Clinical trial NCT05756075: The ADAPT-study: Measuring Physical Performance Using Wearable Sensors in Parkinson's Disease and COPD (ADAPT)
Official title: The Accuracy of Digital Assessment of Performance Trial (ADAPT): Walk Test Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
COPD
Keywords: Physical activity
Physical capacity
Walking
Exercise
Wearable sensors
Locomotion
Home-based
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Verily Life Sciences LLC
First posted: 2023-03-06
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any person with Parkinson's Disease or COPD under treatment or newly referred to the participating physiotherapy practices

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean Difference in Distance Walked During 6MWT
timeFrame: Week 0, week 5, week 10 and week 15
Secondary outcomes:
measure: Mean Difference in 6MWD of Study Watch
timeFrame: Week 0 until week 5
measure: Change in Physical Capacity
timeFrame: Week 5 until week 15
measure: Mean Difference in TUG Time
timeFrame: Week 0, Week 5, Week 10, Week 15
measure: Mean Difference in TUG Time of Study Watch
timeFrame: Week 0 until week 5
measure: Change in Gait Speed (10MWT)
timeFrame: Week 0, Week 5, Week 10, Week 15
measure: Change in Cognition (MoCA)
timeFrame: Week 0 and Week 15
measure: Change in Parkinson's Disease Symptoms (MDS-UPDRS)
timeFrame: Week 0, Week 5, Week 10, Week 15
measure: Change in Self-reported Physical Activity Level (LAPAQ)
timeFrame: Week 0, Week 5, Week 10, Week 15
measure: Change in Depression and Anxiety (HADS)
timeFrame: Week 0, Week 5, Week 10, Week 15
measure: Change in Fatigue (FACIT-F13)
timeFrame: Week 0, Week 5, Week 10, Week 15
measure: Change in Sleepiness at Day (ESS)
timeFrame: Week 0, Week 5, Week 10, Week 15
measure: Change in Health Related Quality of Life (PDQ-39)
timeFrame: Week 0, Week 5, Week 10, Week 15
measure: Change in Quality of Life (EQ-5D-5L)
timeFrame: Week 0, Week 5, Week 10, Week 15
measure: Clinical COPD Questionnaire (CCQ)
timeFrame: Week 0, Week 5, Week 10, Week 15
measure: Medical Research Council Dyspnea (mMRC)
timeFrame: Week 0, Week 5, Week 10, Week 15
measure: System Usability Scale (SUS) Questionnaire
timeFrame: Week 15
Other outcomes:
Locations:
city: Aalsmeer
country: Netherlands
facility: Paca
city: Amstelveen
country: Netherlands
facility: Gezondheidscentrum Marne
city: Breda
country: Netherlands
facility: Fysiotherapie Heusdenhout
city: Breda
country: Netherlands
facility: Praktijk Graaf Hendrik III Laan
city: Breda
country: Netherlands
facility: RevaQ
city: Den Haag
country: Netherlands
facility: Praktijk Prins Hendrikstraat
city: Ede
country: Netherlands
facility: Lijf & leven, fit en fysiotherapie
city: Franeker
country: Netherlands
facility: Fysiotherapie De Hertog
city: Goes
country: Netherlands
facility: Zorggroep Ter Weel
city: Heerde
country: Netherlands
facility: Fysio Heerde
city: Heerenveen
country: Netherlands
facility: Tigra
city: Lelystad
country: Netherlands
facility: Centra Plaza Fysiotherapie
city: Lopik
country: Netherlands
facility: Fysiotherapie MTC Lopik
city: Naarden
country: Netherlands
facility: Vivium Fysiotherapie Naarderheem
city: Nieuwegein
country: Netherlands
facility: Manueel Fysiocare
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center
city: Oud Gastel
country: Netherlands
facility: FysioHolland Oud Gastel
city: Roosendaal
country: Netherlands
facility: Van Broekhoven fysiotherapie
city: Rotterdam
country: Netherlands
facility: Praktijk Ed van Bruggen
city: Spijkenisse
country: Netherlands
facility: InMotion
city: Tegelen
country: Netherlands
facility: Fysioteam Tegelen
city: Teteringen
country: Netherlands
facility: Fysiek Vooruit
city: Uden
country: Netherlands
facility: Van der Kieft Fysiotherapie
city: Uithoorn
country: Netherlands
facility: Motion Fysiotherapie & Preventie
city: Vaassen
country: Netherlands
facility: Therapiecentrum Veenstade
city: Valkenswaard
country: Netherlands
facility: Fysio van Hoof, expertisecentrum Reva Vitaal
city: Veenendaal
country: Netherlands
facility: Rembrandt fysiotherapie & revalidatie
city: Veghel
country: Netherlands
facility: Brabantzorg
Study officials:
affiliation: Radboudumc department of Neurology
name: Bastiaan R Bloem, MD, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: de Graaf D, de Vries NM, van de Zande T, Schimmel JJP, Shin S, Kowahl N, Barman P, Kapur R, Marks WJ Jr, van 't Hul A, Bloem BR. 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. JMIR Res Protoc. 2024 May 7;13:e55452. doi: 10.2196/55452.