physical functioning using wearable sensors in Parkinson’s Disease and COPD
Debbie de Graaf;
Nienke M de Vries;
Tessa van de Zande;
Janneke Rigters-Schimmel;
Sooyoon Shin;
Nathan Kowahl;
Poulami Barman;
Ritu Kapur;
William J. Marks Jr;
Alex van 't Hul;
Bastiaan Bloem
ABSTRACT
Background:
Physical capacity and physical activity are important aspects of physical functioning and quality of life in people with a chronic disease such as Parkinson’s Disease (PD) or Chronic Obstructive Pulmonary Disease (COPD). Both physical capacity and physical activity are currently measured in-clinic using standardized questionnaires and tests, such as the 6-minute walk test (6MWT) and Timed Up and Go test (TUG). However, relying only on in-clinic tests is suboptimal since they offer limited information on how a person functions in daily life and how functioning fluctuates throughout the day. Wearable sensor technology may offer a solution that enables us to better understand true physical functioning in daily life.
Objective:
We aim to study whether a device assisted 6MWT and TUG, such that test can be performed independently at home using a smartwatch, is a valid and reliable way to measure the performance compared to a supervised, in-clinic test.
Methods:
This is a decentralized, prospective, observational study including 100 people with PD and 100 with COPD. The inclusion criteria are broad: ≥ 18 years, able to walk independently and no co-occurrence of PD and COPD. Participants are followed for 15 weeks with four in-clinic visits, once every 5 weeks. Outcomes include several walking tests, cognitive tests and disease specific questionnaires accompanied with data collection using wearable devices (the Verily Study Watch and Modus StepWatch). Additionally, during the last 10 weeks of the study, participants will follow an aerobic exercise training program aiming to increase physical capacity, and creating the opportunity to study the responsiveness of the remote 6MWT.
Results:
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Conclusions:
The results of this study give information on the measurement properties of the device assisted 6MWT and TUG in-clinic and at home. When reliable and valid, this can contribute to a better understanding of a person’s physical capacity in real life, which makes it possible to personalize treatment options. Clinical Trial: NCT05756075
Citation
Please cite as:
de Graaf D, de Vries NM, van de Zande T, Rigters-Schimmel J, Shin S, Kowahl N, Barman P, Kapur R, Marks WJ Jr, van 't Hul A, Bloem B
Measuring Physical Functioning Using Wearable Sensors in Parkinson Disease and Chronic Obstructive Pulmonary Disease (the Accuracy of Digital Assessment of Performance Trial Study): Protocol for a Prospective Observational Study