N/A
Completed N=154
The ADAPT-study: Measuring Physical Performance Using Wearable Sensors in Parkinson's Disease and COPD (ADAPT)
Source: ClinicalTrials.gov NCT05756075 ↗Enrolled (actual)
154
Serious AEs
0.7%
Results posted
Mar 2025
Primary outcomePrimary: Mean Difference in Distance Walked During 6MWT — 33; 15 meter
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Difference in Distance Walked During 6MWT |
33; 15 | — |
| SECONDARY Mean Difference in 6MWD of Study Watch |
— | — |
| SECONDARY Change in Physical Capacity |
-17.1; -15.4 | — |
| SECONDARY Mean Difference in TUG Time |
— | — |
| SECONDARY Mean Difference in TUG Time of Study Watch |
— | — |
| SECONDARY Change in Gait Speed (10MWT) |
-1.3; -1.0; -1.2; -0.56; -1.3; -0.4 | — |
| SECONDARY Change in Cognition (MoCA) |
25.9; 25.7; 26.1; 25.2 | — |
| SECONDARY Change in Parkinson's Disease Symptoms (MDS-UPDRS) |
4.5 | — |
| SECONDARY Change in Self-reported Physical Activity Level (LAPAQ) |
— | — |
| SECONDARY Change in Depression and Anxiety (HADS) |
0.6; 0.7 | — |
| SECONDARY Change in Fatigue (FACIT-F13) |
— | — |
| SECONDARY Change in Sleepiness at Day (ESS) |
— | — |
| SECONDARY Change in Health Related Quality of Life (PDQ-39) |
0.88 | — |
| SECONDARY Change in Quality of Life (EQ-5D-5L) |
— | — |
| SECONDARY Clinical COPD Questionnaire (CCQ) |
2; 2; 2; 2 | — |
| SECONDARY Medical Research Council Dyspnea (mMRC) |
3; 3; 3; 3 | — |
| SECONDARY System Usability Scale (SUS) Questionnaire |
— | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05756075). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.