The ADAPT-study: Measuring Physical Performance Using Wearable Sensors in Parkinson's Disease and COPD (ADAPT)

Radboud University Medical Center154 enrolled

Overview

The aim of this study is to investigate whether a smartwatch can measure the physical capacity of patients with Parkinson's Disease and COPD in the physiotherapy practice and at home.

Physical capacity and physical activity are important factors for healthy aging and are found to be predictors of disability, morbidity and mortality in healthy older adults and in people with chronic diseases like Parkinson's Disease and COPD. Physical capacity and activity have mainly been assessed in in-clinic settings using standardized tests and subjective questionnaires. Relying only on in-clinic tests is suboptimal because the tests give limited information on how a patient functions in daily life and cannot capture fluctuations and subtle decrements in disease symptoms. With the rise of innovative technology like wearable sensors, both aspects have become measurable in the patients daily life. Here, the investigators will study a wrist worn device (The Verily Study Watch) that has the ability to measure physical activity and physical capacity passively and remotely. The primary focus is on its opportunity to measure physical capacity using the 6MWT, referred to as the virtual 6MWT. The watch tags the start and end of the 6 minutes when performing this test. Also, participants can perform the test independently at home. The Study Watch has the options for remote testing of the Timed Up and Go test (TUG) as well. The aim of this study is to investigate whether the virtual 6MWT validly predicts 6MWT outcomes as measured during a supervised, in-clinic test. A valid virtual 6MWT will be extremely valuable for assessing physical capacity in the home situation longitudinally. This will contribute to a more effective and personalized treatment for people with chronic diseases. The study has a duration of 15 weeks, with 4 in-clinic visits at the physiotherapy practice every five weeks. During those visits, several physical capacity tests will be performed alongside tests and questionnaires related to demographics and disease status. Participants will perform the 6MWT and TUG at home on a weekly basis on a pre-set day and time using the Verily Study Watch. Between week 5 and 15 of the study, participants will follow a standardized aerobic exercise training program according to the most recent regulations.

Study Type

OBSERVATIONAL

Enrollment

154

Conditions

Parkinson Disease COPD

Interventions

Aerobic exercise trainingBEHAVIORAL

Participants will follow a personalized aerobic exercise training program twice a week at the physiotherapist. The intensity of the program is based on the results of the 6MWT according to the most recent guidelines for physiotherapy for PD and COPD

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participant is able to read and understand Dutch * Participant is willing, competent, and able to comply with all aspects of the protocol, including follow-up schedule * Participant is willing and able to complete patient-reported questionnaires via internet * Participant can walk * (PD-specific) Hoehn and Yahr 1-2 * (COPD-specific) Participant has COPD irrespective of airway obstruction severity and has a limited exercise capacity as judged by the physiotherapist Exclusion Criteria: * Participant is allergic to nickel * Participant cannot make an arm swing or is in a situation that prevents arm swing completely * Co-occurence of COPD and PD * Participant has cognitive impairment that would prevent understanding and performing tasks in the study * Participant is pregnant or plans to become pregnant during the course of the study * Participant is participating in another investigational drug or device study * Participant has a high fall risk or cardiovascular risk profile * Participant has any disease or condition that prevents understanding or communication of informed consent, study demands, and testing protocols

Locations (28)

Paca

Aalsmeer, Netherlands

Outcomes

Primary Outcomes

Mean Difference in Distance Walked During 6MWT

Mean difference in distance walked during the 6MWT (6MWD) derived from the Verily Study Watch and clinician measured distance. Note: reported outcome is the mean difference in 6MWD between week 0 and week 15 and is determined as the difference between the two clincian measured distances. The walking distance derived from the Verily Study Watch needs to be determined, this is work in progress

Time frame: Week 0, week 5, week 10 and week 15

Secondary Outcomes

Mean Difference in 6MWD of Study Watch

Difference between 6MWD at home and in-clinic Note: not yet reported, data analysis is in progress

Time frame: Week 0 until week 5

Change in Physical Capacity

Change in 6MWD from week 5 until week 15 after aerobic exercise capacity training

Time frame: Week 5 until week 15

Mean Difference in TUG Time

Mean difference in time to complete the Timed Up and Go test turing the TUG derived from the verily study watch and clinician measured outcome Note: not yet reported, data needs to be analysed

Time frame: Week 0, Week 5, Week 10, Week 15

Mean Difference in TUG Time of Study Watch

Difference between TUG time at home and in-clinic Note: not yet reported, data needs to be analysed s

Time frame: Week 0 until week 5

Change in Gait Speed (10MWT)

The difference in time to complete the 10MWT with and without cognitive task while walking and over time

Time frame: Week 0, Week 5, Week 10, Week 15

Data from ClinicalTrials.gov

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