Trial Outcomes & Findings for Pragmatic Cyclical Lower Extremity Exercise Trial for Parkinson's Disease (NCT NCT04000360)
NCT ID: NCT04000360
Last Updated: 2025-06-18
Results Overview
Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III: Motor Examination score, measured off medication. Range of scores is 0 to 132, with lower score indicating better motor function.
COMPLETED
NA
256 participants
Baseline, 6 months, 12 months
2025-06-18
Participant Flow
Participant milestones
| Measure |
Aerobic Exercise Group
Aerobic Exercise on a Stationary Bike
|
Usual and Customary Care Group
Continue regular activity. No aerobic exercise intervention.
|
|---|---|---|
|
Overall Study
STARTED
|
129
|
127
|
|
Overall Study
COMPLETED
|
123
|
123
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
All observed data are summarized; 5 participants, 3 in the aerobic exercise (AE) and 2 in the usual care (UC) arm, withdrew prior to initiating randomized treatment and follow-up, of whom 4 had not yet completed the baseline MDS-UPDRS III. One participant was withdrawn by the study PI due to periodic atrial fibrillation, 2 withdrew due to COVID-19 pandemic-related logistical issues and safety concerns, and 2 withdrew due to dissatisfaction with their randomized usual care assignments.
Baseline characteristics by cohort
| Measure |
High-Intensity Aerobic Exercise Group
n=129 Participants
Mild to moderate Parkinson's disease patients receiving a Peloton indoor cycle and a heart rate monitor strap delivered to the home, and asked to cycle 3x/week for 12 months with goal of progressing to 45 minute sessions with the heart rate monitor at an aerobic intensity between 60-80% of heart rate reserve with a target cadence between 80-90 revolutions per minute (RPMs). Participants also receive and are asked to wear activity monitors throughout the day to monitor daily. activity levels. Participants also receive biweekly telephone calls to review electronic activity monitoring and exercise data, monitor falls and adverse events, and for guidance on progressing their cycling exercise sessions. See Alberts JL et al., Physical Therapy, 2021;101:1-10.
|
Usual and Customary Care Group
n=127 Participants
Mild to moderate Parkinson's disease patients receiving no active exercise intervention through the research. These participants continued to receive usual and customary care (UCC) for their Parkinson's disease during the 12 month follow-up period. Participants receive and are asked to wear activity monitors throughout the day to monitor daily activity levels, and not to commence a cycling exercise program for the duration of the 12 month follow-up period. Participants also receive biweekly telephone calls to review electronic activity monitoring data, monitor falls and adverse events, and to provide them similar contact time as for the active exercise group.
|
Total
n=256 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=129 Participants
|
0 Participants
n=127 Participants
|
0 Participants
n=256 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
70 Participants
n=129 Participants
|
53 Participants
n=127 Participants
|
123 Participants
n=256 Participants
|
|
Age, Categorical
>=65 years
|
59 Participants
n=129 Participants
|
74 Participants
n=127 Participants
|
133 Participants
n=256 Participants
|
|
Age, Continuous
|
63.1 years
STANDARD_DEVIATION 8.6 • n=129 Participants
|
65.2 years
STANDARD_DEVIATION 8.2 • n=127 Participants
|
64.2 years
STANDARD_DEVIATION 8.5 • n=256 Participants
|
|
Sex/Gender, Customized
Sex/Prefer not to answer
|
1 Participants
n=129 Participants
|
0 Participants
n=127 Participants
|
1 Participants
n=256 Participants
|
|
Sex/Gender, Customized
Male
|
86 Participants
n=129 Participants
|
84 Participants
n=127 Participants
|
170 Participants
n=256 Participants
|
|
Sex/Gender, Customized
Female
|
42 Participants
n=129 Participants
|
43 Participants
n=127 Participants
|
85 Participants
n=256 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=129 Participants
|
2 Participants
n=127 Participants
|
6 Participants
n=256 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
125 Participants
n=129 Participants
|
125 Participants
n=127 Participants
|
250 Participants
n=256 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=129 Participants
|
0 Participants
n=127 Participants
|
0 Participants
n=256 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=129 Participants
|
1 Participants
n=127 Participants
|
1 Participants
n=256 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=129 Participants
|
1 Participants
n=127 Participants
|
3 Participants
n=256 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=129 Participants
|
0 Participants
n=127 Participants
|
0 Participants
n=256 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=129 Participants
|
1 Participants
n=127 Participants
|
4 Participants
n=256 Participants
|
|
Race (NIH/OMB)
White
|
123 Participants
n=129 Participants
|
121 Participants
n=127 Participants
|
244 Participants
n=256 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=129 Participants
|
3 Participants
n=127 Participants
|
4 Participants
n=256 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=129 Participants
|
0 Participants
n=127 Participants
|
0 Participants
n=256 Participants
|
|
Region of Enrollment
United States
|
129 participants
n=129 Participants
|
127 participants
n=127 Participants
|
256 participants
n=256 Participants
|
|
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (Motor Examination)
|
38.5 units on a scale
STANDARD_DEVIATION 15.6 • n=127 Participants • All observed data are summarized; 5 participants, 3 in the aerobic exercise (AE) and 2 in the usual care (UC) arm, withdrew prior to initiating randomized treatment and follow-up, of whom 4 had not yet completed the baseline MDS-UPDRS III. One participant was withdrawn by the study PI due to periodic atrial fibrillation, 2 withdrew due to COVID-19 pandemic-related logistical issues and safety concerns, and 2 withdrew due to dissatisfaction with their randomized usual care assignments.
