The Cyclical Lower-extremity Exercise for Parkinson's Trial

NCT01636297 | Completed Results

• 1 other identifier: 1R01NS073717-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease

Keywords

Parkinson's disease; Exercise

Outcome Measures

Primary Outcomes (3)

• MDS-UPDRS Motor III Score

  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.

  Change from baseline over 16 weeks

• Trail Making Test

  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.

  Change from baseline over 16 weeks

• Number of Participants With Increased Motor Cortex and Thalamus Connectivity

  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.

  Change from baseline to end of treatment

Study Arms (3)

Forced exercise

EXPERIMENTAL

Exercise on stationary cycle that was controlled by a motor to augment voluntary cycling rate by 35%

Behavioral: Forced exercise

Voluntary Exercise

EXPERIMENTAL

Exercise on a stationary cycle without motor assistance

Behavioral: Voluntary exercise

No Exercise

NO INTERVENTION

Participants received no exercise intervention and served as the control group

Interventions

Forced exercise BEHAVIORAL

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

Forced exercise

Voluntary exercise BEHAVIORAL

Exercise on a stationary cycle without motor assistance. Intervention was administered 3 times per week for 8 weeks

Voluntary Exercise

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (6)

• Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.

  PMID: 38588457 DERIVED

• Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.

  PMID: 36602886 DERIVED

• Jansen AE, Koop MM, Rosenfeldt AB, Alberts JL. High intensity aerobic exercise improves bimanual coordination of grasping forces in Parkinson's disease. Parkinsonism Relat Disord. 2021 Jun;87:13-19. doi: 10.1016/j.parkreldis.2021.04.005. Epub 2021 Apr 20.

  PMID: 33932704 DERIVED

• Penko AL, Zimmerman NM, Crawford M, Linder SM, Alberts JL. Effect of Aerobic Exercise on Cardiopulmonary Responses and Predictors of Change in Individuals With Parkinson's Disease. Arch Phys Med Rehabil. 2021 May;102(5):925-931. doi: 10.1016/j.apmr.2020.12.011. Epub 2021 Jan 14.

  PMID: 33453190 DERIVED

• Rosenfeldt AB, Koop MM, Fernandez HH, Alberts JL. High intensity aerobic exercise improves information processing and motor performance in individuals with Parkinson's disease. Exp Brain Res. 2021 Mar;239(3):777-786. doi: 10.1007/s00221-020-06009-0. Epub 2021 Jan 4.

  PMID: 33394100 DERIVED

• Rosenfeldt AB, Rasanow M, Penko AL, Beall EB, Alberts JL. The cyclical lower extremity exercise for Parkinson's trial (CYCLE): methodology for a randomized controlled trial. BMC Neurol. 2015 Apr 24;15:63. doi: 10.1186/s12883-015-0313-5.

  PMID: 25902768 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Motor Activity

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavior

Results Point of Contact

• Title: Dr. Jay Alberts
• Organization: Cleveland Clinic

albertj@ccf.org

216-445-3222

Study Officials

• Jay Alberts, PhD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Staff

Study Record Dates

• First Submitted: July 6, 2012
• First Posted: July 10, 2012
• Study Start: June 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: September 26, 2018
• Results First Posted: September 26, 2018

Record last verified: 2018-08

Locations

US (1)