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

NCT05756075 | Completed Results DMC

• 1 other identifier: NL78292.091.21
• Study Type: observational
• Target: 154
• Locations: 1 country
• Sites: 28

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.

Conditions

Parkinson Disease; COPD

Keywords

Physical activity; Physical capacity; Walking; Exercise; Wearable sensors; Locomotion; Home-based

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (16)

• Mean Difference in 6MWD of Study Watch

  Week 0 until week 5

• Change in Physical Capacity

  Week 5 until week 15

• Mean Difference in TUG Time

  Week 0, Week 5, Week 10, Week 15

• Mean Difference in TUG Time of Study Watch

  Week 0 until week 5

• Change in Gait Speed (10MWT)

  Week 0, Week 5, Week 10, Week 15

Study Arms (2)

Parkinson's Disease

Behavioral: Aerobic exercise training

COPD

Behavioral: Aerobic exercise training

Interventions

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

COPD; Parkinson's Disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Verily Life Sciences LLC: collaborator

Study Sites (28)

Paca

Aalsmeer, Netherlands

Location

Gezondheidscentrum Marne

Amstelveen, Netherlands

Location

Fysiotherapie Heusdenhout

Breda, Netherlands

Location

Praktijk Graaf Hendrik III Laan

Breda, Netherlands

Location

RevaQ

Breda, Netherlands

Location

Lijf & leven, fit en fysiotherapie

Ede, Netherlands

Location

Fysiotherapie De Hertog

Franeker, Netherlands

Location

Zorggroep Ter Weel

Goes, Netherlands

Location

Fysio Heerde

Heerde, Netherlands

Location

Tigra

Heerenveen, Netherlands

Location

Centra Plaza Fysiotherapie

Lelystad, Netherlands

Location

Fysiotherapie MTC Lopik

Lopik, Netherlands

Location

Vivium Fysiotherapie Naarderheem

Naarden, Netherlands

Location

Manueel Fysiocare

Nieuwegein, Netherlands

Location

Radboud University Medical Center

Nijmegen, Netherlands

Location

FysioHolland Oud Gastel

Oud Gastel, Netherlands

Location

Van Broekhoven fysiotherapie

Roosendaal, Netherlands

Location

Praktijk Ed van Bruggen

Rotterdam, Netherlands

Location

InMotion

Spijkenisse, Netherlands

Location

Fysioteam Tegelen

Tegelen, Netherlands

Location

Fysiek Vooruit

Teteringen, 4847 NJ, Netherlands

Location

Praktijk Prins Hendrikstraat

The Hague, Netherlands

Location

Van der Kieft Fysiotherapie

Uden, Netherlands

Location

Motion Fysiotherapie & Preventie

Uithoorn, Netherlands

Location

Therapiecentrum Veenstade

Vaassen, Netherlands

Location

Fysio van Hoof, expertisecentrum Reva Vitaal

Valkenswaard, Netherlands

Location

Rembrandt fysiotherapie & revalidatie

Veenendaal, Netherlands

Location

Brabantzorg

Veghel, 5467 AN, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 38713508 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Pulmonary Disease, Chronic Obstructive; Motor Activity

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Results Point of Contact

• Title: Drs. D. de Graaf
• Organization: Radboudumc

debbie.degraaf@radboudumc.nl

+31243613450

Study Officials

• Bastiaan R Bloem, MD, PhD.

  Radboudumc department of Neurology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: March 6, 2023
• Study Start: December 23, 2021
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: March 12, 2025
• Results First Posted: March 12, 2025

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: Not decided yet
• Access Criteria: Not decided yet

Locations

NL (28)