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

Recruitment status

COMPLETED

Target enrollment

154 participants

Primary outcome timeframe

Week 0, week 5, week 10 and week 15

Results posted on

2025-03-12

Participant Flow

Participant milestones

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

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

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 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

Outcome measures

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 5

Difference 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 15

Change in 6MWD from week 5 until week 15 after aerobic exercise capacity training

Outcome measures

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 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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 0 until week 5

Difference 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 15

The difference in time to complete the 10MWT with and without cognitive task while walking and over time

Outcome measures

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 15

Change from baseline on the Montreal Cognitive Assessment (MoCA) score at 15 weeks. Range 0-30. Higher scores indicate better cognition

Outcome measures

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 15

Population: 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

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 15

Change 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 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

Outcome measures

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 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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 0, Week 5, Week 10, Week 15

Population: 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

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 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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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

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

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 15

Population: 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

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 15

Usability of the Verily Study Watch. Range 0-13. Higher scores indicate better usability

Outcome measures

Outcome data not reported

Adverse Events

Parkinson's Disease

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

COPD

Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths

Serious adverse events

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

Drs. D. de Graaf

Radboudumc

Phone: +31243613450

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place