The Accuracy of Digital Assessment of Performance Trial; the ADAPT Study

Physical functioning is an important determinant of quality of life and
therefore a relevant issue in people with chronic conditions such as chronic
obstructive pulmonary disease (COPD) and Parkinson*s disease (PD). Physical
capacity and physical activity are distinct and relatively independent aspects
of physical functioning. With the rise of innovative technology, both aspects
have become measurable in the free-living environment of people with chronic
conditions. However, so far, physical capacity and physical activity have
mainly been assessed in in-clinic settings using standardized performance tests
(i.e. Six-Minute Walk Test (6MWT)) and questionnaires (i.e. LASA Physical
Activity Questionnaire), respectively. Here we will examine the validity of a
digital solution to remotely measure physical capacity and physical activity in
two groups of participants: participants with PD and participants with COPD.

We aim to develop and validate algorithms to quantify and track physical
capacity and physical activity to be used as clinical trial endpoints for the
development of pharmacological and non-pharmacological interventions for
participants with COPD and PD. The algorithms will be developed from sensor
data collected on wrist worn devices (Verily Study Watch and, for a subset of
participants, the Fitbit Sense). There will be two contexts for sensor data
collection 1) during the Virtual Walk Test, which is administered via
application on a wrist worn device in the home setting, and 2) during the
free-living context where participants simply wear the device(s) and the
sensor data is passively recorded. In addition to the sensor data, each
participant*s relevant clinical outcomes, patient-reported outcomes, general
demographics and medical history information will also be collected. The
resulting data will be used to develop and/or validate algorithms to estimate
participant*s physical capacity as well as to quantify physical activity of the
participant. By utilizing sensor data from wearable devices and their
associated algorithms, we will be able to obtain frequent assessments of the
participant*s functional physical capacity and granular measurements of
physical activity. These will support an improved ability to measure a
participant's physical functioning at baseline and during treatment, and has
the potential to capture the treatment-related change from baseline. Ultimately
we expect that this effort will contribute to more effective and efficient
development of pharmacological and non-pharmacological interventions for people
with COPD and PD.

We will perform a decentralized, prospective, observational study with a 15
week follow-up.

In Clinic Portion: Participants will come to their assigned local physiotherapy
practice four times (once every five weeks) for in-clinic assessments of
walking capacity, and will be instrumented with up to three sensor wearable
devices (Verily Study Watch, Modus StepWatch 4, and the Fitbit Sense) during
the walk tests. Participants will undergo 10 weeks of physiotherapy treatment
as an intervention. No intervention is provided during the first five weeks of
participation.

Remote Portion: Participants will be instructed to wear the Verily Study Watch
for up to 23 hours per day for the entire study duration (15 weeks), to enable
continuous free-living data collection, and will be asked to perform the
Six-Minute Walk Test (6MWT) and Timed Up and Go test (TUG)) once a week using
the Verily Study Watch. Verily Study Watch will send out notification to
perform 6MWT and TUG and guide participants through the remote assessments. A
subset of participants may also wear the Fitbit Sense concurrently with the
Study Watch and will be asked to wear them for the first 5 weeks between first
and second visits at minimum.

The burden of participating in this study consists of 4 visits to the local
physiotherapy practice for in-clinic assessments of disease status and walking
tests. These visits are scheduled in addition to the usual care physiotherapy
assessments and therefore can be considered an additional burden. Every
in-clinic visit will take approximately 120 minutes in total. In addition,
participants are asked to wear the wearable device(s) continuously for 15 weeks
and perform two walking tests once a week. The walking tests are guided and
prompted by the Study Watch, making it easier to comply with these procedures.
The Verily Study Watch is being used in another study in participants with PD
and the participants showed excellent compliance3, therefore it is expected
that this will be a realistic approach. For those who are willing to wear the
optional device as well as the Verily Study Watch at home (minimum 50 people
with COPD and 30 people with PD), simultaneous wear of the devices on each
wrist, for at least the first five weeks of the study duration, will be an
additional burden. It is expected this would be feasible based on prior studies
where multiple devices were required to be worn for prolonged periods of time
for the people with COPD4 and PD.5-7 In addition, this is not an obligatory
part of the study, and participants can decline wearing multiple devices at the
same time at home.

The main risks related to the safety of performing an unsupervised (submaximal)
aerobic exercise test at home are related to falls and cardiovascular events.
Falls may be more frequent in the PD population, while cardiovascular risk is
higher in COPD because of (potentially undiagnosed) cardiovascular comorbidity.
Risks associated with home measurement will be minimized by excluding
participants that have fallen more than once in the last three months and by
asking the treating physician (i.e. general practitioner, pulmonologist or
neurologist) to assess a person*s ability to participate in this study.
Finally, participants will receive 10 weeks of personalized physiotherapy,
which they would also receive if they would not participate in this study.