Trial Outcomes & Findings for The ADAPT-study: Measuring Physical Performance Using Wearable Sensors in Parkinson's Disease and COPD (ADAPT) (NCT NCT05756075)
NCT ID: NCT05756075
Last Updated: 2025-03-12
Results Overview
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
COMPLETED
154 participants
Week 0, week 5, week 10 and week 15
2025-03-12
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
89
|
65
|
|
Overall Study
COMPLETED
|
73
|
56
|
|
Overall Study
NOT COMPLETED
|
16
|
9
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
16
|
9
|
Baseline Characteristics
The ADAPT-study: Measuring Physical Performance Using Wearable Sensors in Parkinson's Disease and COPD (ADAPT)
Baseline characteristics by cohort
| Measure |
Parkinson's Disease
n=89 Participants
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
|
COPD
n=65 Participants
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
|
Total
n=154 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
57 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
106 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
95 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
89 Participants
n=99 Participants
|
65 Participants
n=107 Participants
|
154 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
6MWT
|
413 meter
STANDARD_DEVIATION 92 • n=99 Participants
|
366 meter
STANDARD_DEVIATION 76 • n=107 Participants
|
393 meter
STANDARD_DEVIATION 88 • n=206 Participants
|
PRIMARY outcome
Timeframe: Week 0, week 5, week 10 and week 15Mean 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
Outcome measures
| Measure |
Parkinson's Disease
n=89 Participants
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
|
COPD
n=65 Participants
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
|
|---|---|---|
|
Mean Difference in Distance Walked During 6MWT
|
33 meter
Standard Deviation 8
|
15 meter
Standard Deviation 10
|
SECONDARY outcome
Timeframe: Week 0 until week 5Difference between 6MWD at home and in-clinic Note: not yet reported, data analysis is in progress
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 5 until week 15Change in 6MWD from week 5 until week 15 after aerobic exercise capacity training
Outcome measures
| Measure |
Parkinson's Disease
n=89 Participants
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
|
COPD
n=65 Participants
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
|
|---|---|---|
|
Change in Physical Capacity
|
-17.1 meters
Standard Deviation 120.7
|
-15.4 meters
Standard Deviation 89.1
|
SECONDARY outcome
Timeframe: Week 0, Week 5, Week 10, Week 15Mean 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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 0 until week 5Difference between TUG time at home and in-clinic Note: not yet reported, data needs to be analysed s
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 0, Week 5, Week 10, Week 15The difference in time to complete the 10MWT with and without cognitive task while walking and over time
Outcome measures
| Measure |
Parkinson's Disease
n=89 Participants
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
|
COPD
n=65 Participants
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
|
|---|---|---|
|
Change in Gait Speed (10MWT)
Week 0
|
-1.3 seconds
Standard Deviation 2.3
|
-1.0 seconds
Standard Deviation 1.9
|
|
Change in Gait Speed (10MWT)
Week 5
|
-1.2 seconds
Standard Deviation 2.1
|
-0.56 seconds
Standard Deviation 0.6
|
|
Change in Gait Speed (10MWT)
Week 10
|
-1.3 seconds
Standard Deviation 1.9
|
-0.4 seconds
Standard Deviation 0.5
|
|
Change in Gait Speed (10MWT)
Week 15
|
-1.2 seconds
Standard Deviation 1.8
|
-0.7 seconds
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: Week 0 and Week 15Change from baseline on the Montreal Cognitive Assessment (MoCA) score at 15 weeks. Range 0-30. Higher scores indicate better cognition
Outcome measures
| Measure |
Parkinson's Disease
n=89 Participants
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
|
COPD
n=65 Participants
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
|
|---|---|---|
|
Change in Cognition (MoCA)
Week 0
|
25.9 points
Standard Deviation 3.8
|
25.7 points
Standard Deviation 2.7
|
|
Change in Cognition (MoCA)
Week 15
|
26.1 points
Standard Deviation 3.8
|
25.2 points
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: Week 0, Week 5, Week 10, Week 15Population: COPD participants did not perform this test, as it is a PD-specific test
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
Outcome measures
| Measure |
Parkinson's Disease
n=89 Participants
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
|
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
|
|---|---|---|
|
Change in Parkinson's Disease Symptoms (MDS-UPDRS)
|
4.5 points
Standard Deviation 19.2
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 5, Week 10, Week 15Change from baseline on the Longitudinal Aging Study Amsterdam (LASA) physical Activity Questionnaire (LAPAQ) Note: not yet reported, data needs to be analysed
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 0, Week 5, Week 10, Week 15Change 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
Outcome measures
| Measure |
Parkinson's Disease
n=89 Participants
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
|
COPD
n=65 Participants
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
|
|---|---|---|
|
Change in Depression and Anxiety (HADS)
|
0.6 points
Standard Deviation 3.6
|
0.7 points
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: Week 0, Week 5, Week 10, Week 15Change 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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 0, Week 5, Week 10, Week 15Change 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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 0, Week 5, Week 10, Week 15Population: COPD participants did not complete this questionnaire, as it is a PD-specific questionnaire
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
Outcome measures
| Measure |
Parkinson's Disease
n=89 Participants
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
|
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
|
|---|---|---|
|
Change in Health Related Quality of Life (PDQ-39)
|
0.88 points
Standard Deviation 15.3
|
—
|
SECONDARY outcome
Timeframe: Week 0, Week 5, Week 10, Week 15Change 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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 0, Week 5, Week 10, Week 15Population: This questionnaire is not completed by the PD participants, as it is an COPD-specific questionnaire
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
Outcome measures
| Measure |
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
|
COPD
n=65 Participants
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
|
|---|---|---|
|
Clinical COPD Questionnaire (CCQ)
Week 0
|
—
|
2 score on a scale
Interval 2.0 to 2.0
|
|
Clinical COPD Questionnaire (CCQ)
Week 5
|
—
|
2 score on a scale
Interval 1.0 to 2.0
|
|
Clinical COPD Questionnaire (CCQ)
Week 10
|
—
|
2 score on a scale
Interval 1.0 to 2.0
|
|
Clinical COPD Questionnaire (CCQ)
Week 15
|
—
|
2 score on a scale
Interval 1.0 to 2.0
|
SECONDARY outcome
Timeframe: Week 0, Week 5, Week 10, Week 15Population: This test is not completed by the PD participants, as it is a COPD-specific questionnaire.
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.
Outcome measures
| Measure |
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
|
COPD
n=65 Participants
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
|
|---|---|---|
|
Medical Research Council Dyspnea (mMRC)
Week 10
|
—
|
3 units on a scale
Interval 2.0 to 3.0
|
|
Medical Research Council Dyspnea (mMRC)
Week 0
|
—
|
3 units on a scale
Interval 2.0 to 3.0
|
|
Medical Research Council Dyspnea (mMRC)
Week 5
|
—
|
3 units on a scale
Interval 2.0 to 3.0
|
|
Medical Research Council Dyspnea (mMRC)
Week 15
|
—
|
3 units on a scale
Interval 2.0 to 3.0
|
SECONDARY outcome
Timeframe: Week 15Usability of the Verily Study Watch. Range 0-13. Higher scores indicate better usability
Outcome measures
Outcome data not reported
Adverse Events
Parkinson's Disease
COPD
Serious adverse events
| Measure |
Parkinson's Disease
n=89 participants at risk
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
|
COPD
n=65 participants at risk
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
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Lung cancer stage 4 diagnosis
|
0.00%
0/89 • Adverse event data were collected from baseline to study completion
|
1.5%
1/65 • Adverse event data were collected from baseline to study completion
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place