|
36.9 units on a scale
STANDARD_DEVIATION 14.2 • n=125 Participants • All observed data are summarized; 5 participants, 3 in the aerobic exercise (AE) and 2 in the usual care (UC) arm, withdrew prior to initiating randomized treatment and follow-up, of whom 4 had not yet completed the baseline MDS-UPDRS III. One participant was withdrawn by the study PI due to periodic atrial fibrillation, 2 withdrew due to COVID-19 pandemic-related logistical issues and safety concerns, and 2 withdrew due to dissatisfaction with their randomized usual care assignments.
|
37.7 units on a scale
STANDARD_DEVIATION 14.9 • n=252 Participants • All observed data are summarized; 5 participants, 3 in the aerobic exercise (AE) and 2 in the usual care (UC) arm, withdrew prior to initiating randomized treatment and follow-up, of whom 4 had not yet completed the baseline MDS-UPDRS III. One participant was withdrawn by the study PI due to periodic atrial fibrillation, 2 withdrew due to COVID-19 pandemic-related logistical issues and safety concerns, and 2 withdrew due to dissatisfaction with their randomized usual care assignments.
|
|
Clinical Site
Cleveland Clinic
|
66 Participants
n=129 Participants
|
65 Participants
n=127 Participants
|
131 Participants
n=256 Participants
|
|
Clinical Site
University of Utah
|
63 Participants
n=129 Participants
|
62 Participants
n=127 Participants
|
125 Participants
n=256 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 months, 12 monthsPopulation: Means and standard deviations are for the observed data, without imputation of missing data due to baseline or subsequent dropouts. Analytic modeling results reported below are based on the full intention-to-treat population, with missing data multiply-imputed.
Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III: Motor Examination score, measured off medication. Range of scores is 0 to 132, with lower score indicating better motor function.
Outcome measures
| Measure |
Aerobic Exercise Group
n=129 Participants
Aerobic Exercise on a Stationary Bike
|
Usual and Customary Care Group
n=127 Participants
Continue regular activity. No aerobic exercise intervention.
|
|---|---|---|
|
Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III: Motor Examination Score
6 months
|
35.9 Score on a scale
Standard Deviation 14.1
|
38.8 Score on a scale
Standard Deviation 15.7
|
|
Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III: Motor Examination Score
Baseline
|
38.5 Score on a scale
Standard Deviation 15.6
|
36.9 Score on a scale
Standard Deviation 14.2
|
|
Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III: Motor Examination Score
12 months
|
37.1 Score on a scale
Standard Deviation 13.7
|
40.5 Score on a scale
Standard Deviation 16.4
|
SECONDARY outcome
Timeframe: Baseline, 6 months, 12 monthsPopulation: Medians and interquartile ranges are for the observed data, without imputation of missing data due to baseline or subsequent dropouts. Analytic results reported below are based on the full intention-to-treat population, with missing data multiply-imputed.
The 10 Meter Walk Test (10MWT) evaluates gait speed similarly in separate trials with the participant instructed to walk at comfortable and fast pace, and velocity timed over the middle six meters. This outcome is the velocity (meters/second) with instructions to walk at a comfortable pace, performed off medication. Higher velocities indicate better motor function.
