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

Parkinson Disease Clinical Trial

— ADAPT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05756075
• Other study ID #: NL78292.091.21
• Status: Completed
• Start date: December 23, 2021
• Est. completion date: November 30, 2023

Study information

• Verified date: December 2022
• Source: Radboud University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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 information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD
• Parkinson Disease

Intervention

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

Locations

Country	Name	City	State
Netherlands	Paca	Aalsmeer
Netherlands	Gezondheidscentrum Marne	Amstelveen
Netherlands	Fysiotherapie Heusdenhout	Breda
Netherlands	Praktijk Graaf Hendrik III Laan	Breda
Netherlands	RevaQ	Breda
Netherlands	Praktijk Prins Hendrikstraat	Den Haag
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
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

Sponsors (2)

Lead Sponsor	Collaborator
Radboud University Medical Center	Verily Life Sciences LLC

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mean difference in 6MWD of Study Watch	Difference between 6MWD at home and in-clinic	Week 0 until week 5
Secondary	Change in physical capacity	Change in 6MWD from week 5 until week 15 after aerobic exercise capacity training	Week 5 until week 15
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	Week 0, Week 5, Week 10, Week 15
Secondary	Mean difference in TUG time of Study Watch	Difference between TUG time at home and in-clinic	Week 0 until week 5
Secondary	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
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	Week 0 and Week 15
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.	Week 0, Week 5, Week 10, Week 15
Secondary	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
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	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.	Week 0, Week 5, Week 10, Week 15
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.	Week 0, Week 5, Week 10, Week 15
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	Week 0, Week 5, Week 10, Week 15
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	Week 0, Week 5, Week 10, Week 15
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	Week 0, Week 5, Week 10, Week 15
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	Week 0, Week 5, Week 10, Week 15
Secondary	System Usability Scale (SUS) questionnaire	Usability of the Verily Study Watch. Range 0-13. Higher scores indicate better usability	Week 15