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

Completed

Conditions: Parkinson Disease
COPD

Interventions: Behavioral: Aerobic exercise training

Registration Number: NCT05756075

Lead Sponsor: Radboud University Medical Center

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 154

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 & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Parkinson's Disease	Aerobic exercise training	-
COPD	Aerobic exercise training	-

Primary Outcome Measures

Name	Time	Method
Mean Difference in Distance Walked During 6MWT	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 Outcome Measures

Name	Time	Method
Mean Difference in 6MWD of Study Watch	Week 0 until week 5	Difference between 6MWD at home and in-clinic Note: not yet reported, data analysis is in progress
Change in Physical Capacity	Week 5 until week 15	Change in 6MWD from week 5 until week 15 after aerobic exercise capacity training
Mean Difference in TUG Time	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
Mean Difference in TUG Time of Study Watch	Week 0 until week 5	Difference between TUG time at home and in-clinic Note: not yet reported, data needs to be analysed s
Change in Gait Speed (10MWT)	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
Change in Cognition (MoCA)	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
Change in Parkinson's Disease Symptoms (MDS-UPDRS)	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
Change in Self-reported Physical Activity Level (LAPAQ)	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
Change in Depression and Anxiety (HADS)	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
Change in Fatigue (FACIT-F13)	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
Change in Sleepiness at Day (ESS)	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
Change in Health Related Quality of Life (PDQ-39)	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
Change in Quality of Life (EQ-5D-5L)	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
Clinical COPD Questionnaire (CCQ)	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
Medical Research Council Dyspnea (mMRC)	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.
System Usability Scale (SUS) Questionnaire	Week 15	Usability of the Verily Study Watch. Range 0-13. Higher scores indicate better usability

Trial Locations

Locations (28): Praktijk Prins Hendrikstraat
🇳🇱
Den Haag, Netherlands
Zorggroep Ter Weel
🇳🇱
Goes, Netherlands
Fysioteam Tegelen
🇳🇱
Tegelen, Netherlands
Fysiek Vooruit
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Teteringen, Netherlands
RevaQ
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Breda, Netherlands
Tigra
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Heerenveen, Netherlands
Van der Kieft Fysiotherapie
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Uden, Netherlands
Praktijk Graaf Hendrik III Laan
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Breda, Netherlands
FysioHolland Oud Gastel
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Oud Gastel, Netherlands
Van Broekhoven fysiotherapie
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Roosendaal, Netherlands
Therapiecentrum Veenstade
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Vaassen, Netherlands
Brabantzorg
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Veghel, Netherlands
Paca
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Aalsmeer, Netherlands
Fysiotherapie De Hertog
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Franeker, Netherlands
Fysiotherapie MTC Lopik
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Lopik, Netherlands
Gezondheidscentrum Marne
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Amstelveen, Netherlands
Fysiotherapie Heusdenhout
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Breda, Netherlands
Fysio Heerde
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Heerde, Netherlands
Manueel Fysiocare
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Nieuwegein, Netherlands
Motion Fysiotherapie & Preventie
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Uithoorn, Netherlands
Fysio van Hoof, expertisecentrum Reva Vitaal
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Valkenswaard, Netherlands
Rembrandt fysiotherapie & revalidatie
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Veenendaal, Netherlands
Lijf & leven, fit en fysiotherapie
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Ede, Netherlands
Centra Plaza Fysiotherapie
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Lelystad, Netherlands
Vivium Fysiotherapie Naarderheem
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Naarden, Netherlands
Radboud University Medical Center
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Nijmegen, Netherlands
Praktijk Ed van Bruggen
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Rotterdam, Netherlands
InMotion
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Spijkenisse, Netherlands