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The Cyclical Lower-extremity Exercise for Parkinson's Trial (CYCLE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01636297
Recruitment Status : Completed
First Posted : July 10, 2012
Results First Posted : September 26, 2018
Last Update Posted : September 26, 2018
Sponsor:
Information provided by (Responsible Party):
Jay Alberts, The Cleveland Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Parkinson's Disease
Interventions Behavioral: Forced exercise
Behavioral: Voluntary exercise
Enrollment 100
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Forced Exercise Voluntary Exercise No Exercise
Hide Arm/Group Description Forced exercise: Exercise on a stationary cycle, controlled by motor , to augment voluntary rate by 35% Voluntary exercise: Exercise on a stationary bicycle without motor assistance No-exercise/control: No exercise intervention is given. This group serves as a control group.
Period Title: Overall Study
Started 40 40 20
Completed 36 36 19
Not Completed 4 4 1
Arm/Group Title Forced Exercise Voluntary Exercise No Exercise Total
Hide Arm/Group Description 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: Exercise on a stationary bicycle without augmenting cadence 3 times per week for 8 weeks No-exercise/control: No exercise intervention is given. This group serves as a control group. Total of all reporting groups
Overall Number of Baseline Participants 40 40 20 100
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 40 participants 40 participants 20 participants 100 participants
63  (8) 61  (9) 65  (6) 63  (7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 20 participants 100 participants
Female
17
  42.5%
19
  47.5%
6
  30.0%
42
  42.0%
Male
23
  57.5%
21
  52.5%
14
  70.0%
58
  58.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 40 participants 40 participants 20 participants 100 participants
Hispanic or Latino
2
   5.0%
0
   0.0%
0
   0.0%
2
   2.0%
Not Hispanic or Latino
38
  95.0%
40
 100.0%
20
 100.0%
98
  98.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 40 participants 40 participants 20 participants 100 participants
36
  90.0%
36
  90.0%
19
  95.0%
91
  91.0%
1.Primary Outcome
Title MDS-UPDRS Motor III Score
Hide Description 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.
Time Frame Change from baseline over 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Forced Exercise Voluntary Exercise No Exercise
Hide Arm/Group Description:
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: Exercise on a stationary bicycle without augmenting cadence 3 times per week for 8 weeks
No-exercise/control: No exercise intervention is given. This group serves as a control group.
Overall Number of Participants Analyzed 36 36 19
Mean (95% Confidence Interval)
Unit of Measure: change in MDS- UPDRS III score
-4.8
(-7.7 to -1.9)
-4.9
(-7.8 to -2.0)
1.8
(-2.1 to 5.8)
2.Primary Outcome
Title Trail Making Test
Hide Description 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.
Time Frame Change from baseline over 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Forced Exercise Voluntary Exercise No Exercise
Hide Arm/Group Description:
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: Exercise on a stationary bicycle without augmenting cadence 3 times per week for 8 weeks
No-exercise/control: No exercise intervention is given. This group serves as a control group.
Overall Number of Participants Analyzed 35 34 19
Mean (Standard Deviation)
Unit of Measure: seconds
-3.26  (4.49) -2.91  (7.83) -3.8  (3.36)
3.Primary Outcome
Title Number of Participants With Increased Motor Cortex and Thalamus Connectivity
Hide Description 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.
Time Frame Change from baseline to end of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Forced Exercise Voluntary Exercise No Exercise
Hide Arm/Group Description:
Forced exercise: Exercise on a stationary cycle, controlled by a motor to augment voluntary rate by 35%
Voluntary exercise: Exercise on a stationary cycle without motor assistance
No-exercise/control: No exercise intervention is given. This group serves as a control group.
Overall Number of Participants Analyzed 6 6 0
Measure Type: Count of Participants
Unit of Measure: Participants
4
  66.7%
2
  33.3%
 0
Time Frame Participants were enrolled for 16 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Forced Exercise Voluntary Exercise No Exercise
Hide Arm/Group Description Forced exercise: Exercise on a stationary cycle that was controlled by a motor to augment voluntary rate by 35% Voluntary exercise: Exercise on a stationary cycle without motor assistance No-exercise/control: No exercise intervention is given. This group serves as a control group.
All-Cause Mortality
Forced Exercise Voluntary Exercise No Exercise
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/36 (0.00%)   0/36 (0.00%)   0/19 (0.00%) 
Hide Serious Adverse Events
Forced Exercise Voluntary Exercise No Exercise
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/36 (0.00%)   0/36 (0.00%)   0/19 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Forced Exercise Voluntary Exercise No Exercise
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/36 (2.78%)   0/36 (0.00%)   0/19 (0.00%) 
Skin and subcutaneous tissue disorders       
Skin Irritation †  1/36 (2.78%)  0/36 (0.00%)  0/19 (0.00%) 
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jay Alberts
Organization: Cleveland Clinic
Phone: 216-445-3222
EMail: albertj@ccf.org
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Jay Alberts, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01636297    
Other Study ID Numbers: 1R01NS073717-01 ( U.S. NIH Grant/Contract )
First Submitted: July 6, 2012
First Posted: July 10, 2012
Results First Submitted: January 15, 2018
Results First Posted: September 26, 2018
Last Update Posted: September 26, 2018