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

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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease; COPD
• Intervention / Treatment: Behavioral: Aerobic exercise training

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.

• Study Type: Observational
• Enrollment (Actual): 154

Contacts and Locations

Study Locations

• Netherlands
  • Aalsmeer, Netherlands
    • Paca
  • Amstelveen, Netherlands
    • Gezondheidscentrum Marne
  • Breda, Netherlands
    • Fysiotherapie Heusdenhout
  • Breda, Netherlands
    • Praktijk Graaf Hendrik III Laan
  • Breda, Netherlands
    • RevaQ
  • Den Haag, Netherlands
    • Praktijk Prins Hendrikstraat
  • Ede, Netherlands
    • Lijf & leven, fit en fysiotherapie
  • Franeker, Netherlands
    • Fysiotherapie De Hertog
  • Goes, Netherlands
    • Zorggroep Ter Weel
  • Heerde, Netherlands
    • Fysio Heerde
  • Heerenveen, Netherlands
    • Tigra
  • Lelystad, Netherlands
    • Centra Plaza Fysiotherapie
  • Lopik, Netherlands
    • Fysiotherapie MTC Lopik
  • Naarden, Netherlands
    • Vivium Fysiotherapie Naarderheem
  • Nieuwegein, Netherlands
    • Manueel Fysiocare
  • Nijmegen, Netherlands
    • Radboud University Medical Center
  • Oud Gastel, Netherlands
    • FysioHolland Oud Gastel
  • Roosendaal, Netherlands
    • Van Broekhoven fysiotherapie
  • Rotterdam, Netherlands
    • Praktijk Ed van Bruggen
  • Spijkenisse, Netherlands
    • InMotion
  • Tegelen, Netherlands
    • Fysioteam Tegelen
  • Teteringen, Netherlands, 4847 NJ
    • Fysiek Vooruit
  • Uden, Netherlands
    • Van der Kieft Fysiotherapie
  • Uithoorn, Netherlands
    • Motion Fysiotherapie & Preventie
  • Vaassen, Netherlands
    • Therapiecentrum Veenstade
  • Valkenswaard, Netherlands
    • Fysio van Hoof, expertisecentrum Reva Vitaal
  • Veenendaal, Netherlands
    • Rembrandt fysiotherapie & revalidatie
  • Veghel, Netherlands, 5467 AN
    • Brabantzorg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Parkinson's Disease	Behavioral: Aerobic exercise training; 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
COPD	Behavioral: Aerobic exercise training; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Collaborators: Verily Life Sciences LLC
• Investigators: Principal Investigator: Bastiaan R Bloem, MD, PhD., Radboudumc department of Neurology

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2021
• Primary Completion (Actual): November 30, 2023
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: February 23, 2023
• First Submitted That Met QC Criteria: February 23, 2023
• First Posted (Actual): March 6, 2023

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Exercise; Physical activity; Walking; Locomotion; Wearable sensors; Physical capacity; Home-based
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: NL78292.091.21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Not decided yet
• IPD Sharing Time Frame: Not decided yet
• IPD Sharing Access Criteria: Not decided yet
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No