The Accuracy of Digital Assessment of Performance Trial (ADAPT): Walk Test Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 154
- 试验地点
- 28
- 主要终点
- Mean Difference in Distance Walked During 6MWT
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Mean Difference in Distance Walked During 6MWT
时间窗: Week 0, week 5, week 10 and week 15
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
次要结局
- 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)
- Change in Cognition (MoCA)(Week 0 and Week 15)
- Change in Parkinson's Disease Symptoms (MDS-UPDRS)(Week 0, Week 5, Week 10, Week 15)
- Change in Self-reported Physical Activity Level (LAPAQ)(Week 0, Week 5, Week 10, Week 15)
- Change in Depression and Anxiety (HADS)(Week 0, Week 5, Week 10, Week 15)
- Change in Fatigue (FACIT-F13)(Week 0, Week 5, Week 10, Week 15)
- Change in Sleepiness at Day (ESS)(Week 0, Week 5, Week 10, Week 15)
- Change in Health Related Quality of Life (PDQ-39)(Week 0, Week 5, Week 10, Week 15)
- Change in Quality of Life (EQ-5D-5L)(Week 0, Week 5, Week 10, Week 15)
- Clinical COPD Questionnaire (CCQ)(Week 0, Week 5, Week 10, Week 15)
- Medical Research Council Dyspnea (mMRC)(Week 0, Week 5, Week 10, Week 15)
- System Usability Scale (SUS) Questionnaire(Week 15)