Clinical trial NCT04000360: Pragmatic Cyclical Lower Extremity Exercise Trial for Parkinson's Disease
Official title: Pragmatic Cyclical Lower Extremity Exercise Trial for Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Exercise
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
name: University of Utah
First posted: 2019-06-27
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 252 mild to moderate PD patients will be randomized into a home cycling high-intensity aerobic exercise (AE) group or a Usual and Customary Care (UCC) group, asked to continue normal activity level and not initiate a formal cycling program during study participation.
Primary purpose: TREATMENT

Brief summary: Identification of an effective disease-modifying intervention (e.g. pharmaceutical, surgical or behavioral) is an unmet need in Parkinson's disease (PD). Increasing evidence indicates high intensity aerobic exercise is a candidate to alter PD progression. The primary aim of this study is to examine the disease-altering capabilities of a long-term, high-intensity aerobic exercise intervention. A multi-site pragmatic randomized controlled trial design has been selected. Individuals with PD will be randomized into 1) a home-based aerobic exercise program, or 2) a usual and customary care (UCC). Subjects in the home exercise group will receive an indoor stationary bicycle delivered to their home for a 12 month exercise period. Individuals in the UCC group will continue their current level of physical activity. Motor and non-motor assessments will be conducted at the main campus of the Cleveland Clinic or the University of Utah at enrollment, 6 months, and 12 months. Each assessment will last approximately one hour.

Detailed description: Overview of Experimental Design: The study is a randomized controlled clinical trial designed to examine the disease-altering capabilities of a 12 month aerobic exercise program for individuals with PD. A total of 252 individuals with PD will be randomized into 1) a home-based aerobic exercise program, or 2) a usual and customary care (UCC). Subjects in the home exercise group will receive a commercially available Peloton indoor stationary bicycle delivered to their home for a 12 month exercise period. Individuals in the UCC group will continue their current level of physical activity. Both groups will undergo a series of motor and non-motor assessments at enrollment, 6 months, and 12 months to measure disease progression of the 12 month period. Additionally, data will be used to develop a prognostic model to predict 12-month change in Movement Disorder Society - Unified Parkinson's Disease Rating Scale III (MDS-UPDRS III) for patients participating in a home-based high-intensity aerobic exercise program.

Eligibility criteria: Inclusion Criteria:

* Adult with a diagnosis of idiopathic PD by a physician or physician extender
* Hoehn and Yahr stage I-III
* Demonstrate the ability to safely mount and dismount the Peloton stationary cycle
* In-home wireless network (WiFi; required for Peloton system exercise data transmission)

Exclusion Criteria:

* Participation in pharmaceutical or behavioral disease modifying PD-related clinical trial or study
* Diagnosis of dementia or any neurocognitive impairment that compromises one's ability to provide informed consent
* Implanted deep brain stimulation electrodes
* If the American College of Sports Medicine (ACSM) screen recommends medical clearance, the subject must obtain medical clearance by their health care provider prior to participation.
* Any musculoskeletal issue that would limit one's ability to engage in exercise
* Neurological disease other than Parkinson's disease (i.e. multiple sclerosis, stroke)

Primary outcomes:
measure: Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III: Motor Examination Score
timeFrame: Baseline, 6 months, 12 months
Secondary outcomes:
measure: 10 Meter Walk Test (10MWT) Comfortable Pace Velocity
timeFrame: Baseline, 6 months, 12 months
measure: 10 Meter Walk Test (10MWT) Fast Pace Velocity
timeFrame: Baseline, 6 months, 12 months
measure: Timed Up and Go (TUG) Test Duration
timeFrame: Baseline, 6 months, 12 months
measure: Timed Up and Go (TUG) Test Turning Velocity
timeFrame: Baseline, 6 months, 12 months
measure: Manual Dexterity Test Completion Time
timeFrame: Baseline, 6 months, 12 months
measure: Processing Speed Test Match Score
timeFrame: Baseline, 6 months, 12 months
measure: Trail Making Test (TMT) B to A Duration Ratio
timeFrame: Baseline, 6 months, 12 months
measure: Visual Memory Test Symbol Recall Score
timeFrame: Baseline, 6 months, 12 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: The Cleveland Clinic
name: Jay L Alberts, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rudick RA, Miller D, Bethoux F, Rao SM, Lee JC, Stough D, Reece C, Schindler D, Mamone B, Alberts J. The Multiple Sclerosis Performance Test (MSPT): an iPad-based disability assessment tool. J Vis Exp. 2014 Jun 30;(88):e51318. doi: 10.3791/51318.
citation: Rhodes JK, Schindler D, Rao SM, Venegas F, Bruzik ET, Gabel W, Williams JR, Phillips GA, Mullen CC, Freiburger JL, Mourany L, Reece C, Miller DM, Bethoux F, Bermel RA, Krupp LB, Mowry EM, Alberts J, Rudick RA. Multiple Sclerosis Performance Test: Technical Development and Usability. Adv Ther. 2019 Jul;36(7):1741-1755. doi: 10.1007/s12325-019-00958-x. Epub 2019 May 3.
citation: Rosenfeldt AB, Penko AL, Jansen AE, Lopez-Lennon C, Zimmerman E, Imrey PB, Singh TK, Dibble LE, Alberts JL. Refining Maximal Heart Rate Estimation to Enhance Exercise Recommendations for Persons With Parkinson Disease. Arch Phys Med Rehabil. 2025 Apr 5:S0003-9993(25)00626-4. doi: 10.1016/j.apmr.2025.03.046. Online ahead of print.
citation: Alberts JL, Rosenfeldt AB, Lopez-Lennon C, Suttman E, Jansen AE, Imrey PB, Dibble LE. Effectiveness of a Long-Term, Home-Based Aerobic Exercise Intervention on Slowing the Progression of Parkinson Disease: Design of the Cyclical Lower Extremity Exercise for Parkinson Disease II (CYCLE-II) Study. Phys Ther. 2021 Nov 1;101(11):pzab191. doi: 10.1093/ptj/pzab191.
citation: Rao SM, Losinski G, Mourany L, Schindler D, Mamone B, Reece C, Kemeny D, Narayanan S, Miller DM, Bethoux F, Bermel RA, Rudick R, Alberts J. Processing speed test: Validation of a self-administered, iPad(R)-based tool for screening cognitive dysfunction in a clinic setting. Mult Scler. 2017 Dec;23(14):1929-1937. doi: 10.1177/1352458516688955. Epub 2017 Jan 12.
citation: Alberts JL, Rosenfeldt AB. The Universal Prescription for Parkinson's Disease: Exercise. J Parkinsons Dis. 2020;10(s1):S21-S27. doi: 10.3233/JPD-202100.
citation: Jansen AE, Rosenfeldt AB, Lopez-Lennon C, Fernandez H, Zimmerman E, Imrey PB, Dibble LE, Alberts JL. Characterizing Hand Function in Parkinson's Disease Patients with a Self-Administered Electronic Manual Dexterity Test. Mov Disord Clin Pract. 2025 Mar;12(3):333-339. doi: 10.1002/mdc3.14286. Epub 2024 Nov 27.
citation: Rosenfeldt AB, Jansen AE, Lopez-Lennon C, Zimmerman E, Imrey PB, Dibble LE, Alberts JL. Physical Activity Declines over a 12-Month Period in Parkinson's Disease: Considerations for Longitudinal Activity Monitoring. Med Sci Sports Exerc. 2025 Apr 1;57(4):738-745. doi: 10.1249/MSS.0000000000003615. Epub 2024 Nov 26.
citation: Anis S, Zimmerman E, Jansen AE, Kaya RD, Fernandez HH, Lopez-Lennon C, Dibble LE, Rosenfeldt AB, Alberts JL. Cognitive measures predict falls in Parkinson's disease: Insights from the CYCLE-II cohort. Parkinsonism Relat Disord. 2025 Apr;133:107328. doi: 10.1016/j.parkreldis.2025.107328. Epub 2025 Feb 11.
citation: Rosenfeldt AB, Lopez-Lennon C, Suttman E, Jansen AE, Owen K, Dibble LE, Alberts JL. Use of a Home-Based, Commercial Exercise Platform to Remotely Monitor Aerobic Exercise Adherence and Intensity in People With Parkinson Disease. Phys Ther. 2024 Feb 1;104(2):pzad174. doi: 10.1093/ptj/pzad174.