Trial Outcomes & Findings for The Cyclical Lower-extremity Exercise for Parkinson's Trial (NCT NCT01636297)

Results Overview

The Movement Disorder Society-Unified Parkinson's disease Rating Scale (MDS-UPDRS) Motor III Score is a subscale of the MDS-UPDRS. The MDS-UPDRS III is the sum of 33 scores that evaluate Parkinson's disease motor symptoms on a scale from 0 to 4 points. A score of 0 indicated no symptom is present and a maximum score of 4 indicates the most severe symptom, the total scale range is 0-132, where higher scores indicate more severe symptoms. The primary outcome is the change in total motor subscale score in the MDS-UPDRS from baseline versus the three end of treatment (EOT) assessments.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

100 participants

Primary outcome timeframe

Change from baseline over 16 weeks

Results posted on

2018-09-26

Participant Flow

Participant milestones

Participant milestones
Measure	Forced Exercise Forced exercise: Exercise on a stationary cycle, controlled by motor , to augment voluntary rate by 35%	Voluntary Exercise Voluntary exercise: Exercise on a stationary bicycle without motor assistance	No Exercise No-exercise/control: No exercise intervention is given. This group serves as a control group.
Overall Study STARTED	40	40	20
Overall Study COMPLETED	36	36	19
Overall Study NOT COMPLETED	4	4	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Cyclical Lower-extremity Exercise for Parkinson's Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Forced Exercise n=40 Participants Forced exercise: Exercise on a stationary bicycle, driven by a motor controlled by an algorithm, to force an individual to pedal faster than their voluntary cadence, 3 times per week for 8 weeks	Voluntary Exercise n=40 Participants Voluntary exercise: Exercise on a stationary bicycle without augmenting cadence 3 times per week for 8 weeks	No Exercise n=20 Participants No-exercise/control: No exercise intervention is given. This group serves as a control group.	Total n=100 Participants Total of all reporting groups
Age, Continuous	63 years STANDARD_DEVIATION 8 • n=5 Participants	61 years STANDARD_DEVIATION 9 • n=7 Participants	65 years STANDARD_DEVIATION 6 • n=5 Participants	63 years STANDARD_DEVIATION 7 • n=4 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	19 Participants n=7 Participants	6 Participants n=5 Participants	42 Participants n=4 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	21 Participants n=7 Participants	14 Participants n=5 Participants	58 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	38 Participants n=5 Participants	40 Participants n=7 Participants	20 Participants n=5 Participants	98 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	36 Participants n=5 Participants	36 Participants n=7 Participants	19 Participants n=5 Participants	91 Participants n=4 Participants

PRIMARY outcome

Timeframe: Change from baseline over 16 weeks

The Movement Disorder Society-Unified Parkinson's disease Rating Scale (MDS-UPDRS) Motor III Score is a subscale of the MDS-UPDRS. The MDS-UPDRS III is the sum of 33 scores that evaluate Parkinson's disease motor symptoms on a scale from 0 to 4 points. A score of 0 indicated no symptom is present and a maximum score of 4 indicates the most severe symptom, the total scale range is 0-132, where higher scores indicate more severe symptoms. The primary outcome is the change in total motor subscale score in the MDS-UPDRS from baseline versus the three end of treatment (EOT) assessments.

Outcome measures

Outcome measures
Measure	Forced Exercise n=36 Participants Forced exercise: Exercise on a stationary bicycle, driven by a motor controlled by an algorithm, to force an individual to pedal faster than their voluntary cadence, 3 times per week for 8 weeks	Voluntary Exercise n=36 Participants Voluntary exercise: Exercise on a stationary bicycle without augmenting cadence 3 times per week for 8 weeks	No Exercise n=19 Participants No-exercise/control: No exercise intervention is given. This group serves as a control group.
MDS-UPDRS Motor III Score	-4.8 change in MDS- UPDRS III score Interval -7.7 to -1.9	-4.9 change in MDS- UPDRS III score Interval -7.8 to -2.0	1.8 change in MDS- UPDRS III score Interval -2.1 to 5.8

PRIMARY outcome

Timeframe: Change from baseline over 16 weeks

The Trail Making test is a test of executive function and the primary outcome is total test time. The total time that it takes to complete the test was recorded at baseline and then after the end of treatment. Test time recording begins with the start of the test and ends when the test is completed. Longer times indicate worse executive function. The outcome is the change in test time on the trail making test from baseline to the end of treatment (EOT) assessment.

Outcome measures

Outcome measures
Measure	Forced Exercise n=35 Participants Forced exercise: Exercise on a stationary bicycle, driven by a motor controlled by an algorithm, to force an individual to pedal faster than their voluntary cadence, 3 times per week for 8 weeks	Voluntary Exercise n=34 Participants Voluntary exercise: Exercise on a stationary bicycle without augmenting cadence 3 times per week for 8 weeks	No Exercise n=19 Participants No-exercise/control: No exercise intervention is given. This group serves as a control group.
Trail Making Test	-3.26 seconds Standard Deviation 4.49	-2.91 seconds Standard Deviation 7.83	-3.8 seconds Standard Deviation 3.36

PRIMARY outcome

Timeframe: Change from baseline to end of treatment

Population: A subgroup of participants from only the exercise groups were analyzed for this outcome measure, as not all participants in this study received functional MRI's. The No Exercise group was not included in this subgroup analysis and did not receive MRI.

The primary outcome measure will number of patients that increased their connection between the motor cortex and the thalamus. The functional connection was assessed using functional magnetic resonance imaging. The outcome measure was change in connectivity from baseline to end of treatment.

Outcome measures

Outcome measures
Measure	Forced Exercise n=6 Participants Forced exercise: Exercise on a stationary bicycle, driven by a motor controlled by an algorithm, to force an individual to pedal faster than their voluntary cadence, 3 times per week for 8 weeks	Voluntary Exercise n=6 Participants Voluntary exercise: Exercise on a stationary bicycle without augmenting cadence 3 times per week for 8 weeks	No Exercise No-exercise/control: No exercise intervention is given. This group serves as a control group.
Number of Participants With Increased Motor Cortex and Thalamus Connectivity	4 Participants	2 Participants	0 Participants

Adverse Events

Forced Exercise

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Voluntary Exercise

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Exercise

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Forced Exercise n=36 participants at risk Forced exercise: Exercise on a stationary cycle that was controlled by a motor to augment voluntary rate by 35%	Voluntary Exercise n=36 participants at risk Voluntary exercise: Exercise on a stationary cycle without motor assistance	No Exercise n=19 participants at risk No-exercise/control: No exercise intervention is given. This group serves as a control group.
Skin and subcutaneous tissue disorders Skin Irritation	2.8% 1/36 • Participants were enrolled for 16 weeks.	0.00% 0/36 • Participants were enrolled for 16 weeks.	0.00% 0/19 • Participants were enrolled for 16 weeks.

Additional Information

Dr. Jay Alberts

Cleveland Clinic

Phone: 216-445-3222

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place