Outcome measures
| Measure |
Aerobic Exercise Group
n=129 Participants
Aerobic Exercise on a Stationary Bike
|
Usual and Customary Care Group
n=127 Participants
Continue regular activity. No aerobic exercise intervention.
|
|---|---|---|
|
10 Meter Walk Test (10MWT) Comfortable Pace Velocity
Baseline
|
1.22 meters/second
Interval 1.07 to 1.39
|
1.26 meters/second
Interval 1.1 to 1.38
|
|
10 Meter Walk Test (10MWT) Comfortable Pace Velocity
6 months
|
1.23 meters/second
Interval 1.09 to 1.39
|
1.25 meters/second
Interval 1.08 to 1.36
|
|
10 Meter Walk Test (10MWT) Comfortable Pace Velocity
12 months
|
1.24 meters/second
Interval 1.08 to 1.39
|
1.24 meters/second
Interval 1.06 to 1.38
|
SECONDARY outcome
Timeframe: Baseline, 6 months, 12 monthsPopulation: Means and standard deviations are for the observed data, without imputation of missing data due to baseline or subsequent dropouts. Analytic results reported below are based on the full intention-to-treat population, with missing data multiply-imputed.
The 10 Meter Walk Test (10MWT) evaluates gait speed similarly in separate trials with the participant instructed to walk at comfortable and fast pace, and velocity timed over the middle six meters. This outcome is the velocity (meters/second) with instructions to walk at a fast pace, performed off medication. Higher velocities indicate better motor function.
Outcome measures
| Measure |
Aerobic Exercise Group
n=129 Participants
Aerobic Exercise on a Stationary Bike
|
Usual and Customary Care Group
n=127 Participants
Continue regular activity. No aerobic exercise intervention.
|
|---|---|---|
|
10 Meter Walk Test (10MWT) Fast Pace Velocity
Baseline
|
1.66 meters/second
Standard Deviation 0.34
|
1.67 meters/second
Standard Deviation 0.33
|
|
10 Meter Walk Test (10MWT) Fast Pace Velocity
6 months
|
1.67 meters/second
Standard Deviation 0.35
|
1.64 meters/second
Standard Deviation 0.36
|
|
10 Meter Walk Test (10MWT) Fast Pace Velocity
12 months
|
1.67 meters/second
Standard Deviation 0.36
|
1.64 meters/second
Standard Deviation 0.39
|
SECONDARY outcome
Timeframe: Baseline, 6 months, 12 monthsPopulation: Medians and interquartile ranges are reported for the observed data, without imputation of missing data due to baseline or subsequent dropouts. Analytic modeling results reported below are based on the full intention-to-treat population, with missing data multiply-imputed.
iPad-facilitated Timed Up and Go Test duration, measured off medication. The Timed "Up \& Go" (TUG) Test requires an individual to (1) stand from a chair, (2) ambulate 3 m, (3) turn 180 degrees, (4) ambulate back to the chair, and (5) turn and sit. To perform an instrumented TUG, an Apple iPad is attached to the individual's waist (sacral level) via an adjustable belt. This outcome is the total time to complete this test, in seconds, measured off medication. Lower times indicate better motor function.
Outcome measures
| Measure |
Aerobic Exercise Group
n=129 Participants
Aerobic Exercise on a Stationary Bike
|
Usual and Customary Care Group
n=127 Participants
Continue regular activity. No aerobic exercise intervention.
|
|---|---|---|
|
Timed Up and Go (TUG) Test Duration
Baseline
|
9.9 seconds
Interval 8.5 to 11.7
|
10.0 seconds
Interval 8.6 to 11.7
|
|
Timed Up and Go (TUG) Test Duration
6 months
|
10.4 seconds
Interval 8.7 to 11.5
|
10.3 seconds
Interval 8.9 to 12.0
|
|
Timed Up and Go (TUG) Test Duration
12 months
|
9.9 seconds
Interval 8.7 to 11.9
|
10.3 seconds
Interval 8.8 to 12.1
|
SECONDARY outcome
Timeframe: Baseline, 6 months, 12 monthsPopulation: Means and standard deviations are for the observed data, without imputation of missing data due to baseline or subsequent dropouts. Analytic results reported below are based on the full intention-to-treat population, with missing data multiply-imputed.
iPad-facilitated Timed Up and Go Test mean turning velocity, measured off medication. The Timed "Up \& Go" (TUG) Test requires an individual to (1) stand from a chair, (2) ambulate 3 m, (3) turn 180 degrees, (4) ambulate back to the chair, and (5) turn and sit. To perform an instrumented TUG, an Apple iPad is attached to the individual's waist (sacral level) via an adjustable belt. This outcome is the mean velocity during performance of step (3), turn 180 degrees, in degrees/second, measured off medication. Higher turn velocities indicate better motor function.
