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

Radboud University Medical Center

Status

Completed

Conditions

Parkinson Disease

COPD

Treatments

Behavioral: Aerobic exercise training

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT05756075

NL78292.091.21

Details and patient eligibility

About

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.

Full 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.

Enrollment

154 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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