Pragmatic Cyclical Lower Extremity Exercise Trial for Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Pragmatic Cyclical Lower Extremity Exercise Trial for Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04000360
• Other study ID #: 2R01NS073717-06A1
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: November 13, 2019
• Est. completion date: April 30, 2023

Study information

• Verified date: June 2023
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 256
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• High-Intensity Aerobic Exercise
The home-based exercise group will receive a Peloton indoor cycle delivered to their home and a heart rate monitor strap. Participants will be asked to cycle 3x/week for 12 months on their bike with their heart rate monitor at an aerobic intensity between 60-80% of heart rate reserve with a target cadence between 80-90 revolutions per minute (RPMs). Additionally, participants (both groups) will receive activity monitors to monitor their daily activity levels.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Processing Speed Test	Change in score for the Processing Speed Test Score will be compared between exercise arm and UCC group. The score is the number of correct responses over a two minute testing time. Higher scores indicate improvements in processing speed.	Baseline (on and off medications), 6 months (off medications), 12 months (off medication)
Primary	MDS-UPDRS III Motor Score	Change in MDS-UPDRS III Motor Score will be compared between the exercise arm and the UCC group . Administered by a blinded rater, used to examine global motor function and disease severity. The change in Motor Score from the MDS-UPDRS III will be utilized. A lower score indicates improvements in motor function.	Baseline (on and off medications), 6 months (off medications), 12 months (off medication)
Secondary	Nine Hole Peg Test	Change in overall time for the Nine Hole Peg Test Score will be compared between exercise arm and UCC group. Faster time (measured in milliseconds) at the conclusion of the intervention indicates improvements in manual dexterity.	Baseline (on and off medications), 6 months (off medications), 12 months (off medication)