COPD, Parkinson Disease
Conditions
Keywords
Physical activity, Physical capacity, Walking, Exercise, Wearable sensors, Locomotion, Home-based
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.
Detailed 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.
Interventions
BEHAVIORALAerobic 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
Sponsors
Verily Life Sciences LLC
Radboud University Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Difference in Distance Walked During 6MWT | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Physical Capacity | Week 5 until week 15 | Change in 6MWD from week 5 until week 15 after aerobic exercise capacity training |
| Mean Difference in TUG Time | Week 0, Week 5, Week 10, Week 15 | 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 Note: not yet reported, data needs to be analysed |
| Mean Difference in TUG Time of Study Watch | Week 0 until week 5 | Difference between TUG time at home and in-clinic Note: not yet reported, data needs to be analysed s |
| Change in Gait Speed (10MWT) | Week 0, Week 5, Week 10, Week 15 | The difference in time to complete the 10MWT with and without cognitive task while walking and over time |
| Change in Cognition (MoCA) | Week 0 and Week 15 | Change from baseline on the Montreal Cognitive Assessment (MoCA) score at 15 weeks. Range 0-30. Higher scores indicate better cognition |
| Change in Parkinson's Disease Symptoms (MDS-UPDRS) | Week 0, Week 5, Week 10, Week 15 | 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. note: only the difference in score between week 0 and week 15 is reported |
| Change in Self-reported Physical Activity Level (LAPAQ) | Week 0, Week 5, Week 10, Week 15 | Change from baseline on the Longitudinal Aging Study Amsterdam (LASA) physical Activity Questionnaire (LAPAQ) Note: not yet reported, data needs to be analysed |
| Mean Difference in 6MWD of Study Watch | Week 0 until week 5 | Difference between 6MWD at home and in-clinic Note: not yet reported, data analysis is in progress |
| Change in Fatigue (FACIT-F13) | Week 0, Week 5, Week 10, Week 15 | 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. Note: not yet reported, data needs to be analysed |
| Change in Sleepiness at Day (ESS) | Week 0, Week 5, Week 10, Week 15 | Change from baseline on the Epworth Sleepiness Scale at week 5, week 10 and week 15. Range 0-24. Higher scores indicate worse function. Note: not yet reported, data needs to be analysed |
| Change in Health Related Quality of Life (PDQ-39) | Week 0, Week 5, Week 10, Week 15 | 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 Note: only the difference between week 0 and week 15 is reported |
| Change in Quality of Life (EQ-5D-5L) | Week 0, Week 5, Week 10, Week 15 | 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 Note: not yet reported, data data needs to be analysed |
| Clinical COPD Questionnaire (CCQ) | Week 0, Week 5, Week 10, Week 15 | 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 |
| Medical Research Council Dyspnea (mMRC) | Week 0, Week 5, Week 10, Week 15 | Assessment of dyspnea severity at baseline, week 5, week 10 and week 15. Range 0-4. Higher scores indicate worse function This test is only completed by the COPD participants as it is a COPD-specific questionnaire. |
| System Usability Scale (SUS) Questionnaire | Week 15 | Usability of the Verily Study Watch. Range 0-13. Higher scores indicate better usability |
| Change in Depression and Anxiety (HADS) | Week 0, Week 5, Week 10, Week 15 | 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 Note: only the difference between week 0 and week 15 is reported |
Countries
Netherlands
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Parkinson's Disease 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 | 89 |
| COPD 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 | 65 |
| Total | 154 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 16 | 9 |
Baseline characteristics
| Characteristic | Parkinson's Disease | Total | COPD |
|---|---|---|---|
| 6MWT | 413 meter STANDARD_DEVIATION 92 | 393 meter STANDARD_DEVIATION 88 | 366 meter STANDARD_DEVIATION 76 |
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 57 Participants | 106 Participants | 49 Participants |
| Age, Categorical Between 18 and 65 years | 32 Participants | 48 Participants | 16 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 89 Participants | 154 Participants | 65 Participants |
| Sex: Female, Male Female | 27 Participants | 59 Participants | 32 Participants |
| Sex: Female, Male Male | 62 Participants | 95 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 89 | 1 / 65 |
| other Total, other adverse events | 0 / 89 | 0 / 65 |
| serious Total, serious adverse events | 0 / 89 | 1 / 65 |
Outcome results
Primary
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
Time frame: Week 0, week 5, week 10 and week 15
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Parkinson's Disease | Mean Difference in Distance Walked During 6MWT | 33 meter | Standard Deviation 8 |
| COPD | Mean Difference in Distance Walked During 6MWT | 15 meter | Standard Deviation 10 |
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
Time frame: Week 0 and Week 15
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parkinson's Disease | Change in Cognition (MoCA) | Week 15 | 26.1 points | Standard Deviation 3.8 |
