Pragmatic Cyclical Lower Extremity Exercise Trial for Parkinson's Disease (CYCLE-II)

NeuroTherapia, Inc.

Status: Completed

Conditions: Parkinson Disease

Treatments: Other: Usual and Customary Care (UCC); Other: High-Intensity Aerobic Exercise (AE)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04000360

2R01NS073717-06A1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 256 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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256 participants in 2 patient groups

High-Intensity Exercise Group

Experimental group

Description:

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.

Treatment:

Other: High-Intensity Aerobic Exercise (AE)

Usual and Customary Care Group

Other group

Description:

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.

Treatment:

Other: Usual and Customary Care (UCC)