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Completed

NCT Number: NCT05756075

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aerobic Exercise Training

Behavioral

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

Primary outcomes

  1. Mean Difference in Distance Walked During 6MWT

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

    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

Secondary outcomes

  1. Mean Difference in 6MWD of Study Watch

    Time frame: Week 0 until week 5

    Difference between 6MWD at home and in-clinic

    Note: not yet reported, data analysis is in progress

  2. Change in Physical Capacity

    Time frame: Week 5 until week 15

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

  3. Mean Difference in TUG Time

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

    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

  4. Mean Difference in TUG Time of Study Watch

    Time frame: Week 0 until week 5

    Difference between TUG time at home and in-clinic

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

  5. Change in Gait Speed (10MWT)

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

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

  6. Change in Cognition (MoCA)

    Time frame: Week 0 and Week 15

    Change from baseline on the Montreal Cognitive Assessment (MoCA) score at 15 weeks. Range 0-30. Higher scores indicate better cognition

  7. Change in Parkinson's Disease Symptoms (MDS-UPDRS)

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

    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

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

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

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

    Note: not yet reported, data needs to be analysed

  9. Change in Depression and Anxiety (HADS)

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

    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

  10. Change in Fatigue (FACIT-F13)

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

    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

  11. Change in Sleepiness at Day (ESS)

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

    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

  12. Change in Health Related Quality of Life (PDQ-39)

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

    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

  13. Change in Quality of Life (EQ-5D-5L)

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

    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

  14. Clinical COPD Questionnaire (CCQ)

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

    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

  15. Medical Research Council Dyspnea (mMRC)

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

    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.

  16. System Usability Scale (SUS) Questionnaire

    Time frame: Week 15

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

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Collaborators

  • Verily Life Sciences LLC

Registry information

Official study title

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

Acronym: ADAPT

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Mar 6, 2023
Registry last updated
Mar 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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