| Parkinson's Disease | Change in Cognition (MoCA) | Week 0 | 25.9 points | Standard Deviation 3.8 |
| COPD | Change in Cognition (MoCA) | Week 15 | 25.2 points | Standard Deviation 2.8 |
| COPD | Change in Cognition (MoCA) | Week 0 | 25.7 points | Standard Deviation 2.7 |
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 Note: only the difference between week 0 and week 15 is reported
Time frame: Week 0, Week 5, Week 10, Week 15
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Parkinson's Disease | Change in Depression and Anxiety (HADS) | 0.6 points | Standard Deviation 3.6 |
| COPD | Change in Depression and Anxiety (HADS) | 0.7 points | Standard Deviation 3.7 |
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. Note: not yet reported, data needs to be analysed
Time frame: Week 0, Week 5, Week 10, Week 15
Secondary
Change in Gait Speed (10MWT)
The difference in time to complete the 10MWT with and without cognitive task while walking and over time
Time frame: Week 0, Week 5, Week 10, Week 15
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Parkinson's Disease | Change in Gait Speed (10MWT) | Week 0 | -1.3 seconds | Standard Deviation 2.3 |
| Parkinson's Disease | Change in Gait Speed (10MWT) | Week 5 | -1.2 seconds | Standard Deviation 2.1 |
| Parkinson's Disease | Change in Gait Speed (10MWT) | Week 10 | -1.3 seconds | Standard Deviation 1.9 |
| Parkinson's Disease | Change in Gait Speed (10MWT) | Week 15 | -1.2 seconds | Standard Deviation 1.8 |
| COPD | Change in Gait Speed (10MWT) | Week 15 | -0.7 seconds | Standard Deviation 1.8 |
| COPD | Change in Gait Speed (10MWT) | Week 0 | -1.0 seconds | Standard Deviation 1.9 |
| COPD | Change in Gait Speed (10MWT) | Week 10 | -0.4 seconds | Standard Deviation 0.5 |
| COPD | Change in Gait Speed (10MWT) | Week 5 | -0.56 seconds | Standard Deviation 0.6 |
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 Note: only the difference between week 0 and week 15 is reported
Time frame: Week 0, Week 5, Week 10, Week 15
Population: COPD participants did not complete this questionnaire, as it is a PD-specific questionnaire
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Parkinson's Disease | Change in Health Related Quality of Life (PDQ-39) | 0.88 points | Standard Deviation 15.3 |
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. note: only the difference in score between week 0 and week 15 is reported
Time frame: Week 0, Week 5, Week 10, Week 15
Population: COPD participants did not perform this test, as it is a PD-specific test
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Parkinson's Disease | Change in Parkinson's Disease Symptoms (MDS-UPDRS) | 4.5 points | Standard Deviation 19.2 |
Secondary
Change in Physical Capacity
Change in 6MWD from week 5 until week 15 after aerobic exercise capacity training
Time frame: Week 5 until week 15
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Parkinson's Disease | Change in Physical Capacity | -17.1 meters | Standard Deviation 120.7 |
| COPD | Change in Physical Capacity | -15.4 meters | Standard Deviation 89.1 |
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 Note: not yet reported, data data needs to be analysed
Time frame: 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) Note: not yet reported, data needs to be analysed
Time frame: 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. Note: not yet reported, data needs to be analysed
Time frame: 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
Time frame: Week 0, Week 5, Week 10, Week 15
Population: This questionnaire is not completed by the PD participants, as it is an COPD-specific questionnaire
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| COPD | Clinical COPD Questionnaire (CCQ) | Week 0 | 2 score on a scale |
| COPD | Clinical COPD Questionnaire (CCQ) | Week 5 | 2 score on a scale |
| COPD | Clinical COPD Questionnaire (CCQ) | Week 10 | 2 score on a scale |
| COPD | Clinical COPD Questionnaire (CCQ) | Week 15 | 2 score on a scale |
Secondary
Mean Difference in 6MWD of Study Watch
Difference between 6MWD at home and in-clinic Note: not yet reported, data analysis is in progress
Time frame: Week 0 until week 5
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 Note: not yet reported, data needs to be analysed
Time frame: 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 Note: not yet reported, data needs to be analysed s
Time frame: Week 0 until week 5
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 This test is only completed by the COPD participants as it is a COPD-specific questionnaire.
Time frame: Week 0, Week 5, Week 10, Week 15
Population: This test is not completed by the PD participants, as it is a COPD-specific questionnaire.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| COPD | Medical Research Council Dyspnea (mMRC) | Week 0 | 3 units on a scale |
| COPD | Medical Research Council Dyspnea (mMRC) | Week 5 | 3 units on a scale |
| COPD | Medical Research Council Dyspnea (mMRC) | Week 10 | 3 units on a scale |
| COPD | Medical Research Council Dyspnea (mMRC) | Week 15 | 3 units on a scale |
Secondary
System Usability Scale (SUS) Questionnaire
Usability of the Verily Study Watch. Range 0-13. Higher scores indicate better usability
Time frame: Week 15