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Parkinson DiseaseADAPTNCT05756075

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

An observational study of Parkinson Disease and COPD, run by Radboud University Medical Center at 28 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Parkinson Disease, COPD
What is being tested?
Aerobic exercise training
How many people
154 participants
Where
28 sitesNetherlands
Study dates
23 Dec 2021to 30 Nov 2023
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Any person with Parkinson's Disease or COPD under treatment or newly referred to the participating physiotherapy practices

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

28 sites in 1 country.

28 sites in 1 country

Netherlands28 sites

  • Paca

    Aalsmeer

  • Gezondheidscentrum Marne

    Amstelveen

  • Fysiotherapie Heusdenhout

    Breda

  • Praktijk Graaf Hendrik III Laan

    Breda

  • RevaQ

    Breda

  • Lijf & leven, fit en fysiotherapie

    Ede

  • Fysiotherapie De Hertog

    Franeker

  • Zorggroep Ter Weel

    Goes

  • Fysio Heerde

    Heerde

  • Tigra

    Heerenveen

  • Centra Plaza Fysiotherapie

    Lelystad

  • Fysiotherapie MTC Lopik

    Lopik

  • Vivium Fysiotherapie Naarderheem

    Naarden

  • Manueel Fysiocare

    Nieuwegein

  • Radboud University Medical Center

    Nijmegen

  • FysioHolland Oud Gastel

    Oud Gastel

  • Van Broekhoven fysiotherapie

    Roosendaal

  • Praktijk Ed van Bruggen

    Rotterdam

  • InMotion

    Spijkenisse

  • Fysioteam Tegelen

    Tegelen

  • Fysiek Vooruit

    Teteringen, 4847 NJ

  • Praktijk Prins Hendrikstraat

    The Hague

  • Van der Kieft Fysiotherapie

    Uden

  • Motion Fysiotherapie & Preventie

    Uithoorn

  • Therapiecentrum Veenstade

    Vaassen

  • Fysio van Hoof, expertisecentrum Reva Vitaal

    Valkenswaard

  • Rembrandt fysiotherapie & revalidatie

    Veenendaal

  • Brabantzorg

    Veghel, 5467 AN

Other trials in Netherlands

About this study

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

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.

Read the 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.

Being tested
Aerobic exercise training
Keywords
Physical activity, Physical capacity, Walking, Exercise, Wearable sensors, Locomotion, Home-based
Medical subject headings
Parkinson Disease, Pulmonary Disease, Chronic Obstructive, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aerobic exercise trainingBehavioural

    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

Study groups in NCT05756075
Study groupRoleWhat they receive
Parkinson's DiseaseNot described
Receives: Behavioral: Aerobic exercise training
COPDNot described
Receives: Behavioral: Aerobic exercise training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Week 0, week 5, week 10 and week 15

Secondary outcomes (16)

  1. Mean Difference in 6MWD of Study Watch

    Difference between 6MWD at home and in-clinic

    Note: not yet reported, data analysis is in progress

    Measured: Week 0 until week 5

  2. Change in Physical Capacity

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

    Measured: Week 5 until week 15

  3. 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

    Measured: Week 0, Week 5, Week 10, Week 15

  4. 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

    Measured: Week 0 until week 5

  5. Change in Gait Speed (10MWT)

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

    Measured: Week 0, Week 5, Week 10, Week 15

  6. 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

    Measured: Week 0 and Week 15

  7. 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.

    note: only the difference in score between week 0 and week 15 is reported

    Measured: Week 0, Week 5, Week 10, Week 15

  8. Change in Self-reported Physical Activity Level (LAPAQ)

    Change from baseline on the Longitudinal Aging Study Amsterdam (LASA) physical Activity Questionnaire (LAPAQ)

    Note: not yet reported, data needs to be analysed

    Measured: Week 0, Week 5, Week 10, Week 15

  9. 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

    Note: only the difference between week 0 and week 15 is reported

    Measured: Week 0, Week 5, Week 10, Week 15

  10. 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.

    Note: not yet reported, data needs to be analysed

    Measured: Week 0, Week 5, Week 10, Week 15

  11. 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.

    Note: not yet reported, data needs to be analysed

    Measured: Week 0, Week 5, Week 10, Week 15

  12. 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

    Note: only the difference between week 0 and week 15 is reported

    Measured: Week 0, Week 5, Week 10, Week 15

  13. 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

    Note: not yet reported, data data needs to be analysed

    Measured: Week 0, Week 5, Week 10, Week 15

  14. 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

    Measured: Week 0, Week 5, Week 10, Week 15

  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

    This test is only completed by the COPD participants as it is a COPD-specific questionnaire.

    Measured: Week 0, Week 5, Week 10, Week 15

  16. System Usability Scale (SUS) Questionnaire

    Usability of the Verily Study Watch. Range 0-13. Higher scores indicate better usability

    Measured: Week 15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2023
  2. Study start23 Dec 2021
  3. Primary completion30 Nov 2023
  4. Study completion30 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
154 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05756075
Sponsor's protocol ID
NL78292.091.21
Acronym
ADAPT
Status last verified
Dec 2022
First submitted
23 Feb 2023
Last updated
12 Mar 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Not decided yet

Publications

  • 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.

    PubMed 38713508

Questions about this trial

What is this clinical trial studying?

An observational study of Parkinson Disease and COPD, run by Radboud University Medical Center at 28 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Difference in Distance Walked During 6MWT (time frame: Week 0, week 5, week 10 and week 15). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05756075, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.

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