Pragmatic Cyclical Lower Extremity Exercise Trial for Parkinson's Disease

NCT04000360 | Completed Results DMC

• 1 other identifier: 2R01NS073717-06A1
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 2

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.

Conditions

Parkinson Disease

Keywords

Exercise

Outcome Measures

Primary Outcomes (1)

• Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III: Motor Examination Score

  Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III: Motor Examination score, measured off medication. Range of scores is 0 to 132, with lower score indicating better motor function.

  Baseline, 6 months, 12 months

Secondary Outcomes (8)

• 10 Meter Walk Test (10MWT) Comfortable Pace Velocity

  Baseline, 6 months, 12 months

• 10 Meter Walk Test (10MWT) Fast Pace Velocity

  Baseline, 6 months, 12 months

• Timed Up and Go (TUG) Test Duration

  Baseline, 6 months, 12 months

• Timed Up and Go (TUG) Test Turning Velocity

  Baseline, 6 months, 12 months

• Manual Dexterity Test Completion Time

  Baseline, 6 months, 12 months

Study Arms (2)

High-Intensity Exercise Group

EXPERIMENTAL

Mild to moderate Parkinson's disease patients: The exercise group will be asked to cycle 3x/week for 12 months on a Peloton bicycle which will be delivered to their home.

Other: High-Intensity Aerobic Exercise (AE)

Usual and Customary Care Group

OTHER

Mild to moderate Parkinson's disease patients, receiving no exercise intervention through the research but monitored with a parallel attention control. They will continue to receive usual and customary care for their Parkinson's disease during the 12 month period.

Other: Usual and Customary Care (UCC)

Interventions

High-Intensity Aerobic Exercise (AE) OTHER

The home-based exercise group will have a Peloton indoor cycle, heart rate monitor strap, and Garmin activity monitor to track daily activity levels delivered to the home. Participants will be asked to cycle 3x/week for 12 months on this bike with heart rate monitor at aerobic intensity 60-80% of heart rate reserve and target cadence 80-90 revolutions per minute. Study team members will telephone all participants biweekly for similar contact times between treatment groups. During these calls, a study team member reviews fall diary information, inquires about possible adverse events, and reviews participants' activity monitor wear times on the Garmin Connect website (https://connect.garmin.com). For those in the AE group, exercise recommendations, e.g., increase duration, cadence or heart rate, are given based on review of exercise session data on the Peloton portal (onepeloton.com). Compliance barriers or technical challenges with the activity monitor or exercise cycle are addressed.

High-Intensity Exercise Group

Usual and Customary Care (UCC) OTHER

Participants in this group will continue to receive their usual care. They will also receive activity monitors to monitor their daily activity levels, and telephone monitoring throughout the study. Study team members telephone all participants every 2 weeks for similar amounts of contact time between treatment groups. During the calls, a study team member of the reviews fall diary information, inquires about possible adverse events, and reviews participants' activity monitor wear times via the Garmin Connect website (https://connect.garmin.com).

Usual and Customary Care Group

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Cleveland Clinic: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator
• University of Utah: collaborator

Study Sites (2)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University of Utah

Salt Lake City, Utah, 84108, United States

Location

Related Publications (12)

• 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.

  PMID: 25046650 BACKGROUND

• 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.

  PMID: 31054035 BACKGROUND

• 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 Nov;106(11):1680-1684. doi: 10.1016/j.apmr.2025.03.046. Epub 2025 Apr 5.

  PMID: 40194736 BACKGROUND

• 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.

  PMID: 34363478 BACKGROUND

• 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.

  PMID: 28080262 BACKGROUND

• 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.

  PMID: 32925109 BACKGROUND

• 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.

  PMID: 39604309 RESULT

• 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.

  PMID: 39589012 RESULT

• 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.

  PMID: 39956037 RESULT

• 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.

  PMID: 38206881 RESULT

• 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

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 L. Alberts
• Organization: The Cleveland Clinic Foundation

albertj@ccf.org

440-708-3735

Study Officials

• Jay L 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
• Masking Details: The Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS III) will be conducted by a consistent rater, blinded as to participant randomization group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 25, 2019
• First Posted: June 27, 2019
• Study Start: November 13, 2019
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: June 18, 2025
• Results First Posted: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)