Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE July 6, 2012
First Posted Date  ICMJE July 10, 2012
Results First Submitted Date  ICMJE January 15, 2018
Results First Posted Date  ICMJE September 26, 2018
Last Update Posted Date September 26, 2018
Study Start Date  ICMJE June 2013
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 29, 2018)
  • MDS-UPDRS Motor III Score [ Time Frame: 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.
  • Trail Making Test [ Time Frame: 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.
  • Number of Participants With Increased Motor Cortex and Thalamus Connectivity [ Time Frame: Change from baseline to end of treatment ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 9, 2012)
  • UPDRS [ Time Frame: 16 weeks ]
    The primary outcome is the change in total motor subscale score in the Movement Disorder Society-Unified Parkinson's disease Rating Scale (MDS-UPDRS) from baseline versus the three end of treatment (EOT) assessments.
  • Trail Making Test [ Time Frame: 16 weeks ]
    The primary outcome measures will be change in executive function (Trail Making Test) from baseline versus the three EOT assessments.
  • Cortical and Subcortical activation in motor and non-motor regions [ Time Frame: 16 weeks ]
    The primary outcome measure will be differences in the extent of cortical and subcortical activation within motor and non-motor regions between baseline and two follow-up sessions (EOT and EOT + 8 weeks).
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Cyclical Lower-extremity Exercise for Parkinson's Trial
Official Title  ICMJE The Cyclical Lower-extremity Exercise for Parkinson's Trial
Brief Summary The purpose of this study is to gain a better understanding of how exercise training affects motor/hand function and brain function in those diagnosed with Parkinson's disease. The investigators want to study if exercise will improve hand function and improve the level of brain activity.
Detailed Description

Current medical and surgical approaches to Parkinson's disease (PD) are expensive and associated with a variety of side effects that may compromise the patient's quality of life. Development of a non-drug, non-surgical therapeutic approach to improve motor function would provide an attractive adjunct to current PD treatment approaches. Promising results from animal exercise studies have not been translated to patients with PD.

Animal studies suggest forced-exercise produces an endogenous increase in neurotrophic factors. An increase in these factors is believed to improve the capacity of dopamine neurons to deliver dopamine and selectively increase dopamine levels within the dorsolateral striatum. Models of PD provide a theoretical framework for forced-exercise and explain why voluntary exercise is not associated with global improvements in motor function for PD patients. Based on model predictions, decreased motor cortical activation limits PD patients' ability to perform voluntary exercise at the relatively high rate used in animal studies that demonstrate a therapeutic benefit. Therefore, PD patients may not be able to exercise (voluntarily) at sufficiently high rates to trigger the endogenous release of neurotrophic factors thought to underlie global improvements in motor functioning. A safe lower extremity forced-exercise paradigm that augments PD patients voluntary exercise rates has been developed for humans in an ongoing R21 project. Similar to our initial study, PD patients completing an 8-week forced-exercise intervention exhibited nearly a 25% percent improvement in clinical motor ratings, patients completing a voluntary exercise intervention showed no improvement in clinical ratings. Our recent fMRI data indicate that an acute bout of forced-exercise in PD patients produces a similar subcortical and cortical activation pattern as is seen following administration of levodopa. Global improvements in motor function and increased neural activity suggest forced-exercise may be altering brain function in PD patients. The goal of this project is to determine and compare the effects of forced versus voluntary exercise on PD motor and non-motor function and associated changes in the pattern of neural activity.

A single-center, parallel-group, rater-blind, study in a 2:2:1 randomization is proposed. A total of 100 mild to moderate idiopathic PD patients will be randomized to a voluntary, forced or no-exercise control group. Exercise groups will exercise at identical aerobic intensities, however those in the forced group will be provided mechanical assistance to perform exercise 35% faster than their voluntary exercise rate.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Parkinson's Disease
Intervention  ICMJE
  • Behavioral: Forced exercise
    Exercise on a stationary cycle that was controlled by a motor, to augment voluntary cycling rate by 35%. Intervention was administered 3 times per week for 8 weeks
  • Behavioral: Voluntary exercise
    Exercise on a stationary cycle without motor assistance. Intervention was administered 3 times per week for 8 weeks
Study Arms  ICMJE
  • Experimental: Forced exercise
    Exercise on stationary cycle that was controlled by a motor to augment voluntary cycling rate by 35%
    Intervention: Behavioral: Forced exercise
  • Experimental: Voluntary Exercise
    Exercise on a stationary cycle without motor assistance
    Intervention: Behavioral: Voluntary exercise
  • No Intervention: No Exercise
    Participants received no exercise intervention and served as the control group
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 9, 2012)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2017
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Able to provide informed consent.
  • Clinical diagnosis of idiopathic PD. The diagnosis of PD will be based on the presence of at least two of the cardinal signs of this disorder (akine¬sia/bradykinesia, rest tremor, rigidity, gait and postural instability) with at least one of the signs being rest tremor or akinesia/bradykinesia.
  • Hoehn and Yahr stage II-III when off PD medication.
  • UPDRS motor score between 6-45 out of a maximum of 108 when off PD medication.
  • Stable anti-parkinsonian medication for one month prior to study enrollment or consistent in desire to stay off anti-parkinson medication.
  • Age between 30 and 75 years.

Exclusion Criteria:

  • Clinically significant medical disease that would increase the risk of exercise-related complications (e.g. cardiac or pulmonary disease, diabetes mellitus, hypertension, stroke).
  • Dementia as evidenced by a score less than 116 on the Mattis Dementia Rating Scale.
  • Other medical or musculoskeletal contraindications to exercise.
  • Undergone any surgical procedure for treatment of PD, DBS, pallidotomy or thalamotomy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01636297
Other Study ID Numbers  ICMJE 1R01NS073717-01( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jay Alberts, The Cleveland Clinic
Study Sponsor  ICMJE The Cleveland Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jay Alberts, PhD The Cleveland Clinic
PRS Account The Cleveland Clinic
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP