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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Accuracy of Digital Assessment of Performance Trial (ADAPT): Walk Test Study

Conditions
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COPD, Parkinson Disease

Intervention / Treatment
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* Behavioral: Aerobic exercise training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Parkinson's Disease<br> | Behavioral: Aerobic exercise training<br>* 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<br>|
| COPD<br> | Behavioral: Aerobic exercise training<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean difference in distance walked during 6MWT | Mean difference in distance walked during the 6MWT (6MWD) derived from the Verily Study Watch and Modus StepWatch and clinician measured distance | Week 0, week 5, week 10 and week 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean difference in 6MWD of Study Watch | Difference between 6MWD at home and in-clinic | Week 0 until week 5 | 
| Change in physical capacity | Change in 6MWD from week 5 until week 15 after aerobic exercise capacity training | 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 | 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 | 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 | Week 0, Week 5, Week 10, Week 15 | 
| Change in cognition (MoCA) | Change from baseline on the Montreal Cognitive Assessment (MoCA) score at 15 weeks. Range 0-30. Higher scores indicate better cognition | Week 0 and Week 15 | 
| Change in Parkinson's Disease symptoms (MDS-UPDRS) | Change from baseline in the Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) at week 5, week 10 and week 15. Range 0-199. Higher scores indicate worse function. | Week 0, Week 5, Week 10, Week 15 | 
| Change in self-reported physical activity level (LAPAQ) | Change from baseline on the Longitudinal Aging Study Amsterdam (LASA) physical Activity Questionnaire (LAPAQ) | Week 0, Week 5, Week 10, Week 15 | 
| Change in depression and anxiety (HADS) | Change from baseline on the Hospital Anxiety and Depression Scale (HADS) at week 5, week 10 and week 15. Range 0-42. Higher scores indicate worse function | Week 0, Week 5, Week 10, Week 15 | 
| Change in fatigue (FACIT-F13) | Change from baseline on the Functional Assessment of Chronic Illness Therapy (FACIT-F) 13-item at week 5, week 10 and week 15. Range 0-52. Higher scores indicate better function. | Week 0, Week 5, Week 10, Week 15 | 
| Change in sleepiness at day (ESS) | Change from baseline on the Epworth Sleepiness Scale at week 5, week 10 and week 15. Range 0-24. Higher scores indicate worse function. | Week 0, Week 5, Week 10, Week 15 | 
| Change in health related quality of life (PDQ-39) | Change from baseline on the Health related quality of life (PDQ-39) questionnaire at week 5, week 10 and week 15. Range 0-100. HIgher scores indicate better function | Week 0, Week 5, Week 10, Week 15 | 
| Change in quality of life (EQ-5D-5L) | Change from baseline in the EQ-5D-5L scores at week 5, week 10 and week 15. Range 0-25. Higher scores indicate worse function | Week 0, Week 5, Week 10, Week 15 | 
| Clinical COPD questionnaire (CCQ) | Assessment of and change in health related quality of life from baseline and at week 5, week 10 and week 15. Range 0-60. Higher scores indicate worse function | Week 0, Week 5, Week 10, Week 15 | 
| Medical Research Council Dyspnea (mMRC) | Assessment of dyspnea severity at baseline, week 5, week 10 and week 15. Range 0-4. Higher scores indicate worse function | Week 0, Week 5, Week 10, Week 15 | 
| System Usability Scale (SUS) questionnaire | Usability of the Verily Study Watch. Range 0-13. Higher scores indicate better usability | Week 15 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical activity, Physical capacity, Walking, Exercise, Wearable sensors, Locomotion, Home-based