Outcome measures
| Measure |
Aerobic Exercise Group
n=127 Participants
Aerobic Exercise on a Stationary Bike
|
Usual and Customary Care Group
n=125 Participants
Continue regular activity. No aerobic exercise intervention.
|
|---|---|---|
|
Timed Up and Go (TUG) Test Turning Velocity
Baseline
|
77.3 degrees/second
Standard Deviation 19.0
|
78.5 degrees/second
Standard Deviation 16.6
|
|
Timed Up and Go (TUG) Test Turning Velocity
6 months
|
76.3 degrees/second
Standard Deviation 18.0
|
74.5 degrees/second
Standard Deviation 18.6
|
|
Timed Up and Go (TUG) Test Turning Velocity
12 months
|
77.1 degrees/second
Standard Deviation 18.5
|
76.8 degrees/second
Standard Deviation 18.9
|
SECONDARY outcome
Timeframe: Baseline, 6 months, 12 monthsPopulation: Medians and interquartile ranges are for the observed data, without imputation of missing data due to baseline or subsequent dropouts. Analytic results reported below are based on the full intention-to-treat population, with missing data multiply-imputed.
Manual Dexterity Test time to completion in seconds, measured off medication. This test is an electronic (iPad-based), modified version of the 9-hole peg test, where an individual is required to grasp, transfer, and release pegs into a 3×3 grid. Participants are asked to grasp and place pegs into holes, and then to return them to their starting locations, as rapidly as possible. Completion times for two repetitions conducted with each hand were averaged. Shorter completion times indicate better motor function.
Outcome measures
| Measure |
Aerobic Exercise Group
n=129 Participants
Aerobic Exercise on a Stationary Bike
|
Usual and Customary Care Group
n=127 Participants
Continue regular activity. No aerobic exercise intervention.
|
|---|---|---|
|
Manual Dexterity Test Completion Time
Baseline
|
26.4 Time (seconds) to completion
Interval 22.7 to 30.2
|
26.1 Time (seconds) to completion
Interval 23.7 to 29.1
|
|
Manual Dexterity Test Completion Time
6 months
|
26.4 Time (seconds) to completion
Interval 23.9 to 30.3
|
26.0 Time (seconds) to completion
Interval 23.7 to 29.4
|
|
Manual Dexterity Test Completion Time
12 months
|
26.1 Time (seconds) to completion
Interval 23.2 to 30.3
|
26.5 Time (seconds) to completion
Interval 23.0 to 29.7
|
SECONDARY outcome
Timeframe: Baseline, 6 months, 12 monthsPopulation: Medians and interquartile ranges are for the observed data, without imputation of missing data due to baseline or subsequent dropouts. Analytic results reported below are based on the full intention-to-treat population, with missing data multiply-imputed.
The Processing Speed Test is a self-administered electronic (iPad) facilitated symbol-number matching task that is similar to the Symbol Digital Modalities Test. Participants are shown a table with numerical labels for 9 disparate symbols, and a second table with a row of such symbols and a blank row beneath it, and asked to complete the second table with the numbers from the first table corresponding to each symbol in the second. When the table is completed, additional tables are shown. The response recorded is the number of correct matches of symbols with numbers in 120 seconds, measured off medication. Higher values indicate faster neural processing.
Outcome measures
| Measure |
Aerobic Exercise Group
n=129 Participants
Aerobic Exercise on a Stationary Bike
|
Usual and Customary Care Group
n=127 Participants
Continue regular activity. No aerobic exercise intervention.
|
|---|---|---|
|
Processing Speed Test Match Score
Baseline
|
45.0 Correct symbol/number matches
Interval 39.0 to 51.0
|
44.0 Correct symbol/number matches
Interval 38.0 to 49.0
|
|
Processing Speed Test Match Score
6 month
|
46.0 Correct symbol/number matches
Interval 37.5 to 51.0
|
45.0 Correct symbol/number matches
Interval 37.0 to 49.0
|
|
Processing Speed Test Match Score
12 month
|
44.0 Correct symbol/number matches
Interval 37.0 to 53.0
|
45.0 Correct symbol/number matches
Interval 37.0 to 53.0
|
SECONDARY outcome
Timeframe: Baseline, 6 months, 12 monthsPopulation: Medians and interquartile ranges are for the observed data, without imputation of missing data due to baseline or subsequent dropouts. Analytic results reported below are based on the full intention-to-treat population, with missing data multiply-imputed.
