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| Name | Class |
|---|---|
| Verily Life Sciences LLC | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Parkinson's Disease |
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| COPD |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 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 | Week 0, week 5, week 10 and week 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Difference in 6MWD of Study Watch | Difference between 6MWD at home and in-clinic Note: not yet reported, data analysis is in progress | Week 0 until week 5 |
| Change in Physical Capacity | Change in 6MWD from week 5 until week 15 after aerobic exercise capacity training |
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Inclusion Criteria:
Exclusion Criteria:
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Any person with Parkinson's Disease or COPD under treatment or newly referred to the participating physiotherapy practices
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| Name | Affiliation | Role |
|---|---|---|
| Bastiaan R Bloem, MD, PhD. | Radboudumc department of Neurology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Paca | Aalsmeer | Netherlands | ||||
| Gezondheidscentrum Marne |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38713508 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Parkinson's Disease | 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 |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 15, 2024 |
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| Week 5 until week 15 |
| 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 | 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 Note: not yet reported, data needs to be analysed s | 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 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. note: only the difference in score between week 0 and week 15 is reported | 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) Note: not yet reported, data needs to be analysed | 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 Note: only the difference between week 0 and week 15 is reported | 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. Note: not yet reported, data needs to be analysed | 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. Note: not yet reported, data needs to be analysed | 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 Note: only the difference between week 0 and week 15 is reported | 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 Note: not yet reported, data data needs to be analysed | 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 This test is only completed by the COPD participants as it is a COPD-specific questionnaire. | 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 |
| Amstelveen |
| Netherlands |
| Fysiotherapie Heusdenhout | Breda | Netherlands |
| Praktijk Graaf Hendrik III Laan | Breda | Netherlands |
| RevaQ | Breda | Netherlands |
| Lijf & leven, fit en fysiotherapie | Ede | Netherlands |
| Fysiotherapie De Hertog | Franeker | Netherlands |
| Zorggroep Ter Weel | Goes | Netherlands |
| Fysio Heerde | Heerde | Netherlands |
| Tigra | Heerenveen | Netherlands |
| Centra Plaza Fysiotherapie | Lelystad | Netherlands |
| Fysiotherapie MTC Lopik | Lopik | Netherlands |
| Vivium Fysiotherapie Naarderheem | Naarden | Netherlands |
| Manueel Fysiocare | Nieuwegein | Netherlands |
| Radboud University Medical Center | Nijmegen | Netherlands |
| FysioHolland Oud Gastel | Oud Gastel | Netherlands |
| Van Broekhoven fysiotherapie | Roosendaal | Netherlands |
| Praktijk Ed van Bruggen | Rotterdam | Netherlands |
| InMotion | Spijkenisse | Netherlands |
| Fysioteam Tegelen | Tegelen | Netherlands |
| Fysiek Vooruit | Teteringen | 4847 NJ | Netherlands |
| Praktijk Prins Hendrikstraat | The Hague | Netherlands |
| Van der Kieft Fysiotherapie | Uden | Netherlands |
| Motion Fysiotherapie & Preventie | Uithoorn | Netherlands |
| Therapiecentrum Veenstade | Vaassen | Netherlands |
| Fysio van Hoof, expertisecentrum Reva Vitaal | Valkenswaard | Netherlands |
| Rembrandt fysiotherapie & revalidatie | Veenendaal | Netherlands |
| Brabantzorg | Veghel | 5467 AN | Netherlands |
| COPD |
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 |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Parkinson's Disease | 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 |
| BG001 | COPD | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| 6MWT | Distance walked during the 6MWT | Mean | Standard Deviation | meter |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Deviation | meter | Week 0, week 5, week 10 and week 15 |
|
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| |||||||||||||||||||||||||||||
| Secondary | Mean Difference in 6MWD of Study Watch | Difference between 6MWD at home and in-clinic Note: not yet reported, data analysis is in progress | Not Posted | Dec 2025 | Week 0 until week 5 | Participants | |||||||||||||||||||||||||||||||||
| Secondary | Change in Physical Capacity | Change in 6MWD from week 5 until week 15 after aerobic exercise capacity training | Posted | Mean | Standard Deviation | meters | Week 5 until week 15 |
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| Secondary | 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 | Not Posted | Dec 2025 | Week 0, Week 5, Week 10, Week 15 | Participants | |||||||||||||||||||||||||||||||||
| Secondary | 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 | Not Posted | Dec 2025 | Week 0 until week 5 | Participants | |||||||||||||||||||||||||||||||||
| Secondary | Change in Gait Speed (10MWT) | The difference in time to complete the 10MWT with and without cognitive task while walking and over time | Posted | Mean | Standard Deviation | seconds | Week 0, Week 5, Week 10, Week 15 |
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| Secondary | 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 | Posted | Mean | Standard Deviation | points | Week 0 and Week 15 |
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| ||||||||||||||||||||||||||||||
| Secondary | 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 | COPD participants did not perform this test, as it is a PD-specific test | Posted | Mean | Standard Deviation | points | Week 0, Week 5, Week 10, Week 15 |
|
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| Secondary | 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 | Not Posted | Dec 2025 | Week 0, Week 5, Week 10, Week 15 | Participants | |||||||||||||||||||||||||||||||||
| Secondary | 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 | Posted | Mean | Standard Deviation | points | Week 0, Week 5, Week 10, Week 15 |
|
| ||||||||||||||||||||||||||||||
| Secondary | 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 | Not Posted | Dec 2025 | Week 0, Week 5, Week 10, Week 15 | Participants | |||||||||||||||||||||||||||||||||
| Secondary | 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 | Not Posted | Dec 2025 | Week 0, Week 5, Week 10, Week 15 | Participants | |||||||||||||||||||||||||||||||||
| Secondary | 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 | COPD participants did not complete this questionnaire, as it is a PD-specific questionnaire | Posted | Mean | Standard Deviation | points | Week 0, Week 5, Week 10, Week 15 |
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| Secondary | 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 | Not Posted | Dec 2025 | Week 0, Week 5, Week 10, Week 15 | Participants | |||||||||||||||||||||||||||||||||
| Secondary | 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 | This questionnaire is not completed by the PD participants, as it is an COPD-specific questionnaire | Posted | Median | Inter-Quartile Range | score on a scale | Week 0, Week 5, Week 10, Week 15 |
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| Secondary | 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. | This test is not completed by the PD participants, as it is a COPD-specific questionnaire. | Posted | Median | Inter-Quartile Range | units on a scale | Week 0, Week 5, Week 10, Week 15 |
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| Secondary | System Usability Scale (SUS) Questionnaire | Usability of the Verily Study Watch. Range 0-13. Higher scores indicate better usability | Not Posted | Week 15 | Participants |
Adverse event data were collected from baseline to study completion
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Parkinson's Disease | 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 | 0 | 89 | 0 | 89 | 0 | 89 |
| EG001 | COPD | 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 | 1 | 65 | 1 | 65 | 0 | 65 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lung cancer stage 4 diagnosis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Drs. D. de Graaf | Radboudumc | +31243613450 | debbie.degraaf@radboudumc.nl |
| Feb 19, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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