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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by The Cleveland Clinic
Sponsor:
Information provided by (Responsible Party):
Jay Alberts, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01636297
First received: July 6, 2012
Last updated: August 1, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Parkinson's Disease
Behavioral: Forced exercise
Behavioral: Voluntary exercise
Behavioral: No-exercise/control
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Cyclical Lower-extremity Exercise for Parkinson's Trial

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • UPDRS [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 100
Study Start Date: June 2013
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Forced exercise Behavioral: Forced exercise
Exercise on a stationary bicycle 3 times per week for 8 weeks
Experimental: Voluntary Exercise Behavioral: Voluntary exercise
Exercise on a stationary bicycle 3 times per week for 8 weeks
Experimental: No Exercise Behavioral: No-exercise/control
No exercise intervention is given. This group serves as a control group.

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.

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01636297

Contacts
Contact: Liz Jansen, B.A. 216-445-3866 jansena@ccf.org
Contact: Amanda Penko, M.A. 216-636-9717 penkoa@ccf.org

Locations
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Amanda Penko, M.A.    216-636-9717    penkoa@ccf.org   
Contact: A. Elizabeth Jansen, B.A.    216-445-3866    jansena@ccf.org   
Principal Investigator: Jay Alberts, PhD         
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Jay Alberts, PhD The Cleveland Clinic
  More Information

No publications provided

Responsible Party: Jay Alberts, Associate Staff, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01636297     History of Changes
Other Study ID Numbers: 1R01NS073717-01
Study First Received: July 6, 2012
Last Updated: August 1, 2013
Health Authority: United States: Federal Government

Keywords provided by The Cleveland Clinic:
Parkinson's disease
Exercise

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on July 23, 2014