Participants completed iPad versions of Trail Making Tests A and B (TMT A and B, respectively), with durations in seconds recorded for each. TMT A, considered predominantly a motor task, requires the participant to use a stylus to connect dots in ascending numeric order (1-2-3-4 . . . ). The TMT B, requires the participant to connect dots in an ascending and alternating alpha and numeric order (1-A-2-B . . . .). The total times to complete each of the TMT A and B tasks are automatically recorded by the iPad. This outcome is the (unitless) ratio of the duration to complete Trail Making Test B to the duration to complete Trail Making Test A, reflecting the cognitive burden of visual attention and set-switching, measured off medication. Higher values reflect greater relative burden of the additional cognitive component.
Outcome measures
| Measure |
Aerobic Exercise Group
n=129 Participants
Aerobic Exercise on a Stationary Bike
|
Usual and Customary Care Group
n=127 Participants
Continue regular activity. No aerobic exercise intervention.
|
|---|---|---|
|
Trail Making Test (TMT) B to A Duration Ratio
Baseline
|
1.58 unitless ratio
Interval 1.22 to 1.93
|
1.55 unitless ratio
Interval 1.23 to 2.11
|
|
Trail Making Test (TMT) B to A Duration Ratio
6 months
|
1.51 unitless ratio
Interval 1.19 to 2.14
|
1.52 unitless ratio
Interval 1.19 to 2.11
|
|
Trail Making Test (TMT) B to A Duration Ratio
12 months
|
1.44 unitless ratio
Interval 1.14 to 1.79
|
1.52 unitless ratio
Interval 1.21 to 1.98
|
SECONDARY outcome
Timeframe: Baseline, 6 months, 12 monthsPopulation: Medians and quartiles are for the observed data, without imputation of missing data due to baseline or subsequent dropouts. Analytic modeling results reported below are based on the full intention-to-treat population, with missing data multiply-imputed.
Electronics-based test of episodic memory performed on an iPad, reported as number of correctly recalled symbols arrayed on a grid, with values ranging from 0 to 70 and higher numbers reflective of better memory, measured off medication.
Outcome measures
| Measure |
Aerobic Exercise Group
n=129 Participants
Aerobic Exercise on a Stationary Bike
|
Usual and Customary Care Group
n=127 Participants
Continue regular activity. No aerobic exercise intervention.
|
|---|---|---|
|
Visual Memory Test Symbol Recall Score
12 month
|
57.5 Number correct
Interval 46.0 to 63.0
|
52 Number correct
Interval 45.0 to 62.0
|
|
Visual Memory Test Symbol Recall Score
Baseline
|
49 Number correct
Interval 39.0 to 59.0
|
48 Number correct
Interval 35.0 to 58.0
|
|
Visual Memory Test Symbol Recall Score
6 month
|
56 Number correct
Interval 43.0 to 64.0
|
54 Number correct
Interval 44.0 to 62.0
|
Adverse Events
Aerobic Exercise Group
Usual and Customary Care Group
Serious adverse events
| Measure |
Aerobic Exercise Group
n=129 participants at risk
Aerobic Exercise on a Stationary Bike
|
Usual and Customary Care Group
n=127 participants at risk
Continue regular activity. No aerobic exercise intervention.
|
|---|---|---|
|
Cardiac disorders
Cardiac Disorders
|
0.78%
1/129 • 12 Months
|
1.6%
2/127 • 12 Months
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
0.78%
1/129 • 12 Months
|
0.79%
1/127 • 12 Months
|
|
Infections and infestations
Infections and infestations
|
1.6%
2/129 • 12 Months
|
2.4%
3/127 • 12 Months
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
1.6%
2/129 • 12 Months
|
3.1%
4/127 • 12 Months
|
|
Psychiatric disorders
Psychiatric disorder
|
0.78%
1/129 • 12 Months
|
0.00%
0/127 • 12 Months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
0.00%
0/129 • 12 Months
|
0.79%
1/127 • 12 Months
|
|
Surgical and medical procedures
Surgical and medical procedure
|
2.3%
3/129 • 12 Months
|
1.6%
2/127 • 12 Months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder
|
0.78%
1/129 • 12 Months
|
0.79%
1/127 • 12 Months
|
|
Nervous system disorders
Nervous System Disorder
|
0.78%
1/129 • 12 Months
|
1.6%
2/127 • 12 Months
|
|
Renal and urinary disorders
Renal and urinary disorders
|
0.78%
1/129 • 12 Months
|
0.79%
1/127 • 12 Months
|
Other adverse events
| Measure |
Aerobic Exercise Group
n=129 participants at risk
Aerobic Exercise on a Stationary Bike
|
Usual and Customary Care Group
n=127 participants at risk
Continue regular activity. No aerobic exercise intervention.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and Connective Tissue Disorders
|
20.9%
27/129 • 12 Months
|
0.00%
0/127 • 12 Months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place